recognizing that fda can't do this by itself.here's some 50 specific mandates, just as an example, to connect with other agencies to coordinate and to collaborate in various aspects of implementing the law. we are collaborating with foreign governments and build capacity there. but also to collaborate again with the private sector to figure out a way we make the public role of setting standards and creating accountability work with the industry responsibility. how do we get the right guidance out there over time to ensure that the expectations are clearly defined about what preventive controls mean in particular circumstances. and of course, collaboration and partnership with the consumer community. this is all about meeting the public's high expectations for the safety of the food supply and we look forward to both the rule-making process and beyond and benefitting from really active engagement with the consumer community. that's broad brush, how we're approaching implementation. you'll judge for yourself when we put out proposa

the broader question, though, abstracts from the fda in which i agree that the fda has in fact made innovation in the drug industry much harder, the broader question i think is how well we can map this slowdown across a range of formerly innovative sectors to regulatory sclerosis, and i am not sure that mapping is necessarily there. i am not saying it is not. some things we want to know. one is, well, we do have a couple of substantial exceptions and, boy, they're big exceptions. it is a pretty bleak picture that peter painted but if you look at actually just the computer and internet world and the financial world, there is a heck of a lot of value and wealth created here that was unimaginable 40 years ago in communications but also in terms of the things that computer technology does in all of those other industries. we have had productivity gains in lots of industries that seem like they're not innovative industries, whether it is the steel industry or anything else largely because we have had computer innovation in those industries. we're innovating and maybe innovating in other areas, too,

the fda has been without a fullrs worely on the fda to permanent . >> i see i've >> absolutely.120,000 workers. it's it's an extremely important agency. do you think it's unconchenable our legislature has not solve that problem? >> we have to understand that there is some really good career civil servants who probably are making sure that agencyre >>> are drug manufacturers raising the price in the very clutch at the end? >> we do see some raising the price in the 6-9 months before the patent expires. >> does that defeat the alleged massive savings to the consumer from ger nark drugs? >> not at all. the opportunity is enormous. we know that if the country used anti-inflammatoriy drugs the way doctors and kaiser did rather than celebrex and vioxx, the country would have saved 5 billion dollars. >> i'm sorry we are out of time dr. sharon levine. anncr: creating a financial safety net can seem like an impossible goal. complicated. intimidating. something other people get to do. but on you take the first step. you'll find there's nothing standing in your way. metlife. i can do this.

it's a major focus of effort at fda. ly mention one other document for further homework for those interested. you -- many of you are probably aware of the report issued in 2010 entitled "enhancing food safety." i would encourage you to read that document. the last thing i'll say about this whole effort, just to demonstrate our commitment to it, is we have created a new position and eventually there will be an office of resource planning and strategic management. and this is going to be the focal point for the foods program, the veterinary medicine program broadly. this is where we'll do the risk analytics. data integration to do priority setting. this is where we'll do the planning of resources, budget formulation, and we'll have strategic capacity to institutionalize the capacity to work in this new way. so i go through all of this just to recognize that there's a big picture here that these rules are part of. it involves a lot of system building, both within our agency and in the food system we regulate. it's a long-te

board brands of jerky treats imported from china. >> the fda has done a fairly poor job of notifying the consumers >> the veterinarian says the fda has never named brands or issued a recall but it has none of a problem with some of the streets since 2007. the fda is actively investigating reports of chicken turkey but scientists have not been able to determine a definitive cause for the illness, nor has a contaminant in found >> you cannot deny the link >> in majority of the brands imported from china are still being sold. the attorney says based on the number of complaints, store should consider pulling them >> it is not good for big business to disregard safety >> pet smart says it has no plans to poll watch future cast. by tomorrow morning's commute in the far reaches of the north bay we start to see a hint of light precipitation but as we gradually start to send it falls apart and diminishes any kind of rain that we do see around the central bay by about one showers will not cancel the giants afternoon baseball game. anywhere from about of the 107 in. of rain to a quarter inch of

but in 1976 the fda allowed it over the counter.ou have to do is show the pharmacist an i.d., and there's a limit on how much you can buy. but meth makers easily use straw buyers they call smurfers to skirt the law. if we spent $15 for these two boxes at the store, how much could that get you on the street moneywise? >> reporter: meth makers pay big bucks. >> this box here is $100. right here, you're holding a $100 bill. >> reporter: but in this state where meth is deeply entrenched, grellner believes he can roll back the tide. >> if you return pseudoephedrine to a prescription drug, pseudoephedrine meth labs go away. they just end. >> three, two, one, play it. >> reporter: for years he's used the media to promote his cause. >> what we're trying to do is put a genie back in the bottle. >> reporter: but he keeps losing to a powerful opponent. >> how many years have i been trying this? '98. '99. 2012. what are we, o for 14 years. >> he's very passionate on this. and our paths cross multiple times. and very committed to it. >> reporter

it's an agenda that i will say is putting enormous pressure on fda's staff, on fda's management. i think i really appreciate what carol said about the effort that folks have made. it's been extraordinary effort by the people working at fda to develop these proposals while also engage anything the outreach we've done, while also operating the program we've got in place today every day. they've been incredibly resilient, incredibly thoughtful, and i just can't say enough about the effort that they've made. just to flush out the picture a little bit more about why we're looking to manage differently, i don't have to remind folks in this room that the job at fda isn't just limited to implementing the food modernization act. we have a set of issues that we have to address. we, of course, regulate dietary supplements and continuing challenges there in that part of the food system. food labeling, including nutrition labeling and claims, we're looking to update the nutrition facts panel. we're implementing the menu labeling law, and, again, looking to improve information that consumers h

it is a few hours ago the fda recommended approval of the first drug to prevent hiv. dr. john the pool reports said. scientists play a key role in this milestone. >>> the drug is called to buy that and is currently used as part of a cocktail of drugs to treat patients with hiv. the fda panel's recommendation to dramatically expand its use to include healthy people poorer risk for contracting hiv. >>> dr. robert grant of the university of california san francisco led the research. adding this is a huge milestone we're in an era now for the first time when we can foresee the end of the aids epidemic. >>> it is any more than 1200 help the game and took to nevada the drug reduced their risk of hiv infection by 44 percent. however many participants failed to take the pill every day. for those who took it faithfully protection from hiv was much greater. >>> among those who actually use the drug at a regular basis the protection was much higher. over 90% reduction. ends the rate of hiv infections. it works by blocking the ability of a steady to multiplied. dick weis the fda pane

instead of responding to contamination into the food supply, fda is actively trying to prevent it. >>t has given us an additional tool to make you optimistic. i think we'll have other levels of control. over the last ten years we imported food, it's than% but my staff has not. >> barbara says the agency needs to be smarter in how it inspects food. >> what we're trying to do is put limited resources at the most important areas in food supply. >> dan: that means ranking countries that i am post food to the united states and focusing on those with the worse records. >> if they deny the inspection we would deny the entry into the country. >> eric is with the washington, d.c. pew research center. he says strides are being made the fda will need more money to implement everything required in the act. >> we are concerned that fda won't be able to check all those imports, not be able to ensure that domestic factories are regularly inspected. will not be able to issue the new science based standards to protect things like produce and processed foods to make sure they are safe. >> kristen: a un

because of the fda. it's the fda's shining hour. francis kelsey, a pharmacologist and physician at the fda looked at the tests and said the tests weren't done correctly, i am not convinced the drug is safe. the drug maker said we are going to sue the fda, if you don't approve this drug, we're going to sue you. everybody else is selling it, why won't you? and the fda held firm and said, no, we're not going to gamble with the lives of americans. and, of course, americans were saved from this tragedy. but what's happened today? the babe on the right is a picture of one whose mother was given the lid hide. it's not being be tested in the west. this is a horrible, ethical misstep. it's not only that these people are being asked to assume all the risks and be none of the benefits of the testing, because the testing is for conditions like multiple myeloma and leprosy, and what they have said to me is, well, harriet, leprosy is rampant in places like brazil and nigeria, so we're doing them a favor. no, we're not. because this drug to treat

the big issue here is, because it falls under supplements, fda is not regulating it. depending on where you get it, you may not get the right dose, 600 milligram dose and i think that is the big thing, there is no regulation on this, you may get contamination with those. >> eric: dr. siegel, if you are taking a statin, should you also take red yeast rice. >> really not for the reason david said. 15% of the time you get a severe muscle ache with a statin that cause you to have to stop it. red yeast rice is interesting. it is actually the coloring we use in peking duck and has been around thousands of years and the problem is, in 2007 the fda said we don't really want those monocolins at a high level... the exact chemical that gives you the statin-like effect. so, in other words, red yeast rice is a lot like statins, especially with the chemicals in there and the fda says we don't want the chemical in there and the annals of internal medicine studied it and found it does lower cholesterol. so what do you do? i found that in patients that are resistant to taking statins,

fda says it can't comment on an ongoing case.meantime, the fda approved claim has been removed from the website. they told us they realized it was inaccurate claim part of a link to an old paper. in 2010 under from the united nations and dozens of disability rights group the department of justice launched an investigation into the center. two years later, no word on their findings. we asked for an update today. they declined to comment other than to say it's ongoing. massachusetts officials have repeatedly tried, failed to shut down the school, which clearly has friends in powerful places or at least powerful lobbyists. last year the state adopted regulations banning the use of skin shocks and other therapies, but they carved out an exemption for students enrolled before 2011. today the state center took the first step in extending the ban. the bill passed. joining me tonight, the bill's sponsor and a professor of child and adolescent psychology who serve ots board of the american academy of child and adolescent psychology. a lot

. >>> the unique way she a woman is pleading for a cancer drug not yet approved by the fda. >>>levinson took the realm today and investors seemed to approve the change. embattled ceo thompson stepped down after controversy erupted over his resume. it stated he had a computer science degree when in fact, he does not. >>> the dow industrials plunged 125 points, nasdaq dropped 31. >>> facebook will reportedly take stopping orders for its ipo tomorrow but even so the price will still go up. facebook has more orders than it needs. the initial public offering is expected on thursday with trading to start on friday. shares are currently priced at 28 to $35 but analysts say they could be bumped up. this has been a big week for mark zuckerberg, he also turned 28 this week. >>> ktvu's lloyd lacuesta is live in san jose where people attended a community meeting and raised concerns about homeless encampments. >> reporter: emotions were raw today about a homeless encampment less than a mile from here. >> who are these people? i mean they are people, i want to know who are they. >> report

. >>> the unique way she a woman is pleading for a cancer drug not yet approved by the fda. >>>levinson took the realm today and investors seemed to approve the change. embattled ceo thompson stepped down after controversy erupted over his resume. it stated he had a computer science degree when in fact, he does not. >>> the dow industrials plunged 125 points, nasdaq dropped 31. >>> facebook will reportedly take stopping orders for its ipo tomorrow but even so the price will still go up. facebook has more orders than it needs. the initial public offering is expected on thursday with trading to start on friday. shares are currently priced at 28 to $35 but analysts say they could be bumped up. this has been a big week for mark zuckerberg, he also turned 28 this week. >>> ktvu's lloyd lacuesta is live in san jose where people attended a community meeting and raised concerns about homeless encampments. >> reporter: emotions were raw today about a homeless encampment less than a mile from here. >> who are these people? i mean they are people, i want to know who are they. >> report

the fda normally follows the panel's advice. final decision is expected by june 15th. >>> all right, we are days away from the seventh annual amgen tour of california. the bike race kicking off in santa rosa before heading to san francisco and santa cruz county. stage three starts tuesday in san jose before wining through contra costa county and finishing through livermore. the racers will make their way through parts of central california before finishing things up down in l.a. on may 20th. >> all right. let's get things over around here. check the morning commute with mike. >> talking about friday, folks, looking at getting off work. and these guys and gals, the first to show the area. 680, sycamore valley. both directions have construction blocking a lane or two on either side, but we don't see any slowing through the san ramon valley. a nice easy drive. watch for that equipment to move closer to 6:00 and i'll watch for slowing then. getting away from the bay bridge. berkeley curve up to university. one, maybe two lanes block

the fda declined to comment when they asked.hey did say the school should not be referring to its skin shock device as fda approved. they also said, "behavior modification techniques involving the use of aversive regulations, including skin shock, are heavily regulated in massachusetts by the massachusetts dds and the massachusetts department of early education and care." what the website doesn't mention is that skin shocks have been banned in massachusetts since last september. the massachusetts health and human services department told us, "the administration filed regulations last year to ban the use of aversive therapies for any student who was not already receiving aversive therapies by order of the probate and family court. as a result, no new behavioral plans with aversive therapies have been put in place since september." in other words, any student who enrolled in judge rodenberg center after 2011 cannot be shocked under the new state guidelines. students who were enrolled before then can still be shocked. a research di

we're going to show you the first fda approved long-term treatment. also, a new idea to get better food on all of our plates. how to make better choices more available to everyone. first, i want to tell you about an incredible experience that i just went through. it began when the scholar henry lou business gates jr., skip, he asked if he would be part of his television series called "finding your roots" on pbs, and i said, sure, absolutely. you see, i was born in michigan, but my parents were born and they grew up in india. like a lot of immigrants, they thought they would never be able to learn their whole family history. that was lost, they thought, in the old country. i always wondered and so i gave professor gates the names of my immediate relatives along with a cheek swab of my dna. here's some of what he found. >> reporter: to dig even deeper, we sent sanjay's cousin to hardwar, located on the ganges river. it's a place of tremendous geonoloical importance to hindus. they come to consult with family prooisz who have recorded their male lynnage

michael roa aprobacion, se espera que la fda se pronuncie al respecto en junio proximo... peticion se basa entruvada Ár la fda para por vn inacio con o droga no comofao que previene por si solo la infeccion... el medicamento ayudarÍa a prevenir las infeccioneslones de nuevas infecciones anualmente ... truvada es un medicamento costoso, la receta para un mes cuesta alrededor de mil 200 dolares... pasamos ahora con el socio de los deportes y un adelanto del segmento deportivo...socio, uni. buenas noches, se viene otra jornada de la mls, dc united esta en houston para enfrentar al dynamo, andy najay nos habla de su nueva posicion y de la inauguracio a nivel local se viene la entrega de uniformea para la copa taca de futbol, elias polio nos cuenta como sera el formato para este torneo. vamos a contarles donde estaran jugando las diferentes ligas del area para este fin de semana. maÑana sabado la liga de veteranos de washington jugara en anacostia park y oxon hill, para el domingo, la liga universal de manassas estara en el parque de splash down, la liga internacional de virgin

the drugmaker said we are going to see the fda. everyone else is selling at pier by while a few clicks the fda held firm. they said no, were not going to gamble lives of americans. and of course americans for safe this tragedy. but what is happening today? the picture on the right is also a picture of the baby with the camellia and he also has a because his mother was given thalidomide. thalidomide is being tested thalidomide is being tested developing world. brazil, nigeria, cuba, other developing world. brazil, nigeria, cuba, other parts of africa. it is not being tested in the west. it's a horrible ethical misstep. it's not only people are being asked to assume all the risk and none of the benefits of the testing because it testiness for conditions for multiple myeloma and the essay. and they said hey, leprosy is rampant in places like wasilla nigeria, so we're doing them a favor. now were not because they strive should treat conditions that will never make its way to these people. they can't afford it and marked the point, phar

i asked the fda, what took so long?research need to reach a certain level, and so we believe that there's now a body of clinical evidence that supports our guidance to manufacturers. >> reporter: parents, you should always ask, do you really need this test? and if you do, is there a different test without the radiation, an mri, an ultrasound, which would provide the same information? and is the machine set to a child's dose? and there is good news. little lucas, his arm was not broken, but he did need that low-dose radiation to confirm it. dr. richard besser, abc news, new york. >> so weird. and it's hard for doctors to tell how much radiation a child is getting because it varies by age and also by the brand of the machine. >> that's right. but i think what's good is under the fda's proposed guidelines, manufacturers of these devices have to provide that specific information on how to minimize radiation exposures for children of different sizes, different ages. radiation for a 6-year-old is very different, i think, radi

i asked the fda what took so long?s have to reach a certain level and we believe there is now a body of clinical evidence that supports our guidance from manufactures. >> reporter: parentist, you should also ask, do you really need this test? if do you, is there a test without the radiation, an mri, an ultrasound, that would provide the same result? and is the machine set to a child's dose? >> richard is here now. concussions, how do you know if you have a concussion without a scan. >> i'm a pediatrician, you can evaluate the kids in the emergency room. you can tell just by their symptoms. by the time they get to the emergency room, they are improving and a c.a.t. scan adds nothing to the care. >> at time, you talk about ad t adults, all of us watching, don't get too many scans. ask which questions again? >> do i really need the test? will it change my care? if i do need the test s there a way to get the same test without radiation, if i have to get a scan, can i have the lowest dose possible. >> the doctor can say, le

they're going to be considering fda reauthorization of a user fee for the fda. also taking up a judicial nomination. that's going to happen at 4:30 with votes scheduled at 5:30. we're going to hear from president obama later on. 4:30 he'll be closing the nato summit in chicago with a news conference. we'll have that live on cspan at 40030. later tonight president obama will be speaking at the commencement ceremony at joplin, missouri. this month marks 1 years since tornadoes killed 160 people including students and staff at the school. we'll have the president's remarks from the high school at 9:15 eastern. >>> thank you, all of you, for being here. i called this hearing of the subcommittee on oversight of government management, federal work force, and the district of columbia to order. i want to welcome our witnesses. aloha and thank you for being here. as chairman of the subcommittee i have held seven, seven oversight hearings that emphasize the need to build a federal government's foreign language skills from developing a foreign language strategy to improvin

about the streets date back to 2007 but since november they have skyrocketed and in six months the fda has reportedly logged over 900 cases of illness or death linked to various brands. brands that we found today on bay area store shelves. >> it is terrible. they should ban those. for sure. >> technically cannot. despite numerous test the fda has yet to find specific talks and responsible for the illnesses and cannot legally recall a product based on complex along the agency provides nothing prevent a company from doing a voluntary recall. so we reach out to stores. despite complaints, they say the chicken jerky is safe to feed as directed, occasionally in small quantities and in separate statements, the companies say they continue to sell the trees because the fda has not identified a contaminants. statements that leaves a pet owners hoping someone does something soon. >> we were fortunate that we caught this in time and that she is still alive. >> and a reminder, if you have a consumer problem ore question: hot line. volunteers are there right now. well, it is a bird, it is a claim,

the fda is proposing machine manufacturers design new ones with specific instructions for kids. there should be special settings for newborns, 1-year-olds, five-year-olds, and preteens. >> and now, your 11 insta- weather plus forecast with chief meteorologist tom tasselmyer. -- tony pann. >> it turned out to be a nice day today, but plenty of sunshine sneaking through the clouds out there. we should be in the low 70's this time of year. we're in the upper 60's. cool air is spilling out of the southern part of canada. the breeze has been picking up between 25 to 30 miles per hour. that should be settling down in the next couple of hours. you can see the weather across the country where the jet stream is and where there is a rich. underneath that, 50's and 60 does this evening. temperatures are in the a.d.'s through the canadian border. -- are in the eighties through the canadian border. tomorrow should still be a bit on the cold side. 63 in westminster. rock hall, 68. and 63 in rising sun. the winds are gusting over 20 miles per hour at the airport. a northwest wind 18-25. the ai

the fda declined to comment when asked.he skin shock device as fda approved. they also said, quote, behavior modification techniques involving the use of aversive interventions are hefley regulated in massachusetts and and what they don't mention is that skin shocks have been banned in massachusetts since last september. the massachusetts health and human services department told us, quote, the administration followed regulations to ban the use of the therapies for any student not receiving aversive therapies by the probate court. no new behavior plans have been put into place since september. in other words, any student who enrolled at the rotenberg center cannot be shocked under the new state guidelines. students who were enrolled before then can still be shocked. we have a research director from the center and a neuroscientist at yale university. kevin, did i mangle your last name? >> a little bit. but that's fine. >> what is it? >> pelfrey. >> okay. what happens in a body when it is shocked like andre. >> sure. from the

the fda, people think it's backed up, it's got too much to do.it regulates a giant part of the economy. why is this organization somewhat akin to the sec? why doesn't the fda -- given how powerful they really are, tens of thousands of people working for it to try to approve as many drugs as possible that we need? >> it's perplexing because it's such an important agency for all of our health, not just drugs, but foods, drugs, cosmetics, everything. yet, we are in the process of passing the fifth user fee agreement. when we submit a new drug for fda to review, we write a very large check to the government. so they have the resources to review this drug to get it to patients on time. >> that's how it works. you think congress would allocate it because we want to be the world leader in drug development. one last question, next big thing in the pipeline that we should be looking for that i can expect you to come on the show if you get approval. anything? >> we have our own long-acting medicine for schizophrenia that goes under the code name of alk 907

despite tests the fda has yet to find a specific tocsin responsible for the illness and cannot recall a product based on complaints alone but they do point out that there is nothing to prevent the company from conducting a voluntary recall so we reached out to various stores that sell the streets. despite the complaints and a sleepy arena says that it is safe to feed as directed occasionally in small quantities and in separate statements both bill monte and pet smart tell us to continue to sell the streets because the fda has not identified a contaminant. statements that the pet owners hoping someone does something soon. >> we were fortunate that we can't this in time >> efta has inspected plants but has not released results. if your dog becomes ill they ask you to immediately report it and save the streets for possible testing. warning signs are increase drinking, your nation, a bomb in diarrhea and lethargy. >> in southern california police shot and killed a mountain lion that wandered into a busy area of santa monica. a janitor spotted him this morning just a few blocks from the be

though i did speak to the fda. and there would be steps. if these companies -- the burden is now on them. if they do not come within the next now 12 days to the fda and they do not tell them that it is, in fact, not a drug, this could be pulled off the market. the work could be done for them. >> great reporting, darren. thank you very much for bringing that to us. >>> coming up on "street signs," can blackberry 10 save research in motion? we're going to debate that and whether or not josh brown's rim pick in the cnbc's stock draft was a bold call or just wishful thinking. with the spark miles card from capital one, thor's couture gets the most rewards of any small business credit card. [ garth ] thor's small business earns double miles on every purchase, every day! here's my spark card. and here's your wool. why settle for less? great businesses deserve the most rewards! the spiked heels are working. wow! who are you wearing? uhhh, his cousin. [ male announcer ] the spark business card from capital one. choose unlimited rewards with double

the industry has not be afraid to let the fda no it they had a problem so we can get in there and work with them to fix it before a results showed up. the fda says the two bills that have been languishing in congress will help to fix the problem. >>> your sink in that sponsors of legislation. >>> if you have some industry life-saving if both parties agreeing and yet it cannot get to vote to a vote i'd never seen a congress where it's more difficult to pass legislation i think you should call the leadership so we did. we set up at the weekly press briefing. the congress is getting ready to move the bill. but i will also last where is the administration? whereas the president and is said to talk to about leadership. >>> the committee process began over a year ago. she's a to soften key most toxic effects. typically things take a long time that's when someone's been a governor in the state to come to congress and ask what's going on. could you notice someone say move along? >>> for small things have happened. it's a step in the right direction. but there is no way that fire anyone else to

the fda is considering the approval of the first over the counter hiv tests.d allow consumers to test themselves at home for the virus that causes aids. it could play an important role in stopping the spread of hiv, but have concerns about its 93% accuracy rate. >>> the other huge development, an fda advisory committee -- the panel recommended approval for healthy people, including gay and bisexual men and heterosexual couples. the fda released a report suggesting scientists believe the drug is safe and effective. the feds are expected to make a final decision by june. justin, director of medical adherence at the clinic joins us. thanks so much for being here. >> thanks for having me. >> start with that home hiv kit. do you think it's a good idea? >> any idea to get more people aware of their status is a good idea. it needs to come along with good information on how to link people to care and good counseling. >> all right, good advice. let's talk about truvada. on the surface, it seems like great news, but we heard there's a downside to this one. what exactly