f california. something she cares deeply about. and she is extremely effective at it. i do work in the congo. i see that as a microcosm of what this government can be. we can do both. we can do all these things. be they outside our national borders or within. i believe that is what america is. >> that's probably the best hearing i have attended in a long time. they were -- you represent the best of our country. in two hours, we will go fight for it. thank you. the hearing is adjourned.

harry reid is calling it a career after five terms in the u.s. senate. he announced today that he will not seek election to a six term. he released a statement that

said, i have had time to ponder and to think and got to be more concerned about the country. the senate and the state of nevada than about us. as a result, i'm not going to run for reelection. here's a look at portion of his video announcement where he talks about his plans for the remainder of his term. >> this accident has caused us for the first time to have a little downtime. i have had time to ponder and think we day -- that we have to be more concerned about the country, the senate, the state of nevada and us. as a result of that, i am not going to run for reelection. my friend senator mcconnell, don't be too elated. i will be here and i will be doing the same thing i have done since i came to the senate. >> the national republican senatorial committee did not take long in reacting. on the verge of losing his own

election and losing the majority, senator reid has decided to hang up his rusty spurs. his retirement signals there is no hope for the democrats to regain control of the senate. with the exception of harry reid every statewide official in nevada is republican. that's a statement from the republican national senatorial committee in reaction to senator harry reid's retirement announcement today. no final word on who'll replace senator reid. he is endorsing new york senator chuck schumer to succeed him and produce -- predicts dick durbin will stand it down. we are also hearing from you on minority leader resignation. well done, someone willing to dedicate so much of their life to public service is very respectable. also jamie has this to say, he

needs to resign now. he also needs to be brought up on charges. we invite your reaction at facebook.com/c-span. dr. or margaret hamburg will be speaking with the national press club today. she will talk about her time at the agency, which is coming to a close she announced her departure. you can see her remarks live at 1:00 eastern here on c-span. here are some of our featured programs for this weekend. on c-span two saturday at 10:00 p.m. east during on afterwards, author peter wallison government -- director of the earth institute at columbia university jeffrey sachs on a development plan to counter global issues like poverty political corruption and environmental decay. and saturday morning at 1030 eastern on american history tv

of c-span3, a discussion on major speeches of abraham lincoln and martin luther king junior. sunday afternoon at 4:00 unreal america, the 1965 meet the press interview with martin with -- martin luther king junior. find the complete schedule at c-span.org and let us know about what you think about the programming. e-mail us at c-span.org. join the c-span conversation. like us on facebook, follow us on twitter. a discussion on recent support supreme court regarding epa controls on power plant emissions, and whether the cost of limp lamenting the restriction should have been considered. from this morning's washington journal. host: joining us is jeremy jacobs with a group called greenwire. guest: greenwire is part of being a publishing.

it is a nonpartisan subscription service. our newsreaders are from federal agencies, everywhere from the sierra club to exxon mobil. they pay to subscribe what we write. host: what is it that differentiates you from some of the other publications? guest: we are highly specialized. we cover everything for the environment and energy, either in the courts, which is what i in the courts what i cover and capitol hill cover, or the department of the interior and department of energy. we are hyper focused on those things. host: this week, there was a supreme court hearing, she can versus -- michigan versus epa. guest: it is a consolidation of three cases, one being brought by michigan and 20 other states, challenging a 2011 role that the epa finalized.

it was the heart of its air program to regulate emissions of toxic pollutants like mercury, cadmium, lead, arsenic from coal fire plants. to make that rule, the epa first had to determine that it was "appropriate and necessary" based on what the eps said was health risks. the states and other utility groups challenge that, saying that the epa in that initial determination, we for setting the standard should have considered costs. these are very expensive rollouts. the technologies cost a lot. $9.6 billion is with the epa said this would cost. so the challengers content that "appropriate necessary" should have included cost. host: the epa rules, with a based on a congressionally passed law? guest: that's right.

they came straight out of the clean air act. when it was amended in 1990, in order to get at these pollutants that so far have not been regulated, congress directed epa to do a "utility study." looking at the health effects from emissions that come out of power plants, and determine if those pollutants were still on the rise and still posed a health risk. then they should go ahead and issue standards for them, which is what the epa did in obama cost administration. host: "appropriate necessary," are those words in the law? guest: they are. host: who interprets that? guest: it is a very vague term. the law does not say, just consider health effects great it does not say consider help effects and costs. it is silent on that.

the case hinges on whether epa permissibly interpreted appropriate and necessary to just focus on health effects. where is the challenger say cost should have been part of that. host: jeremy jacobs, who calculates these costs or the benefits of such a loss? guest: that is also an issue in this case. the epa, when it did its cost analysis that it would cost 9.6 billion, and suggested that the benefits of this rule will be between 30 billion and 90 billion. on that scale, the benefits clearly outweigh the costs. the challenger say that if the epa got by that by counting co-benefits, not mercury and not these other pollutants, if you are only counting knows, the benefits are only 4 million to 6 million versus 9 billion. that skews the cost analysis

quite a bit. host: 202 is the area code if you would like to talk about this particular case, or the obama administration's environmental issues. go ahead and dial in. we will begin taking those calls right away. is this case about president obama's environmental policy? guest: in a lot of ways it is. this is the third time in a year the supreme court has reviewed a major clean air act regulation of the obama administration's issue. his epa has done very well. it won a case on an air pollution program for pollution that crosses state lines. one that last year 6-2. and initial greenhouse gas regulations. this program, called the mercury

-- the pollution controls that are installed because of it help the obama's epa and a lot of other ways, too eared a lot of other companies it wants to implement a benefit from these controls, should this regulation be upheld. host: what was the reaction from the justices? guest: very hard to say. it is safe to say, it was probably -- pretty fairly split. you have the four conservative justices, all had very large misgivings about whether epa should have considered cost. scalia at one point called it an outrageously expensive law and the chief justice several times said that there are red flags and asked whether epa has unusually tied its hands by not considering costs.

the liberal justices the local justices really leapt to epa's defense, saying that when the law is silent, what you have to consider in this appropriate and necessary determination, deference goes to epa's interpretation. host: this is from the washington post on this case. supreme court appears split on toxic emissions plan, is the headline. states and industries opposing the regulations say that the annual cost of compliance under the rule would be $9.6 billion but that the benefits of reduced emissions of hazardous air pollutants are only $4 billion to $6 billion. the epa and environmental groups estimate the savings to be much more, from $37 billion up. how are those been calculated? guest: it is 4 million to 6 million, they say, not billion.

host: it says "billion" here. guest: the difference -- and this is kind of complicated cash when the epa does its cost benefit analysis, they were including these co-benefits of reducing other pollutants like set, like small particles. those are not the namesake pollutants of this rule, where is the namesake pollutants cadmium, lead, that is where industry comes up with the $4 million to $6 million number. epa would also counter that reducing mercury emissions which are as we know a potent neurotoxin, it is very hard to quantify the health benefits of that other than to just say,

things are better with it not being in the air. it is hard to numerically quantify exactly how much benefit there is. host: is this all about coal? guest: this is all about coal. these are coal-fired power -- power plants should a lot of the coal power industry is already complying with this regulation. it is due to come into effect next month, is when compliance is supposed to begin. almost two thirds of the coal industry is already complying. it is only about 20% that has yet to make up its mind about how they will comply. host: jeremy jacobs, legal reporter with greenwire. jay, you are on the air raid caller: good morning. i am very proenvironment but at the same time, we have to realize that just lie us

breathing, we change our environment. this rush to shut down, even bankrupt coal in many places is just, it leaves my headshaking. here in ohio, we are in the process where have our ready shutdown a number of coal-fired plants. i look at the scenario. we also have two old-style nuclear power plants which at some point in the near future, they will be shut down just because of their age. i am curious, where do we go with this? because at some point, someone will turn on an air conditioner and we will have the great lakes blackout all over again. any ideas where we are going? obviously, the renewable energy is not going to service us

anytime soon, at least in this country. host: j, thank you very much. guest: i think those concerns are real. epa would say that there is no real risk of any blackout happening because of this mercury rule in the near future. as i mentioned earlier, the fact that two thirds of the country including a lot of ohio is already complying, would indicate -- and the blackouts have not occurred yet -- would indicate they will not have two devastating of an effect. one way that this is being addressed is the switch to national gas -- natural gas, switching coal-fired plants to burning national gas -- natural gas, which is a cleaner imaging fuel. that seems to be accomplishing a lot of what the epa is seeking to accomplish.

host: kayla, oakland, new york. democrats line eared caller: good morning. my comment is not specifically on -- host: turn down your tv and listen to your telephone. caller: is this ok now? host: please go ahead. caller: my comment is not specifically on the rules on coal but more on the rules that the epa should be allowed to promulgate on global warming concerning co2 emissions because i am scared to death of it. if you follow the science, it is really frightening, the depth of the ocean, all sorts of stuff like that i literally get so scared i cannot look at the reports because they are frightening.

i we take control of these emissions, i feel we are in big trouble. guest: i think that there are many people that share your concern about climate change. the obama administration has proposed for the first time standards limiting carbon dioxide, greenhouse gas emissions from the power sector. those were proposed last summer. they are supposed to be finalized this year. they will cut greenhouse gas emissions significantly from 2005 levels. notably, those have already been challenged in federal court, and they will be argued next month. it is unusual for a rule to be challenged before it is finalized, but it will be interesting to see how that plays out. host: tony is calling in from north conway, new hampshire, republican line.

we are talking about the environment, the obama administration, and supreme court cases. caller: if we are really concerned about carbon emissions, what they should be focusing on our developing nations like china and india. they are putting out these massive amounts of pollution based off of old, antiquated technologies that we could really update by putting on tariffs for their pollution and opening up patents to them so that they could have greener technologies. that is stuff we can do today. china puts out roughly 25% of the world's carbon emissions and that is something we can immediately lower with the technologies that we have. guest: yes, i think that is a good point and shortly after the midterm elections, you did see the white house and the

president making some international deals or agreements to address climate change. fundamentally, the rules that i just mentioned, the ones that are proposed to deal with greenhouse gases from power plants, those are sort of a linchpin to those negotiations because they show that the united states is taking this seriously and the united states is doing something. that is a big part of our negotiations with countries like india and like china, in order to force them to do more. host: is this a republican versus democrat issue? guest: on the hill, it sort of is, especially in -- we are coming out of an economic downturn. this $9.6 billion number as the cost of these mercury rules, something that really upsets the

conservative lawmakers. and so yeah, it has been criticized quite harshly on capitol hill. host: has the supreme court confronted a similar case when it comes to, are we weighing the costs, is that something the supreme court should be looking at? guest: it has. the epa has typically fared very well. the liberal justices, during arguments, noted -- i think ruth bader ginsburg said something to the effect of, can you think of a single case where the wall -- where the law does not instruct the epa to consider cost? we say it has to. elena kagan followed up saying going from silence in the law to making it a requirement seems like a pretty big jump. there is a case, another clean air case around 2001, i believe,

that had to do with ozone standards were the court deferred to epa's decision to consider cost. then there was a clean water act case where the court deferred to epa's decision to do a cost-benefit analysis. host: next call for jeremy jacobs comes from jim in ithaca, new york, jim, you are on the "washington journal." caller: thank you so much for mr. jacobs answering my question. you hear a lot in the media air pollution from power plants. but the association of commissions for the environment has maintained for the past several years that driving an automobile is the worst thing that you can do for the environment. we never hear anything about that in the media. as a dedicated pedestrian, i

have to say that it just seems like the air is heavily polluted so just from automobiles. guest: i sympathize, as i would consider myself a dedicated pedestrian as well, and a bicyclist, but you are right. a lot of reason you do not hear much about car emissions is we have already done a lot, as far as cleaning up cars, car emissions. there have been several tailpipe standards, including an acceleration of them during the obama administration that was promulgated in his first term between epa and the department of transportation. they have already taken steps to start curtailing auto emissions and of course, these play out over 20 to 30 years. i think one reason is we have seen a lot of progress in that area.

host: does congress still write laws that say "appropriate and necessary," thus being vague? guest: it does. that also came up in the argument how common "necessary and proper," which is in the constitution, how often those come up and how vague they can be. it did come up in the argument how commonly these words are used. host: is this considered by some as an unfunded mandate? guest: i do not believe so. i guess it sort of is because all of the cost is shepherded by industry having to make the technology improvements. but you do not hear that phrase associated with this too often. host: mike, lemoine, pennsylvania, independent. caller: i was wondering if your guest could explain to the

american people that the reason there is an epa in the first place is on account of corporate americans really bad behavior. there was a gigantic uproar to do something about things like the canal, really upset people. corporate behavior would have been better in the first place maybe the epa would not be so significant. guest: a very good point. the major environmental statutes that we have, the clean air act, the clean water act, those were passed in the 1970's. they all passed with overwhelming bipartisan support. richard nixon established the epa so there has been quite a change as far as the polarizing nature of these regulations and these laws. you're absolutely right.

rivers are not on fire anymore as happened in ohio. you cannot see the pollution as much as you could but you are absolutely right, these initiatives were passed into some really terrible environmental disasters. host: a few moments left with our guest. caller: good morning. i have been in facilities in 12 countries in 10 states and two points, when his on ice cores and congressional responsibility. if you will pull at the history channel two, they are running a series on showing that the earth's temperature has gone up and down for hundreds of thousands of years. and this is really silly looking at carbon emissions. i do believe that we should be looking at pollutants and their

effect on health. but here is a major, major point. the constitution says that congress is supposed to write laws and i propose that we force all the bureaucrats in the executive branch who are writing laws to be transferred to congress and be paid by congress , supervised by congress to work out all these details. we should not write such vague laws. guest: i think you hit on something. as i mentioned, it gets at the heart of the supreme court case, and that is what to do when agencies interpret unclear or ambiguous laws. i think that there is a concern that the supreme court about that i share -- that i think shares your concern about too

much regulatory power or regulatory ability to craft what some say is law. the counter of that argument congress has not been particularly active in a lot of areas, updating laws that needed to be updated or new laws giving these agencies more guide. that leaves to the newer problems for the agencies to deal with. host: jeremy jacobs, does the obama administration -- how focused are they on an environmental legacy? guest: i think focused. i think that the president came into office saying he was going to tackle climate change issue. he immediately all must issued a first round of greenhouse gas regulations that included tailpipe standards, and has proceeded over the next three to

four years to then roll out another set of rules, which are now in the process of being finalized. i think he has moved fairly aggressively to try to submit and legacy, and a large part of that are these international talks. as our caller mentioned, there is a record that the biggest polluters are china and india. mary jane. republican. caller: that was just mentioned, what i was going to bring up. there was a call earlier that china has really got some outmoded factories and things. if we would put our resources into helping them there, it would be better put. right now, our president has made an agreement with the chinese that we will cut our things now even more than we have already done, and china can

wait for another 30 years until they start to implement anything. it seems to me 30 years is too long in this day and age. we could be cutting their emissions, and make a real, true difference to our world. know, and make a real, true difference to our world. that is all i have to say. we should do that. guest: obviously, diplomatic relations with china are somewhat complicated. i do think there has been a recognition in the administration that you are right, china needs to be addressed. but i think there is only so much they can do. if you follow this closely, there was recently a film that was released in china by a journalist who is pregnant and has been adversely affected by the pollution levels there. that film received a ton of attention. in the country, and whether or not that will spur any sorts of

changes is yet to be seen. but china's pollution problem is quite significant. host: jeremy jacobs. green bar. guest: green wire germany. -- jeremy. host: thanks for being on the "washington journal." >> harry reid announced today in a video that he will not seek reelection to a sixth term in the senate. we have to be more concerned about the country, the senate, the state of nevada than ourselves. and as a result of that, i am not going to run for reelection. the national republicans editorial committee has released a statement that reads, on the verge of losing his own election, senator harry reid has decided to hang up his rusty spurs. not only does he instantly become irrelevant any lame-duck

his retirement signals there is no hope for the democrats to read -- regain control of the senate. we are also hearing from you on minority read's -- on his announcement. linda says -- david says, good riddance to the worst obstructionist in the senate history. and linda says, thank you for your service and your fight for the american people, harry. she is expected to talk about her time at the agency. that is coming to a close, when she announced her departure not too long ago. you can see her remarks live in just under half an hour here on c-span. until then, a discussion on the future of college fraternities in light of recent campus scandals. host: and is the party over is the question that ian tuttle

asked. here is the cover. ian tuttle, what are the advantages and disadvantages of the greek system? guest: that is a big question. researching this piece, i discovered that it did not lend itself to a cover piece in a magazine. it lends itself to a book or perhaps several volumes of books . the disadvantages unfortunately have been, at least the potential problems have been made clear. i'd say over the past six months as we have seen at least does -- at least to -- two large events that have become national news moments. the first was the now debunked sexual assault or gang rape at the university of virginia

reported in rolling stone during as we now know, that is false. it started a discussion on college sexual assault and the relationship to fraternities. the second was the race chat -- racist chants from sae. fraternities seem to have fallen a foul of these two fracture lines that we have in american society, sex and race. the question of course is whether that is fatal, whether it should be fatal given the advantages of the greek system which are many. you have social capital. you have community life. you have the enormous philanthropic work that fraternities and sororities do and we can talk more about the specifics of those things. but the question is, is there a

balance to be struck or has the greek system sort of outlived its usefulness? host: one of the things you bring up in your national review piece is that fraternities and sororities have become insurance conglomerates to mitigate the risk associated with eating -- being organizations composed of 18 to 24-year-old heavy drinking males , a level of liability apparently equivalent to that of handling nuclear waste. guest: that is right. this is not original to me. it comes from an excellent article by caitlin flanagan, " the dark power of fraternities in the atlantic" in march 2014 i believe. ms. flanagan spent a year researching the greek system all across the united states and she makes this point, and i pick up on it. essentially, what happens is if

you look at the history of the greek system, there is a period of significant contraction in the late 1960's and early 1970's, when the greek system really diminishes nationwide and there are various reasons for that. and then in the mid to late 1970's, it makes a comeback good part of that is the premiere of "animal house," the famous john belushi movie, sort of proffered or propagated a new vision of fraternity life. and so you see fraternities expand once again and what a lot of fraternities discovered over the course of the 1980's is that the liability they held for personal injury was potentially ruinous. you have people falling off balconies. you have the heavy drinking.

you have all sorts of potential problems that they have to face. so, what happens is fraternities that at the local level are rivals, the sort of famous inter-house competition, at the national level band together and form huge insurance conglomerates. they write risk management policies, all of these sorts of things. they sort of start to group their finances together. what that helps them do with the assistance of enormous legal teams is ensure that the fraternity organizations themselves do not go under if one incident happens at some fraternity at some campus. so, this does create a tension which is that on various

occasions, the behavior of individual fraternity members and the conduct of the national organizations is at odds or in tension. so the national organizations are eager to distance themselves, obviously, from what happens at the individual level. and they have created legal structures that enable them to do that. so in a sense, fraternities, the individual fraternity that you would experience on any particular campus is in some way at a huge remove from what is essentially a corporate structure at the national level. that is one of the ways in which fraternities have insulated themselves against the sort of incidents that we see nationwide. host: we have divided our phone

lines for this segment. we will be talking about the greek system, the future of fraternities, etc. based on his cover story in the national review, phone lines are divided just a little bit differently today so if you happen to work at a college and you are a professor or an administrator, we would like to hear your point of view, (202) 748-8000 for is the number for you to dial. if you are a college student 202-748-8001 all others, 202-748-8003. certainly, we want to hear from members and former members of fraternities as well. halfway through your piece, mr. tuttle, we have painted -- and -- you're right, we have painted

-- and it is hardly fair to most fraternity members who regularly report and -- an overwhelmingly positive experience of greek life and not just because of the easy access to alcohol. there is evidence to suggest that members of fraternities and sororities earn marginally better grades than non-greek peers, they are more engaged to civic opportunities, and that they are more philanthropic, etc., etc. guest: right. and this is significant. there is a reporting bias when it comes to greek life on campus and i tried to address that in the piece. that is, we hear about the bad things. it makes for good stories. you are not going to hear about the university of idaho's

fraternity that raised $50,000 for alzheimer's research, or whatever the case may be. it just get enough news traffic . so you have to recognize that fraternity culture, the greek system nationally being a huge thing, is doing a lot of good work, has a lot of advantages that you will never hear about. what are some of those? i address them there. there is evidence, like i write they have marginally -- members of greek life have marginally better academic performance. a large part of that is due to community, the fact that being part of a fraternity or sorority is a way in which, is perhaps one of the best ways to get right into the bloodstream of

the social life and social existence of a college campus. so what you see in fact are -- is that at many universities there is a lot of overlap between fraternity and sorority members and fraternity and sorority leaders, and leaders of other campus organizations. you see that as well later in life. if you look at the presidency, broadly, the majority of presidents since 1867 have been fraternity members. the majority of fortune 500 ceos in the united states, a huge number of congressmen both on the house side and on the senate

side, were involved in sororities or fraternities. so there is a lot of evidence to suggest that greek life creates, or at least helps to mature people who are going on to positions of social or political responsibility more broadly. finally, you have a huge amount of philanthropic work that fraternities and sororities themselves are doing each day, and it is a question i think whether that is philanthropic -- that philanthropic work would continue if you did away with the greek system. i am inclined to believe that it wouldn't, in part because the philanthropic work is encouraged because there is a community based on something more than just that community service. you have essentially what is a

large extended family. so when the leaders of the sorority or fraternity say we are going to do this thing everybody bonds together and does it. you are likely for that process to be a lot more fruitful in terms of dollars, in terms of hours of work. so those are a number of advantages that you see in the greek system, and i think it is important that we do not downplay those. host: ian tuttle, which saint john's college did you attend and were you a member of a fraternity? guest: i was at the st. john's college in annapolis, maryland and no, i was not a fraternity member. at a school of about 450 to 500, we did not have a greek system. everybody would have been in the same fraternity ors -- or sorority. so i do come to this from an outsiders perspective.

and there is a certain difficulty to that. it is true that for those of us on the outside, who want to get insight into this world, there is a difficulty in part because of that reporting bias. you are looking from the outside and you're often relying on media reports, which tend to slant one way. and a lot of people involved in greek life will tell you that if you were not involved, you cannot understand it. there is something to be said for that immediate first-person experience. on the other hand, greek -- members of greek life are, as i said in the article, regularly report that they have positive -- had very positive experiences. it is difficult for someone writing about this to try to

strike some balance and to be objective, whether you were or were not in a fraternity. i hope i managed to come close to that balance. host: let's take some calls for ian tuttle of national review. let's begin with mark in ohio. caller: thank you for c-span. my whole bend on this is that it is -- hello? host: mark, keep talking, we are listening. caller: is that it has been all a negative thing in our society, as much as they want to propose that the greek ways is the way. i have noticed in my experience in life that these people often get appointed to jobs they are not even qualified for because they are with the brotherhood of this or that. it promotes cronyism, which is negative. it promotes that secret society

type of thing that is running our country -- has ruined our country. it is that whole club mentality of the pseudo-aristocratic people. it has just been a real bad thing. it is not anything that i would let my child, if i had one, ever consider doing unless they were old enough to go that way, but i would pull them from it if i could. it is not the way things should be. it is that whole club mentality that is ruining america. host: that is something you write about, ian tuttle, the club mentality or socialization. guest: right. so, i think there was an important word in there and that is "aristocratic." i think that is true of greek life and i do not mean that necessarily badly. it is a determination that we have to make but the case that

greek life runs against the egalitarianism mentality that we tend to have as americans, we tend to want to have essentially a meritocratic criteria for entry into any organization. and fraternities and sororities often do not work like that. the question of rush, the question of becoming involved very often does not have to do as much with sort of, concrete quantifiable assets that you can bring to the organization as much as a broader, somewhat nebulous evaluation of who you are, your identity, and whether

you as a person or the type of -- are the type of person that we like, that we want to be involved with. that runs against something that -- it runs against in a certain way the american mentality. although, the problem is all communities are to a certain extent based on that. they are based on a criteria that ultimately are somewhat ineffable and the communities that form, that fraternities and sororities form, are intensely strong in a way that organizations based on common ends hs -- a chess team or even

an athletic organization, or not -- and there are significant goods to that part of it. it is a benefit to character. these sort of qualities that do not lend themselves to being measured. but the caller's point is well taken in the sense of a club mentality and whether we can tolerate that broadly because it is true that there is a nepotism that comes along often with fraternity life. there is a question of whether the evaluations, the sort of implicit evaluations that are made by fraternities and sororities are ultimately beneficial. in certain cases, i think so. in others, they become much more problematic.

host: bob is in pop, michigan. caller: mr. tuttle, the him -- the fact that you are not a member of a fraternity shows up in your positive statements. i was a member before i sobered up after about a year and a half, and i got a tell you, the words "future" and "fraternity" have nothing in common. they sure do not have a future today. those two are incompatible. host: but why, bob? caller: the greek alphabet is so dead that many of the reports written on sae cannot even use the greek letter s and it -- and it because it does not -- in it because it does not

seem to exist in people's computers. if i was the society of automotive engineers, i would have an army of lawyers doing a class action suit to make sure that the english letter s never appears in those articles. i would sue any group that mistakenly used that. host: bob, why do you say that -- caller: it needs to die, sir. host: why do you say that? any comment for that caller, mr. title -- tuttle? guest: the future of fraternities -- and i do think i have one -- is complicated. the distinction i made between individual chapters and national organizations toward the beginning of our conversation is an important one. you have a lot of -- you have hundreds if not thousands of individual fraternity chapters at individual campuses. they are frequently going in and

out of existence. their charters get disbanded they get reinstituted. there is a lot of flux at the individual level. at the national level, where you have these corporately structured fraternity organizations, they have very deep pockets, large legal teams, and they have spent two decades, almost three decades creating legal structures to indemnify themselves against liability. the other thing is that the alumni network of fraternities and sororities as well, is massive. there are also huge donors to universities. so you have two things. one is a very complex, not always beneficial relationship between fraternities and university administrations and

then you have the national organizations, which can survive based on the enormous financial capital and sort of legal structures that they have to protect themselves. so i do think that there is a future of fraternities. the question is whether it is going to be a future that is ultimately fruitful for individual members of fraternities and sororities at campuses across the nation, and whether it is beneficial to our society at large. host: jennifer is in michigan. hi, jennifer. it helps if i push the button. jennifer. portage, michigan. caller: hi. thank you for taking my call. i appreciate it. first of all, i am an african american woman.

i am very pro-fraternity and sorority. they do a lot of wonderful things. i have never wanted to be in a sorority because i did not have the time going through college but i will tell you one thing, we are making such a big stand -- distinct ever since -- stink ever since that young man got on the bus and said what he said. all fraternities and sororities -- it is a lot of ways to get networking through these organizations and i want to tell you, my son is in an all-white fraternity. only two african-american males. those kids come over here, they have no problems. we get so much negative intact -- impact and what is taking place now. there was a reality show that showed two black sororities feuding against each other totally not true. i do not want to say the name of one sorority, they do so much to help in the education field, but you know what? we look at the press and find the worst things possible in these organizations and put it

out there. it is a great way. networking is good. that is how kids find jobs when they finish college. it is not just for -- fraternities and sororities. it is alumni's of colleges. you know what? we need to give them a break. we need to give a kid a break. people make mistakes. you know what? let's see what is positive that is taking place with fraternities and sororities, because they do do a lot of good things. yeah, if you want to party all the time, as the gentleman said, you have got to have common sense as well. not everyone goes off and gets drunk every night. host: that is jennifer in michigan. ian tuttle of the national review. guest: yeah, that is quite right. and that speaks to the reporting that i mentioned before. that we hear the bad things that make for bats -- for good

stories here. there is another point she made which i think is important which is that fraternities to a certain extent are not unique in the type of thing that they are doing. fraternal order of police is another example. fraternities are a lot like -- well, we used to have sort of men's and women's clubs that were social in nature, rotary, elks, those sort of things which were doing the same things for professional men and women. and you also have the type of bonding that goes on in the military in basic training, boot camp. the types of things that go on there are very similar to the ways in which fraternities bond young men together. so it is worth sort of keeping perspective in that regard.

host: william is calling in from punta gorda, florida. hi, william. caller: hello? host: you are on the air, please go ahead. caller: ok. yes. i am african-american. and i have experienced some of the greek systems. my comment is, when you look at the qualifications for being greek in the white fraternities, it is all about economics. because i have heard -- the as -- ask how much money your parents make. that determines the greek fraternity or sorority. within the black fraternities and sororities, that economic money process is not fair. so, i look at what happened in oklahoma as something similar to trying to enter a country club now. as an african-american minority that has been 99% white, when you look across the country at different universities and so

forth, there is still not a lot of diversity. i think the qualifications for membership is economics or money first. when you do those types of things, you are not going to have a lot of african-americans or other minorities the opportunity to get in. in so i was called the n word, as well, i campus. -- on campus. so i think that this is an eye-opener in a way. and i think that the fraternities, and even the sororities because it is on both sides, need to be evaluate the . -- reevaluate the membership process because there are some african-americans now who have money. their families have that money. but the issue of racism and elitistism, and what really makes a fraternity a fraternity when you look at these colleges campuses and the qualifications that need to be addressed.

host: ok, william. we have a lot on the table there.guest: i mentioned the aristocratic quality of greek life. this is what our caller is pointing out, perhaps the darker side of that aristocratic inclination. it often falls along class lines , and often falls along -- requires an evaluation of criteria that are troubling, and lends itself to a sort of insulation. addressing this is very complicated, because there is a lot here. there is a financial aspect that's important a lot of the

social fraternities, and sororities. on college and university campuses, at someplace like sick mouth epsilon -- sigma alpha epsilon, it's not cheap to be a member of that fraternity. the question of what's done with that money, when it's being used for windows dues -- when those dues can be a huge chunk of change on top of university tuition to begin with. that's a serious question. there are also other criteria that may not have anything to do with class, but could be equally disturbing.

sororities in particular are often guilty of evaluating based on body image, based on clothing. these are the sorts of things we have to make a very careful judgment about, it's not easy to do that. finally, you see a hierarchy of fraternities and sororities on many campuses, so the better heeled fraternities and sororities and up on top. and you have a certain class system that develops. is that natural? artificial? would happen anyways? it's difficult to say. it's intensified by the presence of these organizations, that codify it and formalize that.

but it is also something of a natural tendency to seek out the like. again, this goes back to the point that there are many volumes to be written about the subject. the callers overall point is well taken. host: from ian tuttle's article it's less a matter of animus that history.

host: jack is calling in from davenport, iowa. caller: good morning. i had an incident when i was a graduate student in physics, we were working on experiment. the numbers came imperfect. -- in perfect. too perfect. when he gets to close to cheating, that bothers me. on the other hand, do people

learn more in for turn of these because they get extra coaching from their frat brothers? i think that's a positive. my question is do fraternities maintain a bank of exams or term papers or scientific experiments to give them great advantage? host: ian tuttle. guest: i'm not sure i follow entirely. the network and certainly be advantageous, especially among fraternities and sororities that take their academics fairly seriously. there are those that exist, we talk a lot about the lack of sobriety fraternities. it's certainly not universal. i'm not sure i follow the question. >> you can watch this conversation online in its entirety at c-span.org.

we take you live to the national press club, where margaret hamburg is going to make remarks. >> i'm delighted to be joined by my parents and many of my friends and colleagues. this is probably my last formal address as commissioner. i thought it would be a nice opportunity for me to reflect a bit on what i have learned about this agency, and what i really want to communicate to you is how firmly i believe, now more than ever, that this is an agency that is absolutely essential to the lives and health of every american, every day. i think it's hard to overstate, really the unique and vital importance of this agency for all of us. i confess i didn't arrive at the fda with a fully formed

perspective. i said yes to the job a little early. i didn't appreciate the vast scope of fda until i was actually ensconced in the job. it still amazes me that the products that we regulate account for somewhere between $.20 and $.25 of every dollar the consumers spend in this country. the fda is responsible for promoting and protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs vaccines, biological products. medical devices, the safety of most of the food supply, the blood supply, and other tissue products, cosmetics, and products that emit radiation. most recently, fda is responsible for regulating the manufacturing marketing and distribution of tobacco products. some things might surprise you about some of the products that we regulate. ranging from things like bionic

eyes and replacement body parts that are made by 3-d printers. to the use of medicinal leeches that was one that surprised me. we oversee the safety of the food the dignitaries needs at government events, like the state of the union, i just learned last week that we are responsible for regulating the waste that is discarded from moving trains. so you can see that wherever you are, the fda is working for you. but is not just the diversity of the products that we oversee that someone might find surprising. it's the way that we bring our enormous expertise to bear. in this age of skepticism about government, it's easy to imagine fda regulators simply as bureaucrats focused on a narrow set of responsibilities. yet nothing could be farther from the truth. what a remarkable group of

physicians scientists, lawyers policy analysts, and other professionals and support staff committed to helping people get the products that they need and count on. i am so happy that some of those fda employees are here with us today. i also was really very struck by the fact that fda employees do far more than just use their knowledge and expertise to review applications or investigate safety concerns. they also undertake vital research to advance medical product innovation and improve food safety. for example, scientists made a crucial contribution to the meningitis vaccine by developing a needed conjugation technology. this vaccine has now protected more than 217 million people from what was a deadly killer across the so-called meningitis belt in sub-saharan africa.

fda's food scientists help develop sophisticated genome sequencing technologies to more rapidly identify and stop foodborne outbreaks. during the gulf oil spill, i was surprised but very grateful when another team of fda scientists developed a new laboratory technique that significantly accelerated the testing process that was necessary for detecting certain oil related chemicals in the seafood itself. that enabled the fda and the state to open up the gulf waters to fishing much more rapidly, it also meant that the rather agitated congressional gulf delegation stopped calling me all the time. so that was really a worthy undertaking. it was also a surprise to me as the commissioner that during that time, i was ordered by the white house twice to go to new orleans and eight seafood.

to show that it was safe. -- and eat seafood it to show that it was safe. there are some hardship duties in this job. i want to focus on a few key issues today, issues that i have really been intent to work on since i began, and i believe have really made an important difference in strengthening and reaffirming fda's critical role in american society. i think that most would probably agree that i came to fda at a time when the agency faced considerable difficulties and uncertainties. a series of visible foodborne outbreaks that resulted in disease, nationwide anxiety, and economic disruption. several drug safety crises had eroded public confidence. at the same time, fda was facing serious threats, budgets were signing with economic crisis. a chronic underfunding had already stretched the agency thin in many critical areas and

jeopardize our ability to keep up with inspectional demand, product reviews, and the evolving science and cutting-edge biomedical products at the very time that scientific and technological discoveries were revolutionizing medical products. fda's challenges were exacerbated by the increasingly global marketplace for the products that we regulate. the importance of fda related products were growing dramatically. there was a series of serious episodes associated with adulterated products coming from overseas, most notably the imports from china obtained heffron, and the melamine laced dairy products and pet foods that cause deaths and serious illness. these effects, and a constant negative drumbeat from our friends in the media combined with the congressional criticism took a toll. public trust was flagging. it was clear there was so much good work going on.

as i took stock of the agency, its vast responsibilities and it's enormously talented and committed workforce, it was clear that fda was at a crossroads. decisions made then would matter in fundamental ways and for a very long time. if fda was truly to fill its mission in the modern era, this was a critical time to reposition in several fairly fundamental ways. to do this, i focused on three priority areas. increasing public engagement accountability, and partnership reinvigorating our scientific base by advancing regulatory science, and underscoring the need for science-based decision-making, and scientific integrity as the foundation for all that we do. lastly addressing the challenges of globalization, and it's huge implications for health, safety, and security in the products we regulate. six years later, thanks to an

extraordinary leadership team at the fda and all of the dedicated employees, i think we've seen enormous progress and really important advances. we renewed, expanded, and refined our mission and activities, in important and powerful ways. notably as well, congress has given us important new authorities to regulate cigarettes and other tobacco products, to transform our nation's food safety system with a new function -- new focus on prevention, and to use more flexible and streamlined approach is bring exciting new medical products to patients in record time. to be effective, fda must do its vital work with input from stakeholders and with the trust and confidence of the public. that is why it was imperative to increase transparency, enhance stakeholder engagement, and strengthen partnerships across sectors, disciplines, and components of government. i really think we have. soon after i arrived at fda, we watched an agencywide effort to

make useful, understandable information about the fda more readily available to our stakeholders. this transparency initiative brought greater clarity and understanding as to what we do how we do it, and why for the general public, for industry, for patient and consumer groups, and for other key stakeholders. we also worked to increase collaborative efforts, including establishing many important public private partnerships. we enhance our communications, including listening sessions leaders, experts, and advocates seeking ideas and feedback as well as a focus on patient centered medicine. which involves holding dozens and dozens of public meeting with patient advocacy groups for input on specific diseases. with stronger stakeholder engagement, there has been much better information sharing, more predict ability, and ultimately a better process and product for the people we serve.

my second priority, science, really builds on and reinforces the efforts just mentioned. as a science-based revelatory agency, our credibility and success depends on our ability to deliver on the promise of science through smart data-driven decisions that benefit patients and consumers. smart regulation also requires the ability to respond to changing situations, new information, and new challenges. we cannot have a one-size-fits-all approach, but we always must bring the best science to bear. it requires that we advance regulatory science. the knowledge and tools necessary for the meaningful and timely review of products for safety, efficacy, quality, and performance. and to inform him more efficient product of element process as well. building on greater understanding of the underlying mechanisms of disease and human biology, a robust field of migratory science can help us

leverage opportunities for innovation and more quickly bridge the gap between scientific discovery in the real-world products that will make a difference in people's lives. advancing regulatory science has been a huge priority, not just within the walls of fda, but as an active, dynamic field of scientific research we are continually working to find new and better ways of doing things. to seize the opportunities of existing science and technology, and to work with industry and our scientific partners in academia and government in a collaborative way to discover and apply new regulatory tools. but what is this really mean? -- what does this really mean? we've taken critical actions that will improve the safety of food americans consume for years to calm. importantly, the development of science-based standards to create a food safety system focus on preventing foodborne illness has been key, thanks to

the passage of the food safety modernization act as well as new tools to help us in the detection and rapid response to outbreaks, as i mentioned earlier. i we've taken significant steps to make americans make more informed and helpful food choices, including working to reduce trans fats in processed foods, more clearly defining when they could foods and other foods can be labeled gluten-free, updating nutrition labels based on current science and finalized new rules to make calorie information available on chain restaurant menus and vending machines. some of you may be asking where is the science there? believe me, and my deputy for foods no, these areas are based on sound and current nutrition science, and involve some very complicated analyses. turning now to the medical product in maine, we are

pursuing such things as enhancing the use of pharmaceuticals and qualified biomarkers, developing innovative critical trial designs which enable critical studies to be -- clinical studies to be more effective. and to effectively mine large databases to learn more about the issues. as well as such things as how can we identify populations of responders to a given treatment based on certain indicators. these efforts matter in our ability to swiftly and shortly review product applications that come before us. they are also essential for reducing the time and cost and increasing the likelihood of success in the product development process itself. in the ecosystem for biomedical product development, fda plays a critical role. because we more fully understand what it takes to translate a

good idea into a product with demonstrated safety, efficacy, and quality. and a product that can be scaled up and reliably manufactured. simply waiting until we see what comes through our doors cannot be the going model. fda is uniquely situated to examine important unmet medical and public health needs, and how they match up with what's actually in the development pipeline. indeed, a growing part of our focus in recent years has been to try and identify what is in the development pipeline provide guidance and incentives to address gaps and to accelerate progress, and to foster the kind of innovation that will make a real difference for patients. also, we've seen how early in continuing engagement between the fda and researchers in the product development plan makes a huge difference in streamlining the process and making sure that the right questions get asked and answered from the very

beginning. as you may know, we have now in place a number of expedited review programs that help to speed the development and availability of medical products that treat serious diseases. for prescription drugs, we have fast-track, priority review, accelerated approval, and now thanks to recent legislation, we have the breakthrough therapy designation. we are seeing both development and review times increased significantly with exciting new therapies entering the marketplace much sooner for the patients who need them. last year we approve the most new drugs in almost 20 years. and more orphan drugs than ever before. 41% of these new drugs were first in class products resulting in a breathtaking array of truly innovative new therapies for patients, and the majority of these new drugs were approved using some kind of expedited pathway.

today, contrary to what many would say fda approved drugs faster on average than all other advanced nations, and the vast majority of the time, the u.s. is the first country in the world to approve important and novel medicines. and substantial improvements are being made in the efficiency of medical devices used as well. moreover, we have accomplished this while remaining the world's gold standard for safety and effectiveness. yet we all recognize that despite the successes, too many diseases still await treatments and cures. serious public health needs such as treatments for all timers disease -- all timers disease -- alzheimer disease are not being met. people suggest that fda's authority and procedures be found mentally reconsidered. i strongly disagree.

in actuality, regulation, when done right, is not a roadblock. it's the actual pathway to achieve meaningful and lasting innovation. smart, science-based regulation this instilling consumer confidence in products and treatments, it levels the playing field for businesses. it decreases the threat of litigation. it prevents recalls that threaten industry reputation and consumer trust. not to mention levying huge preventable costs on individual companies and in fact, entire industries. and it spurs industry to excellence. the fact is, when done right smart regulation allows us to deliver on the promise of science in the service of patients, consumers, and yes even industry. it is foolish and dangerous to believe that reducing regulatory standards will make new treatment intervention appear if the science is not there.

al timers -- alzheimer's disease is a good example. i've heard comments that something must be wrong at fda because we are not approving as many drugs for alzheimer's disease as we are as cancer. but the reality is that -- is not the problem of unnecessary hurdles, but rather for the need of medical research to increase our understanding of the underlying disease process, and natural history of the disease and where are the best targets for therapeutic development. we are working closely with the all timers disease research committee -- the all timers disease -- the research community. we hope that in fact we will see meaningful progress soon. of course, there are sometimes tensions between moving new potentially promising products quickly out into the marketplace and making sure that they have

inadequately studied. as fda commissioner, i have been surprised by how many people ask whether i favor safety renovation. in fact, mi confirmation hearing, now quite a while back, i was really, i guess a bit of an unknown commodity to both the consumer and patient groups, and industry. they were trying to figure out what perspective i would bring to this new position. i was surprised to learn that someone supposedly went through and counted how many times during the course of the hearing i said safety and how many times i said innovation. this was supposed to be a measure of whether i was going to be consumer friendly, or industry friendly. i'm told it was actually about equal. i never went back to actually check. i certainly don't believe that the two are mutually exclusive. why should we have to choose protecting the public health

while encouraging, not discouraging, innovation must be the goal? for us at fda, it is. innovation is only meaningful as it makes a real difference a positive difference in the lives of patients and consumers. that's why we must have standards and science to assess the benefit and risks. when comes to the treatment of disease, we must understand the broader context of use, the nature of that specific disease or condition, the other treatment options, and such things. we must also better understand the patients experience of the disease and its treatment, their perception of the risks and benefits, and of course, their willingness to accept risk. the balancing of risks and benefits is absolutely fundamental to the fda's role. it's always a challenge. we joke at the fda that we have only two approval speeds, too fast and too slow.

we are perceived to approve allies to quickly when a significant safety is identified once the product is in widespread use. on the other hand, we are to slow when a drug that has undergone a lengthy development and review is finally approved and provide the real therapeutic benefits. it's a hard task, but the challenge for fda scientists is to strike the right regulatory balance. i also want to speak briefly about the importance of striking the right balance between fact access and good science. in a race for the newest treatment, we must remember that innovation doesn't matter if the product doesn't work. i can't emphasize enough the critical need to maintain the standards of safety and effectiveness for medical products in this country. it wasn't that long ago that companies were allowed to market drugs without proving that they were effective. we've only got to look back at

that time to see the devastating consequences for patients and for medicine. drugs were marketed for thousands of unproven uses. most of them unsupported by adequate research. when in the mid-1950's, congress gave fda authority to require evidence of effectiveness, i will say 80% of the drug uses the companies were promoting turned out to be ineffective. many of them were also dangerous , for example, before companies had to show that their drugs worked, drug companies widely promoted powerful toxic antipsychotics like thorazine for low-level anxiety. and there was little or no incentive to conduct those research is necessary to find out what were true medical advances. most promotion was based on unscientific studies, or no studies at all. it's important, i think, to

understand that fda strongly supports responsible to medication of scientific information. but we do not support an approach that will harm patients or undercut the incentives for the necessary studies to be done to prove that a specific use of a drug product is both safe and effective. history has shown that patients have been harmed when physician reliance on preliminary or incomplete scientific information regarding unproven uses. history is also shown the enormous patient benefits that results when i sponsor conducts rigorous clinical studies and demonstrates that a promising medical products is in fact safe and effective in treating a serious disease or condition. fda's objectives, to strike the right balance between respecting the usefulness of communicating scientific data in certain circumstances on the one hand, and preventing harm to the public on the other.

we must not forget that the great leaves forwarded evidence-based -- leaps forward with evidence-based methods after a series of disasters involving unsafe and ineffective medical products. the standards have boosted the confidence that americans place on medical products, the world places on the american medical byproduct industry. we must move forward, not backward as a nation. and embrace the opportunities of cutting-edge medical advances and the promises they hold for public health. i want to talk about one other important issue, it's been a priority globalization. when fda was first established are related industries were predominantly local and the volume of imported products was very low. today, however, other nations

increasingly produce in whole or in part, the food and medical products that american consumers and patients use in their daily lives. nearly 40% of finish drugs americans consume today are made elsewhere, and 80% of the active pharmaceuticals in those drugs are manufactured outside our borders. for the food supply, the numbers are equally startling. more than 85% of seafood that the new here comes from other countries. about 50% of our fresh food and 20% of our fresh vegetables, and these changing dynamics off lucy -- obviously introduce new complexities, new risks for american consumers, as these products follow increasingly complex global supply chains to get to your table. in your kitchen cupboard. we can no longer rely on simple inspections at the border to track the products that are coming through. the volume has quadrupled over the last decade. we have introduced new high-tech

risk-based screening systems of the borders to allow us to target on the most vulnerable commodities, the ones with the highest risk. we really have to step beyond our borders to the places where these products are being manufactured. processed, distributed. that has caused us to have to undertake a whole new shift in how we do business. we now have foreign outposts around the world to be a hub for inspections and for collaboration. with industry counterpart regulators, and other stakeholders. we are working closely with counterpart regulatory authorities to harmonize standards, to share information and in fact, to share the workload of inspections and assessments. of the products that we are all struggling to regulate in a globalized world.

we are working together with other organizations and nations, to try and actually build regulatory capacity in many of these countries with very immature systems, but where an increasing volume of products are coming. and being consumed by americans who expect the same standards in the products they are taking wherever they had come from in the world. so that has been a major focus of time and attention. i think it represents a huge and underrecognized area that challenges health safety and security in our nation. so i think that, though i got lots more that i want to talk about, i think that i have gotten the indication that i ought to be winding down. so with that, let me just make a couple of points. one is that fda is a unique and essential agency.

that has a set of roles and responsibilities that are not done by anyone else. if we can't do her job and do it well, there is nobody else to backstop behind it. moreover, we are regulating products that are so important to each and every one of us every day and to the health of our nation, our nation's economy, and in fact, our global economic competitiveness. as i look forward, i worry, fda has constantly been underfunded with responsibilities that outstrip the resources we get to do our job. if you look at what cost every american in this country to support the services of fda believe it or not it's eight dollars for americans for a year. i suspect some of you may spend more than that starbucks later this afternoon, and yes, we regulate starbucks. [laughter]

as i stand here, not only concluding my remarks, but concluding my tenure there is seen as fda commissioner, i really am proud to be able to tell you that fda is a stronger, more engaged, more effective agency, better positioned for the challenges of the 21st century. we are an organization that embraces smart science driven regulation, we are an organization that understands in the modern world the importance of partnership, we have a wonderful mission and an extraordinary group of employees . we have the challenges before us, and we do need your help and support so, while i will not be present any longer, i do want to leave you with this fact that the fda as a public health agency essential to the health of all of you, we need to

strengthen it, rather than weekend or undermine it. and to do so will require support and partnership of all of our stakeholders, and every american who uses fda regulate products is a stakeholder. i look forward to watching that vital collaboration amongst all of the stakeholders, just seeing the work of this relatively small in size, but truly mighty in purpose agency, be both appreciated and supported. thank you. [applause] >> thank you, dr. hamburg. you mention striking the right balance. when it comes to approval of products and devices, and from the experience of your tenure

what percentage of the time would you say that fda got it right, and what percentage of the time did you realize that we didn't do our job there, and maybe we should not have let that one out? dr. hamburg: that is a very hard question to answer, and to quantify would be dangerous task. one of the things that's important to understand is that we are always having to make decisions with partial information. because when you are doing the study before it drugs actually approved, you can learn a lot. and if the drug really works and really reflects a good match between the target of the drug and the underlying mechanism of the disease, you will know it quickly as the decision would be obvious. with many things that don't work quite as well, it would be almost impossible to know

everything about the drug. then even the things that actually are extremely effective, you still can't know everything about them. in the context of a preapproval developments. it's when they go out into the marketplace and they are used by many more people and are used by people with other coexisting diseases and taking other medications etc. that you begin to learn a whole lot more. that's why fda has a lifespan approach to the regulation of drugs. we continue to monitor drugs after they have been approved both really call post-market surveillance and sometimes by requiring those market studies to collect more information. in my view, people are quick to jump on us if a safety issue emerges, in the post-market setting. they think it's a failure of the system, someone had to admit a mistake, but i think we know that everything has risks, and

that the nature of the process is that some of those risks will emerge when many more people are taking the drug, and it's more complex settings. so i think that when we can detect it early, and make the determination about how to address it, whether we need to change the indications for use whether we need to actually recall it from the market, or whether we need to provide additional warnings, all of those things are possible. in all of those things are part of the comprehensive regulatory process. >> you mention several things that you are proud of about the agency, what would you consider the number one contribution that you have been able to make to public health in your tenure? what is the one thing he would talk about couple years down the road when you're talking about your service, that one thing you are most excited about. ? dr. hamburg: that's an

impossible question, number one. there many things in many different arenas given the scope of our responsibilities, it's unfair to even ask. [laughter] dr. hamburg: you think about the many different ways that you can answer the question also. if you mean in terms of potential impact on burden of disease, i would say we hadn't realize the potential yet. but the new authority we had to regulate tobacco clearly is historic and transformative. tobacco products remain the leading cause of preventable death in the country. and frankly around the world. and with the new tools we have over time, we will be able to make a profound impact on health and well-being in this country. and as regulatory authority, a

fairly unique regulatory responsibility over tobacco, we also i think are showing the way for many other countries around the world. and the global burden of tobacco-related disease. >> a couple of different questions on what you think of the 21st century cures initiative in congress to overhaul health care industry regulations? dr. hamburg: i think we all can agree that this is a critical time to really look at what can be done to really leverage the opportunities in science and technology today to ensure that we are developing the safest best, most innovative and effective medical products. for people who need them. that's the goal of 12 first century cures. we are sort of in a golden age for this undertaking. we want to make sure that all of the parts of the biomedical

products ecosystem are aligned towards that goal. i do think it needs to be approached in a very thoughtful and careful way. because many of the things that need to be done perhaps are not best achieved through legislation. i think for us, there certainly concerns about issues that i touched on in my remarks, of the misperception that you might be able to speed innovation by lowering standards for safety and efficacy. we think that would be a terrible mistake and ultimately would not just damage patients, but would damage industry as well. we also are concerned that through this process, we might be given what we call in washington unfunded mandates, or we would be asked to take on a set of new tasks, but there wouldn't be adequate resources to go with it.

that i think would not only be difficult for that specific activity, but would have ripple effects on other important regulatory activities are really matter to patients and consumers. >> what if any steps is fda taking to ensure treatment and labeling of nutrition's in vitamins and nutritional supplements given recent findings on walmart shelves? dr. hamburg: we have authority to regulate dietary supplements. in a limited set of activities many people in this country think that the fda regulates dietary supplements in the same way that we regulate prescription drugs, there's a preapproval process. but we do not. we oversee and have the authority to ensure good manufacturing practices at their

plants, there's a requirement that they report serious adverse events to us, and we do regulate claims that they make, and we find a product that has been approved drugs, for example, that shouldn't be there steroid or a viagra like compound, the frequency show up in dietary supplements. then we will take action. i'm not familiar with the specific walmart case, i will have to defer. >> arabin concern raised by -- there have been concerned that the medical device approval process is too lax. how do you feel about the process now, and have you felt political pressure to accelerate product approvals, and what changes need to happen to that product approval process? dr. hamburg: medical devices

have a different regulate tory pathway than drugs. for some of the points i was talking about, in terms of the different perspectives that people have on fda, too fast or too slow, too lax or too stringent, applies with medical devices. the majority of medical devices that fda oversees are what are called 5, 10 kay's, not the highest with devices with the middle category of devices. there are very limited requirements for new data to be generated as a part of that approval process. you need to demonstrate that your product is similar to an existing product in the marketplace, using a predicate mechanism and some people find that just totally lax and inadequate. to assess a changing device

array over time. others think it's more than enough, they would like to see even the standard that currently exists relaxed a bit. it's one i have been fascinated with during my tenure as commissioner to see the differing responses and i think that we need to continue to look at how we regulate devices because the world of devices is getting increasingly complex on one end and then there's a set of other devices that really don't need much attention. i think this is an area where i don't know that the u.s. has gotten a completely right, i do know that the european union has gotten a completely right, i think it's an area that we need to continue to learn more about and i think that we are

encouraged by some of the activities, partly through public-private partnerships that have developed, to look at innovative strategies to do research that's necessary to better assess devices through a recent new requirement for you need device identifiers on devices, so we would be able to track devices and their use in the post-market setting more efficiently. and learn a lot more about risks and benefits. i think it's a dynamic area. >> had a few questions come in on the relationship between the agency and it those the regulates. this questioner says that within the ranks of the fda, there are many scientists and administrators who have served at the agency for decades, and one of the criticisms is that

the leaders become too cozy with industry after working for years with the same officials, well fda obviously strives to retain its best staffers, is the risk that staffers can overstay their welcome and this problem creeps in? dr. hamburg: again, this is one of those areas where different people have very different perspectives. some people believe that there are lifers at the fda that have no use for industry, and are always skeptical. and then there are others who worry about the issue you were describing. what i would say is my experience at the fda, which is now almost six years, is that the employees who work there have just remarkable commitments to their jobs, and the highest integrity, scientific and personal integrity, we obviously

operate in a framework where there are very clear conflict of interest rules. very clear requirements about how certain kinds of interactions are structured, and i think that we need to work in partnership with industry because we are regulating the product that they make, and we need to understand those products. we need to have a full and open exchange of information. in many instances, there is great value in having industry, academia, and government actually worked together in shaping research in critical areas. i think people sometimes get worried about that. but we do it in a way that clearly defines us as free competitive research not a collaboration where there is a

particular product that's being developed where an fda scientist might be working in the partnership. but it's where information is being developed that can be applied across a whole category of products and help us to advance our knowledge and develop a regulatory tools that are needed to advance our ability to do adequate and full reviews of the products. and to enhance product development. >> you have been a champion of advocating sodium reduction. the majority of your statements reference what pressure benefits of lower sodium consumption. however, some recent studies cited by this questioner including one by the iom have suggested that low sodium consumption for healthy individuals can lead to

significant health problems. another article found that for healthy people, there is no or very minimal blood pressure impact from sodium reduction. the questioner is saying that the agency needs to reevaluate what it says on sodium and is there any examination of shifting the view? dr. hamburg: this is been a topic of ongoing discussion, i think that clearly there have been some recent studies that have raised some questions there have been individuals who have obviously been representing that position over time. i think the body of evidence does really demonstrate a linkage between sodium in the diet and negative health consequences. and that americans' diets on average contain a very large amount of sodium.

most of that sodium is in processed foods where we as individuals consumers really can't control our exposures in terms of what is in that food, is not the salt shaker where you can control it it's what you are eating. so we feel that we are providing very important information to consumers through things like the nutrition facts label, which enables you to know what is in the product that you are eating. and we do things that there is clearly, a very positive health benefit by trying to bring down sodium levels in the american public. >> got a couple of questions on bio similar scum i will try to combine them because we are running short on time. when questioner wants to know how you envision this new area

of copycat versions of biotechnology drugs playing out in the u.s. marketplace, the other wants to know if devices such as generics in bio similars may actually discourage the development of lower-cost options for the public? dr. hamburg: bio similars are biological molecules that are similar to existing biological therapeutics that are innovative drugs in the marketplace. they have a parallel relationship to generic drugs and innovative drugs. they are much more complicated molecules in terms of their size and how you make them. in the human response to them. it's a much more complex process than just generic chemical tablets. we've only just recently approved her first bio similar

which was an exciting event for us. the pathway for bio similars actually is relatively new at the fda. it was part of the health care reform act, the aca actually. one of a few things for fda to was embedded in that larger piece of legislation. we imagine that these drugs will be available to the public at much lower cost than the innovative biologics, which are very, very important drugs in medical practice, they make huge difference in the lives of many patients, but very very costly. it remains to be seen whether some of the most optimistic estimates of cost savings will really be true, but if we can help make important therapeutics available in a more accessible

way, i think overall in terms of the american health care system, that would be a huge benefit and the fda role is to assure that these bio similars can be used in these patients in a manner that is safe and effective. >> could you update us on the current listeria problem? we are interested in any specific foods or brands involved in recalls. dr. hamburg: we have a couple of listeria problems. we have listeria in bluebell creameries ice cream, which in resulted in several deaths in a kansas hospital. and there was a listeria outbreak in spinach but i when companies did a voluntary recall after finding listeria. i don't know that there's much more it i can say other than

it's a powerful reminder that foodborne illness is very real in this country, and it can be low-grade, where you get sick and have a few days off from work, one in six americans suffer from foodborne illness every year. but it also does results in many, many hospitalizations and deaths each year in this country. we are in the midst of implement in the food safety modernization act, which is a historic opportunity to transform her food safety system from one that is reactive, where you respond after albert occurs, to one that puts the emphasis on prevention, and understanding where the points of vulnerability in the lifespan of the product are, and how can you shore up those risks so we can prevent problems from occurring in the first place.

i hope that we will come as we implement the food safety modernization act, be able to report fewer listeria and other foodborne illnesses, but in the meantime, i think one of the other things that striking about listeria outbreak so we've been seeing is that we are seeing listeria in certain food products where we hadn't seen it before. so it also is a reminder that microbes can be unpredictable they can take up new homes, and that we have to always come back to the best strategies for food handling and hygiene and the implementation of the food safety modernization act to prevent problems from occurring. >> i will ask you one more question. i wanted to remind our audience of our upcoming speakers. on tuesday, john cosper and will speak to us. on april 7, a best-selling author and outspoken critic of radical islam will address a

luncheon. on april 16, ban ki-moon secretary general of the united nations will speak. second, i would like to present you with your national press club mug, which is perfect for enjoying fda approved liquids and. [laughter] dr. hamburg: excellent. we do regulate some forms of ceramics as well. [laughter] >> wouldn't you know it. the final question as you were named one of the world's 100 most powerful women by forbes and 2014. what do you think our country can do to encourage more young women to pursue careers in science, technology, engineering, and math? in other words, to follow in your own footsteps. you have less than two minutes to answer. dr. hamburg: i think it's really important, we need to start early, we need to have exciting engaged, knowledgeable teachers

in our teachers -- in our children's schools. have to help with mentoring career pathways, and we have to make sure that there are good jobs for women at the fda. we have a very strong representation of women in our scientific and leadership teams. i have been proud to be at the helm. >> ladies and tillman, join me in thanking dr. margaret hamburg -- ladies and gentlemen, join me in thanking dr. margaret hamburg. [laughter] [applause] >> i would also like to thank the national press club staff including its journalism institute and broadcast center for organizing today's event.

if you would like a copy of today's program, or to learn more about the national press club, go to our website press.org. thank you very much. we're adjourned. [captions copyright national cable satellite corp. 2015]