. >>> we start with the fda, the food and drug administration. thank goodness for the fda. he careful government sciences. they make sure that greedy drug companies don't sell us dangerous drugs or drugs that don't work. one drug company said the drug -- would cure morning sickness in pregnant women and it usually did, but then some women gave birth to children with no arms and legs. this happened in europe, but not america because the fda hadn't yet approved the drug. so thank goodness for the fda protecting us. but the fda grew like a tumor. getting a new drug approved now cost more than a billion dollars and takes up to 15 years. that caution kills people too. the fda once held a news conference and proudly announced this new heart drug will save 14,000 lives a year. jt up at the press conference to ask, excuse me, didn't this also mean you killed 14,000 people last year by delaying its approval? reporters don't ask that because reporters don't think that way. but it absolutely meant that. that year 14,000 americans died because of that delay. regulation can kill too, but

>> screw the fda. i am going doa. >> that decision like it or not is left up to the people in this hospital. >> it's his body. >> why should the government stand in the way? >> there are cases in which individual benefit can be obtained by a drug not approved the fda. that is true. then it is up to the person who wants to gain access to it. >> sometimes people have to go out of the country to get things unfortunately that the fda may not have approved but in not approving it they are often reasons that deal with serious adverse health consequences for people taking the drug that hasn't begone through an approv process. >> let's go to the other side. >> 16-year-old austin and 12-year-old max have a form of muscular dystrophy that leads to muscular degeneration and eventually death. the by's mom heard about an ex p spur -- experimental drug that was going through fda trials that was told max could be in the study but austin could not. after 16 weeks jen could see the drug was working. max can walk. he can

the problem is not with the fda. ready alluded to the fact that what happens more often is the problem rests with the sponsor, the company, the person who or whoever owns the drug not being or not willing to be able to provide that drug for those circumstances. let's focus on that. let's fix that problem and this legislation does not do that. >> stand by, everyone. david and then elizabeth. david, go ahead. >> yeah, what i was going to say is one also has to remember that giving unfettered access to experimental theorapeutics coul potentially damage the opportunity of other patients to be able to get access to that drug when it's approved. if there are very serious side effects that are detected with experimental use of drugs and there's a huge social media campaign around that patient getting the drug. if that patient's death is hastened, that could potentially create a firestorm that might influence fda's approval of that drug. >> yeah. and -- quickly, elizabeth, go ahead. >> one reason why the -- one reason why dru

>> we heard from the fda in the simplest term no.hey basically said to us is in a risk-benefit evaluation they felt that the effect was only modest and therefore they didn't give us approval. >> reporter: the fda denied our request to be interviewed or comment specifically on the drug, but they are denying any allegations of gender bias. >> it is not sexist for the fda not to approve a dug it doesn't >> reporter: some doctors say it was rejected for a simple reason, it's an ineffective drug for a non-existent problem. >> it's a classic marketing technique to first create a problem and then sell a solution. and that's what is going on here. sexual desire varies by person and varies by phase of life, but that doesn't make it a disease. >> reporter: cindy whitehead and sprout pharmaceuticals are appealing the fda's decision. if sprout wins the appeal it could be available as early as next year. it's a ruling women like amanda parish are eagerly waiting for. for "nightline" i'm mara sciavocampo. >> pretty interesting. i'm confused. one i

but tonight there's a new word of caution from the fda. >>> and later, hot wheels. e experiment that started in a toy store now making a difference for a lot of inspirational kids. >>> our health news story tonight will likely be of concern to all of us who take some form of aspirin every day. and those estimates start at somewhere north of 40 million americans. tonight the fda is warning that a daily dose is not for everyone, and taking aspirin needlessly may actually put them at significant risk. our report tonight from nbc's tom costello. >> reporter: for years, thanks in part to heavy advertising, many americans have believed aspirin is just what the doctor ordered to prevent heart disease. but leading doctors have long been concerned about patients without heart disease taking an aspirin a day. >> i think a lot of people think that because it is over the counter, that it has no side effects. and we've often said that if aspirin were invented today, it would actually be much more strictly regulated by the fda. >> reporter: aspirin thins the blood. it also carries

for female sexual dysfunction and denied any allegations of gender bias. >> it is not sexist for the fda to approve a drug that it doesn't believe is effective or safe. >> reporter: some doctors say that the drug was reject ford a very simple reason. an ineve f an ineffective drug for a problem. >> a marketing technique, create the problem and sell the solution. that's what is going on here. sexual destir varies by person and phase of life. that doesn't make it a disease. >> cindy whitehead and sprout pharmaceuticals are appealing. if sprout wins the appeal, the drug could be available as early as next year. of a ruling women like amanda parish are eagerly waiting for. >> i will be the first one waiting for my prescription. i believe that strongly in how it works and i believe that strongly that women deserve an equal opportunity to enjoy and become active members in their sex life. >> what would that mean to you to be first to market with this? >> it is much more than getting a drug approved. this is an important moment in women's health care. and in i think a societal moment around wom

and the fda's campaign, which mr. seller can't talk about, but we are excited about the work that they have been doing is also laser focused on youth and trying to keep experimenters from consolidating. we are doing very good things. the other thing to keep in mind is both campaigns combined represent in terms of the amount of promotional effort that we are able to make about five days out of the year compared to what the tobacco companies are spending. >> you're talking about both combined? >> both the fda and cdc campaigns. the 365 that would be funded by the tobacco companies? >> right. >> just elaborate on the real cost. >> sure. unfortunately, too many kids experiment with cigarettes. over 700 -- each day. over each day they make the progression to becoming real smokers. compared to 20 years ago, those numbers are done. the bad news is those numbers are still unconscionably high from a public health perspective. their 25 million 12- to 1 in theolds country, and what we came to understand is there's about 10 millio

there was a drug called ambien that the fda said, hey, this is affecting people the next day. they're taking 10 milligrams to sleep, next day, they can't drive, they're groggy, excess dreaming, waking up in the middle of the night from this. same issue with lunesta which is even longer acting. the fda is now wisely suggesting that instead of taking 3 milligrams a night, use 1 milligram, maybe 2 milligram. >> cut it in half? >> well, you can also get it in the 1 milligram dose. start with a lower dose, try not to take it every night. work on sleep hygiene first and get your doctor in the loop. and doctors out there, stop prescribing so much of this stuff. that's my message. >> that's a strong message. what do you think about taking lunesta or the sleep aids? are you for it? >> well, i think we have encouraged people to be able to sleep seven hours, at least, because if you really have insomnia and can't sleep well, the health hazard is tremendous and it can affect you. but i agree with marc that you should not take these medications, somewhere between 30 million to 50 million o

the fda is researching and going into the raw meats and finding over 80% of the ground turkey out there is infected with this resistant bacteria. over 80%. chopped meat, about 55%. this is an incredible epidemic problem among the beef. >> but we don't want to spoil the memorial day. >> cook the turkey. >> well done is the way to cook it. >> well done, but not burnt. >> right. >> memorial day weekend is the official kickoff for the summer and when the summer comes that means a lot of us will be under the sun, but skin cancer happens to be the leading cause and most common cancer here in our country. some critics say the u.s. is still way behind making available the best and most effective sunscreen products. the stuff you put on your face and elsewhere. dr. siegel has more about that. >> one of the best protections against skin cancer is daily use of broad spectrum sunscreen, but experts say the most effective kinds which prevent skin cancer and wrinkles are not available in the united states because of bureaucratic delays within the food and drug administration. >> there are effective c

i have had long conversations with the fda about it. the country is alarmed over it. zar and, the drugs c so on along with attorney generals and social workers and the like. movement orming fear in that group was this a new drug. that you would reconsider the decision and reconvene the advisory committee. these are the experts that nowkw drugs. i hope should reconvene to reconsider this drug now. especially since the company that makes it now says it will not take into long to perfect a pill that is abuse deterrent, that cannot be crushed. ould at least wait until that time comes. chairman rogers, thank you very much for being with us on "newsmakers." andrew, let me begin with you. they are working on this 12 spending bills to fund the federal government. it sounds like positive. sounding a lot of positive things. you do not really respond when push themna tried to into areas where he might have some roadblocks. i thought it was interesting that he said election will have a lot to do with this. they will not get everything done on this timetable. he wantedresting that

today the fda said sun lamps must carry the kind of black box warnings you've seen on cigarettes. these aimed at young americans and abc's rebecca jarvis has the story. >> reporter: for years doctors have urged the u.s. government to take action on tanning beds, but tonight for the first time, new rules. tanning beds must now carry a visible warning, cautioning anyone under 18 not to use them. >> we as dermatologists have been trying to deal with this issue for the last 20 years with the fda. >> reporter: the tanning industry calls the rules exce excessive and say their products, if used properly, are safe. 1 million americans tan every day, especially young people. in fact, by 12th grade, 32% of girls say they've used a tanning bed. using an indoor tanning salon increases the risk of melanoma, the deadliest of all skin cancers by 59%. katie is a survivor, she started tanning when she was in 6th grade. >> i thought there's no way as a 17-year-old i can have melanoma. >> reporter: a 2012 "20/20" investigate of tanning salons showed many salon worker denying their machines can be ha

why won't the fda approve it? do you buy their argument? >>> starry night, the spectacular show in the sky overnight. will there be an even better show tonight? >>> good evening and thanks for joining us on a saturday night. we do begin with that deadly rampage. tonight police calling it a premeditated mass murder. it lasted several minutes. shaken young people, witnessing it all in the street, stunned when it was finally over. authorities say this is the gunman's bmw where it crashed to a stop, the windshields shattered after shootouts with police. the bodies covered in sheets on the ground, six victims. tonight there is an intense focus on a hollywood director's son believed to have been driving that car. his videos posted on youtube, many of them could hold chilling clues. listen. >> i've been doing a lot of thinking about how sad and unfair my life has been all because girls haven't been attracted to me. >> we have team coverage tonight, what do the experts see in those tapes. were many warning signs missed? first we begin with bazi kana

there's a drug cam ambien that the fda last year said this is affecting people the next day.are tracking ten milligrams, next day they canned drive, are groggy and can't wake up from them, don't know what happened and same condition with lieutenanta which is even longer acting so the fda is wisely suggesting instead of taking three milligrams a night use one milligram, maybe two milligrams. >> cut it in half. >> you can also get it in the one milligram dose. start with the lower dose and try not to take it every night. work on sleep hygiene first and get your doctor in the loop and doctors out there stop prescribing so much of this stuff. that's my message. >> a strong message. dr. samadi, what do you think about taking lunesta or the sleep aids? are you for it, or do you agree with dr. siegel? >> i think we have encouraged people to be able to sleep seven hours at least because if you really have insomnia and you can't sleep well, the health hazard is tremendous and it can affect you, but i agree with marc, that you should not take these medications. somewhere between 30 mil

all of that is overseen by the fda, who i think has done in general a good job here. not perfect but a very good job. and we shouldn't disrupt that. we've gotten a lot of new drugs over the past few years precisely because we follow this orderly process. and also, we have a lot of therapies for aids precisely because we follow this same orderly process. >> so frank, let me get your thoughts on that. and also speak to what the fda says here, which they already allow access to these kind of investigative drugs. outside of clinical trials they have something as you know that they call the expanded access or compassionate use provision. and it basically allows for access to experimental drugs outside of a clinical trial. the patients must have a life-threatening disease or condition and no therapeutic alternatives. a manufacturer and the doctor then would make special arrangements. why isn't that enough if that's current federal law? >> well, we've got two questions there. so i'll try to go with the first one. and first of all, no one was listening to what i was saying whe

. >> the fda keeps drug companies on the honor system.hese drug companies violated the honor system. ultimately, destroyed documents. it kept them out of the legal system. stuart: this was testing on children. that is not allowed in america. >> the fda said you could not do it safely because of bladder cancer concerns. they said that they would just go to europe to do the test without telling the fda. they wanted to do the test on kids because they thought it would make them 2 billion more dollars. stuart: what happened to the children? >> at this point we do not have the documents and we do not know. there were basically nine different areas that i addressed with the jury. nine different areas of agree just comments that not only put at risk the people, but so unfair to the other good drug companies. they should be outraged. stuart: you do not think that the 9 billion will stand. you think that will be reduced? >> of course. the appellate courts will also reduce it. the jury was not out to see that 9 billion was collect it. they were out

the fda approved it even with opposition from many centers. and lawddiction experts enforcement around the country alarmed. there are ways to make it tamperproof and ways to make it you cannot turn it into a powder and stored it or inject it. you know the problems we face in every part of the country with prescription drugs. would you review this decision by the fda when you are in office? >> the issue of ,rescription drug abuse is one being from a world community in southern west virginia, where i have seen his issues firsthand in terms of how damaging they are to both the health and the economy. an issue i take very seriously. one of the things i want to do when i am confirmed is that i work with the da on science-based decisions. if i am confirmed, this is something i would want to understand how the decision was made. >> thank you. again, i hope you will be actively involved. i understand the necessary caution when sitting at the table. but i know who you are and i think you will get involved. medicare advantage. senator crepeau talked abou

and here's what the fda said. not used were supposed to be used as preventative medicine and those who don't have a history of heart attack or stroke. >> exactly. it is waiting the benefit and the rest. even though it's over-the-counter, even intracerebral, there's allergic reactions and you just have to be aware of that. in an older patient population, there are those that are at risk of following in hitting their heads. so needs to be weighed by the doctor. but what we do is focus and try to really determine the risk with various types of testing. gerri: this is all brought up because they're aspirin wanted to really market itself. do you agree with what the fda did? >> they did a very nice analysis relating to this and it clearly shows that there's no great benefit to that group of people. they did leave the door open saying that there's ongoing studies and let's see what happens over time. at the present time we cannot recommend as preventative way for people who have an increased risk of heart disease if they

merck shares have rallied this year into the fda decision... the fcc thinks twice about net neutrality.new language out of the chairman's office comes after a considerable outcry over a proposal put forth last month. the original language proposed changes that would essentially allow the internet to be divided into a fast lane for content companies willing to pay for it and a slow lane for the rest. the new draft includes language about the f-c-c scrutinizing deals to insure that non-paying companies will not be at a disadvantage. a quick check of the latest round of earnings points to postive signs for the economy. around 453 companies in the s&p have reported results. according to bloomberg news. 76% turned in profits that topped analyst estimates. based on corporate projections-- profits are expected to rise 7.2% this year. walmart's banks are under fire for fee collection. according to the wall street journal ,banks under walmart's umbrella of services are some of the biggest collectors of fees in the country. out of 67-hundred banks in the

just this past month the fda said it had received 4800 illnesses of pets being sick. es are under investigation. >> the fda received more than a thousand reports of dog deaths. >> cnn lina matello talks to one woman who nearly lost her pet to these toxic treats. >> reporter: meet sadie from florida whose brush with death still haunts her owner. >> she started throwing up blood. she started passing blood. she actually was throwing up blood clots that looked like pieces of liver. >> reporter: sadie's vet thought it was due to the treats. >> i was devastated. i almost started crying in his office. i thought, i killed my dog. i had no way of knowing that. you go to the store, you look at chicken treats. they looked like something i would eat myself. >> reporter: it turns out sadie is not alone. the food & drug administration has received more than 4800 complaints over sick pets, including 1,000 dog deaths possibly linked to chicken, duck, or sweet potato jerky treats. >> it doesn't surprise me. that number is probably a lot more. the fda is only able to go to the numbers r

thinks confirmed by the fda looking at our clinical trial. looking at the data submitted to them and part of the approval agreement. >>reporter: still complaints continue to come in to patient web sites including women who say they have been forced to undergo reversal surgery to remove the device. gabby says she is scheduled to upped go surgery this week and believes the device should be removed from the market until the safety concerns are better understood. >> i think the device has a reason hat a purpose and can be effective but if all those piece office that puzzle don't come together correctly, there can be some terrible terrible fall out from that. >>reporter: kristen z abc 7 news. >> in and out assure device also approved in canada and about to begin clinical trial in europe. american college of ob-gyn compared data on the effectiveness of this and other method of birth control but no current advice regarding the complaints collected on patient web sites. >> all right let's tour our attention to the weather forecast which may believe it

a wake-up call from the fda. experts worry that the starting dose of a popular sleep aid, lunesta is too big for many people. o the results can affect your life and abc's chief medical director is here to break it down for us. >> basically the fda is saying anyone starting on the drug lunesta or generic should start at half the dose recommended. instead of two milligrams, it's one. the reason for that is the effect of the drug lasts into the morning. take a look at the recent study. 7.5 hours after taking it, many people impaired. problems with memory, coordination. you wouldn't want to be driving. it continues past that at 11.5 hours. some people still impaired and didn't know it. >> at 11.5 hours. >> that far out. >> so the bottom line for everyone tonight? >> start with as low dose as possible. for many people that tiny dose is all they're going to need. >>> now we turn to the nationwide out cry on sexual assault on college campuses.ÑmmÑ so many allegations that tonight a kind of secret avenger is on the move

this week, the fda detained or seized hundreds of packages at u.s. mail facilities containing illegal prescription drugs. >>> while those mail order pharmacies may be the only way some can afford their prescription medications as the price of drugs seems to climb higher and higher. so why do brand name drugs cost so much and can anything be done about it? meg terrell gets some answers. >> reporter: when it was approved in 2001, the cancer drug and others that followed enabled patients to live almost normal life spans, the price about $30,000 a year, now it tripled to $92,000 a year. everybody is taking notice. >> access really is a problem for a lot of patients in relation to these very costly medicines. we sometimes think well, people have insurance and under obamacare there is a lot more coverage. but what that does not take into account is that very often there is a big co-payment that the customer has to come up with that is often many, many hundreds or thousands of dollars. >> reporter: some doctors think about price when prescribing medicines. z

the fda will be notified then the fda will notify the vendor and they start working on a fix. >> theof government turn so slowly, this is the kind of information that you want back to vendor very quickly. >> yes, exact. >> i. >> do you get the sense that it gets turned over rapidly. >> i think it does. the fixes do not get turned over very rapidly. so if we look at the historical, you know, context that we have for devices like this, it could take years for a software update to come out for a device like this. >> wow. >> so that's a big window. right? for any kind of devise, so hopefully things move faster in the future, but right now it is a slow process. >> well, unlikely allies are teaming up to protect you from potential internet bugs, up next we discuss the crucial market for hiring hackers. their employers might surprise you, plus we'll speak to a scientist and hacker who just hacked his own body to treat a chronic condition a few days ago, hear his bizarre story next. ♪ ♪ consider this. the news of the day plus so much more. answers to the questions no one else will ask. >> it

thinks confirmed by the fda looking at our clinical trial. looking at the data submitted to them and part of the approval agreement. >>reporter: still complaints continue to come in to patient web sites including women who say they have been forced to undergo reversal surgery to remove the device. gabby says she is scheduled to upped go surgery this week and believes the device should be removed from the market until the safety concerns are better understood. >> i think the device has a reason hat a purpose and can be effective but if all those piece office that puzzle don't come together correctly, there can be some terrible terrible fall out from that. >>reporter: kristen z abc 7 news. >> in and out assure device also approved in canada and about to begin clinical trial in europe. american college of ob-gyn compared data on the effectiveness of this and other method of birth control but no current advice regarding the complaints collected on patient web sites. >> all right let's tour our attention to the weather forecast which may believe it

it's regulated as a food by the fda. it's not a supplement. >> and did you have to -- what kind of regulation do you have to go through to make that claim that it's a complete nutrient system? >> so all the ingredients are generally recognized as safe by the fda. we're regulated similarly to a premade salad. because, all of the ingredients are approved in that manner and -- >> a really shocking report from someone who spent time in your factory and said it was, you know, pretty disgusting condition, to put it bluntly. what is your response to that? have you cleaned things up? >> sure. so, the reference there is tilely when we were doing our sort of beta product. where that was a facility in oakland that we don't produce in, never produced in en masse. that was something that was a very temporary space that we were using -- >> you were producing it for yourself. >> for ourselves and just close friends and family. our ingredients and our product is produced rfi food ingredients and they have an outstanding safety record for

despite the investigation, fda says it still can't figure out why the pets are getting sick. live in union city, terry, shoppers were clamoring for this change. >> clamoring for a change and tonight they got it in spades. not only is petco pulling the chinese doggy treats from the shelves by the end of the year but now we found out that pet smart will follow suit. this is two years too late for rachel chambers of morgan hill to save her dog, cally. >> good girl. can you sit? >> rachel chambers love hes her family's four dogs, just as she loved cally, a shepherd mix that died a painful death after eating chinese made dog jerky two years ago this month. >> important that more lives are saved. but incredibly sad the lives that are lost during the two years they should have done something. >> the fda hasn't identified the exact ingredient that has sickened and sometimes killed animals but petco decided now is the time to act. >> we decided at this point we want to good ahead and make this move even though the evidence is tlnt. because it is the best thing for our pests. >> i aske

thinks confirmed by the fda looking at our clinical trial. looking at the data submitted to them and part of the approval agreement. >>reporter: still complaints continue to come in to patient web sites including women who say they have been forced to undergo reversal surgery to remove the device. gabby says she is scheduled to upped go surgery this week and believes the device should be removed from the market until the safety concerns are better understood. >> i think the device has a reason hat a purpose and can be effective but if all those piece office that puzzle don't come together correctly, there can be some terrible terrible fall out from that. >>reporter: kristen z abc 7 news. >> in and out assure device also approved in canada and about to begin clinical trial in europe. american college of ob-gyn compared data on the effectiveness of this and other method of birth control but no current advice regarding the complaints collected on patient web sites. >> all right let's tour our attention to the weather forecast which may believe it

. >> meanwhile, have you heard about this study, the fda issuing strict new guidelines with aspirin, the agency saying that aspirin shouldn't always be seen as something that can help prevent a first heart attack or stroke in people who don't have any casorio vascular history. dr. siegel, this is huge. everybody says take a baby aspirin, take a baby aspirin. it can help. it's the magic drug and now the fda says what? >> first of all, i want to start off by agreeing with the fda for a strange reason. i don't think anybody should go to their pharmacy and pick up an aspirin, which is a very active chemical, and decide they'll treat themselves with it. i think they have to go to their doctors and doctors will hopefully be following the guidelines of the american heart association who says people at very high risk should be on aspirin. it's been shown by studies, eric, that 17% decrease in women for stroke over the ages of 55 on aspirin, over 30% decrease of heart attack in men over the age of 45 in aspirin, but we have to see it in conjunction with what are your risks of bleeding and risk

the fda has approved a new drug with a risk of people who have heart disease. stopping the formation of blood clots, but the side effects, well, it includes an increased risk of bleeding. the drug's approval comes the same week as the fda announced taking aspirin on a regular basis raises your risk of stomach and brain bleeds. let's weigh in on these risks with dr. david somati, professor of urology at the hostra long island school of met sin and member of fox news medical a-team. this new study, what should be my concern. >> i just want to mention what you just said about aspirin, which is fda and aspirin. and for years, we talked about how aspirin can prevent heart attack and stroke. so everyone went out there and they started taking baby aspirin. and that led to a lot of stomach bleeding, stomach ulcer, you see blood in the urine, blood in the stool. and now fda wants you to know that if you have had a heart attack in the past, talk to your doctor and then you may be able to go on aspirin. but don't go out there and randomly start taking these aspirins on you

the fda did the same thing with ambien last year. >>> when we come back, a stirring tribute. command performance at the 9/11 memorial museum and for her how it was so deeply personal. >>> finally tonight, a moment of amazing grace today dedication ceremony by a woman who was called in at the last minute to perform after another broadway star got sick. even for a tony award-winning actress, this was no easy task. quite the contrary, because she has her own connection to 9/11 and the sacred ground beneath that ceremony today. ♪ amazing grace >> my name is lesean and i'm the widow of calvin joseph gooding who was lost in 9/11. we have two beautiful daughters. calvin lived life. he's a beautiful spirit. i loved him from the moment i saw him. my oldest daughter, who is the most sensitive to the loss of her father being in the museum today was a bit overwhelming for her. my other daughter, the one who wasn't even born yet, she's much more curious. i ask zyia my youngest to find her father. when she sees him, there he is, mom, i want to take a picture of my dad. this is a girl tryin

the food and drug administration does not regulate the term, all natural. fda has not develop ad term for the use natural and derivatives. they don't object if the food doesn't contain added color or artificial flavors or synthetic substances. what should the fda do? what should consumers do? even if the fda changed its mind nothing would change quickly? >> this has been an issue for a long time. for decade the fda is afraid to take on food processors and take action on this. they should start to look at this word. there has been so many lawsuits that a few months ago some of the judges in a different lawsuit urged fda to look at this because there is such confusion and really being worked out in the courts. fda said, oh, we don't know if we're going to touch it. we need fda not allow the use of word, that is one option, use natural on processed foods or set terms that people can rely, i know it means this, this and this. you may not agree with the terms but at least you know what they are but now it is chaos. gerri: it is chaos and it will not change anytime s

we're close to filing that documentation with the fda. getting it to them. they'll have about six months to review it and hopefully get the drug approved and launch the product as early as first quarter of next year. that's where our focus is. we're very excited to finally after ten years to be able to bring perhaps the first drug ever for this uniformly fatal lung disease and we're focused on that. >> as i studied i was not able to find necessarily other drugs that i thought would be in the pipe. but it does seem this particular drug might have more uses than just the one you're talking about. >> that's right. it could be a portfolio within product for example. there's another disease called scleroderma which is a terrible disease. it's about as large as ipf and like ipf there's no drug approved and it's caused by fibrosis. so it is a drug that slows the process of scarring. so scleroderma is caused by scarring and it could work there. we have an on going phase 2 study we're excited back and further back in our research we have a number of antiscarring medic

regulation at all but in april, the fda proposes to change that. was long overdue with a potential $3 billion business needed. dr. hamburg says the agency is working for more feedback before making a decision. we imposed a rule that would enable us to broaden our authority to regulate the full range of tobacco products including e-cigarettes. as is out for comment right now and a lot of interested stakeholders will move to the final ruling, and that will give us the foundation to regulate these other products that are in the marketplace, and be able to really assess what needs to be promote health and protect safety. >> i know you are still getting comments but what will change for this industry once the final ruling is adopted? what happens overnight, because there is no regulation right now? >> a couple of things will happen with the completion of the final rule. there will likely be other steps taken over time, but most importantly they will no longer be able to sell the e-cigarettes to youth under age 18. they will have to report to us about the

the fda approved it even with opposition from many centers. nd lawddiction experts enforcement around the country alarmed. there are ways to make it tamperproof and ways to make it you cannot turn it into a powder and stored it or inject it. you know the problems we face in every part of the country with prescription drugs. would you review this decision by the fda when you are in office? >> the issue of ,rescription drug abuse is one being from a world community in southern west virginia, where i have seen his issues firsthand in terms of how damaging they are to both the health and the economy. an issue i take very seriously. one of the things i want to do when i am confirmed is that i work with the da on science-based decisions. if i am confirmed, this is something i would want to understand how the decision was made. >> thank you. again, i hope you will be actively involved. i understand the necessary caution when sitting at the table. but i know who you are and i think you will get involved. medicare advantage. senator crepeau talked about

the fda says the daily dose of aspirin should only be used by people at a high risk of heart attack and stroke and only under a doctor's care. >>> "early today" is brought to you by vagisil, the experts in intimate health. >>> time now to get down to business with cnbc's courtney reagan. good morning, courtney. >> good morning, betty. stocks rebounded from a big drop at the open monday, following a better than expected report on the nation's services sector. the dow avoiding a three-day losing streak. look for data today on the trade deficit. for the first time in a decade, data shows walmart's internet sales are growing faster than amazon's. amazon's total sales are still six times bigger than its ten competitors combined. walmart is spending heavily to boost its presence onlynineonli >>> google is taking on amazon. google charges $4.99 per order, while amazon charges $9.98 for same day delivery in 12 u.s. cities. for now, google is offering free membership for six months. betty? >> thank you, courtney. >>> newly released data shows proof that airlines are making big bucks off your bag

the fda, of course, is in charge of making that food and drugs sold in the united states are safe. and if the fda comes and inspects your manufacturing plant and they find you are out of line with current good manufacturing practices, they issue something called a 483. if you're running a drug manufacturing facility, you do not want the fda to give you a 483. they can shut you down. and in 2010, this factory in rocky mount, north carolina, it got two of these 483s. they got the warning letter in april, the first 483 violation in june, the second 483 violation in august. that plant in rocky mount, north carolina, was in big trouble. and so the company running that plant decided to try to save its business, in part, by moving its manufacturing of some of its drugs to other facilities in the company. specifically, they decided to move the manufacturing of one of their drugs called sodium pyathental to a factory they operated in italy. and here's the problem, it's an anesthetic used for knocking people out so they can have surgery or whatever. but for years, that anesthetic had also be

the fda said after looking at the data, over a long time, they're not prepared to say that.pirin, which is 81 milligrams, can potentially prevent someone who's already had a heart attack or a stroke, from having another one, but not as good necessarily at preventing the first one. so that's sort of the genesis of this whole thing is this labeling issue. but it's re-stirred up this whole question. >> there's one argument that people say, well, take aspirin. they might not help, but can't hurt. but the counterargument, for some people it could hurt, right? >> everything in medicine is a risk/benef risk/benefit analysis. sometimes it can be confusing even in the medical community. how much value to you give to the benefit and how much to the risk. the concern is, when you take aspirin, you're thinning your blood a little bit. you're more likely to bleed. if you have ulcers in your stomach, they may be more likely to bleed. that's a potential risk. compared with the small benefit, at least the people who have never had a heart attack or never had a stroke, the small benefit of p

. >>> the fda approves a new robotic arm. >>> plus was it an act of god that stopped this boulder from cru crushing this church. sdplnchts and born holding hands. the incredible story behind these twin girls. that is next. i make a lot of purchases for my business. and i get a lot in return with ink plus from chase like 60,000 bonus points when i spent $5,000 in the first 3 months after i opened my account. and i earn 5 times the rewards on internet, phone services and at office supply stores. with ink plus i can choose how to redeem my points. travel, gift cards even cash back. and my rewards points won't expire. so you can make owning business even more rewarding. ink from chase. so you can. >>> let's get down to business. >> the futures higher this morning as the markets are coming off a mixed week. the dow notching its second record close of the year, but the nasdaq suffering its worst week in a month. look for reports on housing this week. >>> expect a little more cash in your paycheck. a survey finds a majority of economists think wages will climb and that will fuel a more rapid

the fda is saying not so fast. you will speak to the doctor about the concerns. >> violence growing more deadly in ukraine. the white house has a new tool to use against russia and new questions about the administration's response to the benghazi attacks as we hear from the man who will head the select committee looking for answers. >> we need a list of the documents and by the way, i am not interested in redaktive documents or classification. i want all of the evidence and people can draw different conclusions from the facts and evidence. and you can't draw conclusions if you don't have all of the facts. cúp,@s#b people join angie's list for all kinds of reasons. i go to angie's list cúp,@s#b to gauge whether or not the projects will be done in a timely fashion and within budget. angie's list members can tell you which provider is the best in town. you'll find reviews on everything from home repair to healthcare. now that we're expecting, i like the fact i can go onto angie's list and look for pediatricians. the se

these times of issues and the fda was present. it was really a partner in trying to make sure the industry moves forward. >> did you a secondary and then it went very well. and then you brought 3.3 million shares. it is a very fine outfit. and people were surprised. why was not that part of the secondary? and some something we should worry about? >> we went through the process where we are private equity owned. we're still a controlled company at this point. and essentially, the secondary was very successful for our investors overall. we had a little extra cash in the books and we think it is very important to use our cash effectively. we could create a very effective transaction. tpg had a funneled open in 2003. intended for a ten-year life so they didn't have pressure on those shares. we're able to take care of that and create a win for the investors. >> that makes a ton of sense. it is good because -- we have a enough cash to do it. most companies do not. >> recommended right out of the chute because it's got a great business mo

. >>> the fda approved a new robotic arm, plus, was it an act of god that stopped this rolling boulder from crushing this church? and born holding hands, the incredible story behind these twins when "early today" returns in two minutes. >>> it has been almost three years since the washington monument had to close because of daniel from a rare earthquake. today, it will finally reopen. the monument's whitemar marble mortar were cracked due to a quake in 2011. and now that damage has been repaired. let's bring if tracie potts in washington. good morning, tracie. what is taking the repairs so long? >> reporter: well, it took them over two and a half years because as you said, there was so much damage, there were pieces that fell on the inside, the elevator was damaged, pieces that fell on the outside, there were cracks, betty that were so big, you could see light coming through them. so they wanted to make sure, number one, that it was repaired and also that it was earthquake proof for the future. so there are dozens and dozens of steel plates holding together the marble and the granite,