when the fda came to testify, he said the fda was confidant fends into the marketplace were safe. i asked representative kate web, majority leader if she agreed and she did. i assume you do? >> i do. >> thank you. i yield back the balance of my time. >> we will have questions in writing we will submit to you. we ask that you please respond. i remind members they have ten business days to submit the questions for the record. that means they should submit the questions by the close of business on thursday july 2nd. very good hearing. very important hearing. thank you for your testimony and your expertise without objection the subcommittee hearing is a o adjourned. >> the house and senate are out of session until september, tuesday 8th, both are expected to take up the nuclear deal with iran and they will note on nominees on the first day back. when the senate returns, live coverage here on c-span2. >>> congress is in recess for it summer district work period. and all month we are bringing you booktv in prime time. tonight after words interviews on books about the white house. chuck

what are the implications for fda? how does fda need to evolve given the advancements in science?r. soon-shiong: i think the issue, and you brought up precision medicine, this is a bipartisan event. it is so fantastic as far as timing. what i will do is lay out -- i spent 30 years of my life now looking at this issue of cancer. then, leaving the university to develop a jug for breast-cancer the granite cancer, e -- over aarian cancer, and lung cancer. the reason we are losing is because we have gone down the wrong assumption. i will explain how precision medicine can save us. we have always assumed, as a nation and a society, that cancer was a single clone. this horrible clone that happens in your cell and in this clone grows, and you would kill it. for 40 years, we have a going down this pastth of single jug therapy or radiation therapy. it makes sense -- cause i made sens -- quasi made sense of killing the cell and hope you come out of the allies with the clone dead, and your body alive. if that were true, we would have cured cancer today. that assumption is made by a single mat

the fda doesn't regulate the practice of medicine. nothing prohibits physicians from prescribing drugs off-label that you know will help them. manufactures interestingly are generally restricted, they can share that information, good, accurate information off-label use of the product. that inability to share is a huge barrier into effective and safe use of those drugs. in order to balance the risk and benefits of off-label uses, physicians, that doctors have to have that information, that i could information that right now is being denied them. nobody is intended to deny. as an example of an example of an antiquated structure very good for the times, right now for the today, scientist and so fast, needs to be reform. we also call for harmonization of international requirements and standards. i think bart, you come to that because anyone of our discussions we know america is great, the best, the most innovative but they're good things happening around the world in a scientific way they need to be assimilated into our thought processes

when fda consultation is completed fda responds to the c. developer and a letter that fda has quote no further question about the determination that the ge crop is substantially equivalent to its counterpart. cspi believes fda should determine the safety of all ge food crops before foods from those crops enter our food supply. fda should review the safety data submitted by the developer conduct its own analysis of that data and provide the developer with this opinion and whether foods from ge crops are safe to eat by humans and all sprayed over the consistent with how most countries ensure the safety of ge crops are at h.r. 1 599 goes only a small step towards what we believe is the proper role of fda to ensure the safety of ge crops and the foods made from them. h.r. 1 599 would codify the current fda voluntary consultation process. does not require however fda to provide its opinion on each particular ge crop safety. in addition it does not put the burden of roof on the notifier to satisfy the fda that the ge food crops or ingredients made

how does fda need to evolve given all the advancements in science? >> so, i think the issue you brought up with precision medicine and have this is a buyer-- bipartisan event is so fantastic in terms of timing. what i would like to do is maybe layout-- i spent 30 years of my life now looking at this issue of cancer and as a problem. then leaving the university fashionable. [inaudible] >> through that event of a layup the problem. the reason we have lost the war and cancer is because we've got another wrong assumption and i will explain later. and i will explain how precision medicine actually can save us and then explain the urgency of what we need to do. we have always assumed as a nation and as a society that cancer was a single clone, so this horrible clone that happens in yourselves in a single: gross and utilitarian so, for 40 years we have been going down this path of single drug of chemotherapy, radiation therapy and it made sense if in fact it was a single clone that we are trying to kill this clone while we kill your normal cells. put you th

>> so, fda reviews all electronic transmissions. we utilized things like foreign inspection, domestic inspection, whether it was sampled in another port, all that information is gathered within the predict application and then that shipment will be given a risk score, the higher the risk score the more chances one of these officers will sample that shipment. >> once the fda inspector picks samples for inspection they are sent to a fda lab like this one in irvine california. >> are you making a shrimp smoothie? >> i'm making a shrimp powder. >> its like a magic trick! >> yes. >> the shrimp powder is mixed with a chemical solvent, dried and liquefied again to run through an analyzer. kai wang is a fda chemist. >> so kai the results are in from the test, what are they showing us? >> in this case, the compound i am looking for is nitrofurons. >> and how dangerous is that for human beings? >> nitrofurons are dangerous for human beings because it's carcinogenic. the fda action level for nitrofuron is one parts per billion. one parts per b

but some critics, including doctors question the fda's approval.es show the drug can cause a sudden drop in blood pleasure. that can lead women to faint and can leave them groggy the next day. the big question is also about the long-term effects of taking the drug. it takes at least eight week knows that it's working. >> what about cost? >> the pharmaceutical company has not set the price point, but they say they want it to be comparable to viagra. >> randall pinkston thanks for laying out the issues there. this doctor was an obgyn at the university of chicago medicine. she joins us via skype to talk more about this. thank you for your time. let's start with the side effects, why has such a big deal been made about the side effects of this drug, because they don't seem worse than the ones rehear about for males. >> why we're putting particular emphasis on the side effects here i think is something of a rhetorical question, but they are very important and consumers need to know about them. >> how would you weigh the benefits and risks of this partic

but they were never evaluated by the fda for use in ear drops. over the years those medicines have been used a lot. and the fda is simply pulling the medical community back in to say wait a minute. there can be serious complications of these medicines. >> reporter: the fda is clamping down on companies that make and sell 16 different prescription drops for ear pain and swelling but weren't approved by the fda. this pharmacist is pulling these ear drops and the fda say manufacturers have to stop making them. >> now i can't even say that it's not going to harm you. >> reporter: the fda says patients should return drops with ingredients on the warning list and ask for a substitute drug. guidelines recommend treating ear pain with over-the-counter pain medicine and not using antibiotics unless your child has a high fever or there's a fluid build-up and discharge in the middle ear. dr. max gomez, cbs 2 news. >> medicine labels don't list whether or not they are fda- approved. we did put a link to the fda's website so you can search for specific medica

it was rejected who times by the fda -- two times by the fda. name of the ebix a group is advocacy group-- is even the score. a group supporting the approval of a drug -- betty: even the score. at least they did so yesterday, one step further. on that note, i say goodbye to you. much more ahead in the next half hour. investors have dinged up on the liquidity question -- dinged up on corners of the market over the liquidity question. ♪ this is a great place to work. not because they have yoga meetings and a juice bar. because they're getting comcast business internet. comcast business offers convenient installation appointments that work around your schedule. and it takes- done. - about an hour. get reliable internet that's up to five times faster than dsl from the phone company. call 800-501-6000 to switch today. perks are nice. but the best thing you can give your business is comcast business. comcast business. built for business. great time for a shiny floor wax, no? not if you just put the finishing touches on your latest masterpiece. timing'

this is why we have an fda to test drugs, to make sure they are safe and effective. that is the process medical marijuana needs to go through. i was told last night by one of our law enforcement officials that the fda has approved a synthetic pill which is a derivative of marijuana. so it does appear there are some things we have alternatives rather than the states creating this patchwork of laws and the proper way is going through the fda to create whatever derivative of marijuana we want to address specific issues and make sure they are safe and effective. >> campaign 2016 is right around the corner. if the road to the white house come to nebraska, what will they hear? governor ricketts: one thing you will hear is that people are concerned about the future. they want to make sure their kids can continue to grow up in a place where they have the opportunity to pursue the american dream and they are concerned about the direction the country is going and the influence of washington, d.c. most nebraskans are engaged locally and would prefer the federal government stick

the fact that the fda approved it is a moot point.the physicians to prescribe it properly. >> doctor, what do you think of that and the risk that physicians now, it was allowed, you were able to prescribe the pain killer before. the fda stamp of approval puts it back in the news to talk about. what about the risk of overprescribed for children and sets them on a path for addiction? >> you know, there is a real chance for addiction, and i completely agree the opiate addiction is horrific and growing and we regularingly do see this trend from perqoset to heroin and we understand, and i see and deal with regularly in our emergency room. we are aware of this. we know that we are only going to prescribe these drugs to patients who really need them and in a highly regulated manner. the fda approval will is already for patients tolerating a baseline narcotics and oxycontin is a slow release of oxycodone being approved. actually, the fda approval comes with specific recommendations and limitations which just puts more reminders on the physici

if the fda is using that authority? >> there are a number of pathways the fda has to provide patients with access to important new drugs treating serious or life-threatening conditions. there are at least five different pathways that have the intent of trying to speed new cures to market. last year, approximately two thirds of all of the drugs approved by the fda were approved by a one of these accelerated pathways. not only do they have these pathways in place but they are using them liberally. if you look at the statistics, a lot of new drugs are being approved on the basis of studies in treating aisle markers -- biomarkers. most new drugs are approved on the basis of studies in six months or less despite the fact they are intended for chronic disease and used for a lifetime. the actual statistics and data on support the industry's assertion that there is a long and arduous process for testing and approving new drugs once it is known those drugs work. it is quite the opposite. >> that is very helpful. lowering fda sta

they are keeping up with the kardashians even at the fda it seems.e this out of the goodness of her heart and said there's this drug out there i really like and she's not being paid for it, she wouldn't have been in any trouble. because the company is paying her to be a spokesperson and she's not telling the whole story in her instagram post and facebook post and the twitter feed, that's when the company gets in trouble. >> so what are the concerns associated with this drug? there are a lot of women who suffer from morning sickness and they are looking for something healthy that will help them. >> it's the things that you see often with any kind of drug advertisement on tv. there are side effects if you're allergic to some of the ingredien ingredients, there's drowsiness, things like that. it doesn't appear it's any different than any other drug. when you see a commercial, they list all the good things about it and then they always have that long warning about all the side effects. drugs that you shouldn't interact it with and things like that. in th

it was twice rejected by the fda for being too unsafe.h new modifications it has been a approved after an aggressive marketing and social media campaign back to by the manufacturer, sprout manufacturers. they are celebrating. >> where glad to have the first approved drug for this condition. it has been a quiet but it process with the fda to come with appropriate language in the label. >> the husband and wife team who bought the rights to the drug effectively turned it into a issue of sexism, accusing the fda of being more interested in men's sexual problems than women. >> it pressure group emerged called even the square with the goal of leveling the playing field when it comes to the treatment of women's sexual dysfunction. the organization was wanted in part i sprout pharmaceuticals. they produced parity ads like this. >> it is just you and your lady. the setting is magical. then, erectile dysfunction comes, but then lucky for you you have countless medication options that will make you as randy as a teenager. too bad your lady does not

. >> i got my results sent to me before the fda ban. >> my health risks just loaded.irst one would give any woman reason to pause. the number one thing that i have the most elevated risk for is breast cancer. when the fda ordered 23andme to stop offering medical advice, they also pulled the plug on some of my results. i'm here with dr. human alie, the one that alarmed me the most is how breast cancer is elevated more than anything else. what do you mean by genetic variants? >> a change in the single position of the dna variants. at 24.4%, when the norm is 13.5. but professor alie says risk isn't just based on genetics. >> overall history is more important than the eight variants. because we know it's not just the eight genes that are associated with breast cancer. 50 perhaps 100. >> no one on my family or the other side has been diagnosed with breast cancer. >> right, then i would be unworried about the 23% above the general risk or average risk. >> it is up to debate how much this 23andme genome test is going to change gene sequencing. aa little optimistic. the final

. >>> we are watching for a big decision from the fda tonight. this involves the female libido pill. there are some conflicting thoughts on the first of its kind of medication. >> it has been dubbed the viagra for women. millions say they are effected. the fda could either say yes, no, or we need to postpone our decision. their love story began in front of a crowd. chris campbell proposed to katherine while she was singing with her band. >> he's absolutely wonderful. she's perfect for me. >> reporter: married three years, chris and katherine now have two young boys. >> one day, i had this great awesome sex drive and this great relationship with my husband and the next day i didn't any about it anymore. >> reporter: now the fda is considering the approval of a drug meant to help people like katherine. >> i just say, i'm so sorry. there's nothing that i can do. >> reporter: the drug is what some call female viagra. viagra effects the ability to have sex. this drug works to increase desire by changing chemical levels in the brain in women whose libi

the fda approved the drug. carolyn tyler has the pros and the cons. >> the nurses at stanford's dye dye -- gynecology clinic fielding calls wanting to know about the so-called female viagra. it is pre-menopausal women with lola be dough. they say one in 10 women suffers from hypoactive sexual desire disorder. a stanford doctor conducted research in 2009 that found the brains of women with the disorder are different. she believes the new drug the fda just approved effectively targets the chemical imbalance. >> the data speaks for itself. people doubled the amount of sexually satisfying events who were on the drug in the study. >> the fda advisory panel heard from women who want the pill and received a letter of opposition signed by several health care advocacy groups including san francisco's breast cancer action . >> they are trying to sell hope and height. >> it does not show the benefit outweighs the potential harm of the little pink pill. >> this is a drug you take every day that stays in your blood stream a

this june an fda advisory panel voted 18-6 in favor of the drug. the panel hearing testimony from this mother and daughter. >> i had a wonderful loving husband and no sexual feelings whatsoever. >> my marriage has suffered greatly. so much so that the conversation of divorce is on the table, stemming from my low sexual desire. >> if approved the one a day pill would be the first of its kind available to consumers but it has already faced backlash. some questioning its effectiveness and safety, but for some women, this impending fda announcement could make all the difference. >> no negative side effects. only positive ones. >> really good ones. >> reporter: rebecca jarvis, abc news, new york. >> apparently this company marketing this started by a husband and wife team and they created sprout pharmaceuticals. >> no word yet on what happens if you experience side effects more than four hours. we'll see. coming up though, meryl streep gets a less on in how to keep on rocking in the free world. >> and two former colleagues battle it out over their new k

excitement about a new weight loss procedure just approved by the fda.octors at the mayo clinic say it could be a powerful tool in the fight against obesity. and the key feature is this silicon balloon. filled with saline. technique has been used in europe and australia for several years. it's now available here in the u.s. >> mark harrell land's dr. suggested he try something new to help him lose weight. >> they said do you want to be the first? i had to think about it and i said, let's rock. >> mark is 5-foot nine and weighs 221 pounds. he says even though he tries to stick to a healthy diet and loves to exercise, he is struggled with his weight for years. >> it's pretty obvious if you look at me i need to, you know, lose few pounds. i've been trying and i've been trying and i've been trying. it doesn't work. >> but maybe this will. >> this is a balloon. it's spherical looking balloon filled with salt solution stalled saline. >> the doctor oversaw the clinical trials of the oh bear row intra gastric balloon at the mayo clinic. >> decrease the amount of

fda says this approval comes with a boxed warning. the warning will alps apply to patients on certain medications and those with live disease. dr. jon lapook, cbs news, new york. >>> and coming up on "cbs this morning," cindy whitehead is in studio 57. she's the ceo of sprout pharmaceuticals, the company that makes addyi. >>> and motel 6 was evacuated moments before guests smelled gas. >>> and on the "cbs moneywatch," gm's possible chinese import and a recall. hena daniels is at the new york stock exchange with that and more. good morning, hena. >> good morning, alison. general motors may have a new buick made in china that that would make it the first detroit automaker to make a chinese vehicle in the u.s. it could be sold by the late 2016. the auto union workers is blasting the gm plan. >>> stocks in china plunged for a second straight day on fears of a further devaluation of currency. the shanghai composite lost 2%. hong kong's hang seng lost 1%. >>> here on wall street investors will watch for minutes from the federal reserve july

the fda warning hospitals, be on alert for hackers. here's abc's aditi roy. >> reporter: hospitals across the country receiving an unprecedented warning by the fda tonight, that a commonly used medical device may be at risk of getting hacked. the device, has pir are's symbiq infusion pump, is used to deliver medication ss like painkillers and cancer treatments to patients through an iv. in its warning, the fda says, an unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers. >> so, every hospital should assume that its devices, if connected to the internet, can be attacked. and so this -- it's an important warning. this is not an isolated incident. >> reporter: hospira says it deployed an update to provide customers with an extra layer of security, until the pump is completely off the market in a few months. a move already in the works before this warning. this new worry over health care hacks comes just after fiat-chrysler issued a voluntary recall of 1.7 million vehicles to install sof

shuren, how the tests that fda -- about -- the tests the fda is going to be assessing. one thing that concerns me that some tests may get quite expensive. i want to make sure that i understand how they and the highly personalized care that precision medicine can provide will benefit everyone. and won't contribute to health disparities in our country. so my questions are, will these tests be considered dyiiagnosti or preventive tests and who's going to be paying for them? >> well, in the case of next generation sequencing, they can be used potentially for both diagnosis and for predicting, in for prevention purposes. it all depends do you have the data to show that particular test can perform in such a way. in terms of reducing costs, there's the opportunity to reduce costs for those technologies to be developed. we have the standards i talked about and databases of information. it will be a lot less expensive to have the sign. in the past you do a clinical study, does your test actually predict or diagnose that disease? when database you might be able to point to the da

the fda approved the drug. carolyn tyler has the pros and the cons. >> the nurses at stanford's dye dye -- gynecology clinic fielding calls wanting to know about the so-called female viagra. it is pre-menopausal women with lola be dough. they say one in 10 women suffers from hypoactive sexual desire disorder. a stanford doctor conducted research in 2009 that found the brains of women with the disorder are different. she believes the new drug the fda just approved effectively targets the chemical imbalance. >> the data speaks for itself. people doubled the amount of sexually satisfying events who were on the drug in the study. >> the fda advisory panel heard from women who want the pill and received a letter of opposition signed by several health care advocacy groups including san francisco's breast cancer action . >> they are trying to sell hope and height. >> it does not show the benefit outweighs the potential harm of the little pink pill. >> this is a drug you take every day that stays in your blood stream a

. >>> the fda has you proved the first drug to boost women's sex drives. it's known as the little pink pill. it comes with a dose of controversy. >> did you hear the fda approved the first ever women's pill to boost sexual desire? >> some are banking the fda for approving the controversial drugs. low libido. sherry mike is one of them. >> it's caused a lot of husband, a lot of disappointment. >> the pill's approval didn't come easily. the fda rejected it twice, once in 2010 and again in 2013 for safety concerns. most common side effects include dizziness, nausea and fatigue. the manufacturer warns that when combined with alcohol it can cause fainting. >> dr. berman said the drug's risks are greater than the benefits. >> it's barely effective at all. it increases the number of sexually satisfying events by less than one event a month. >> this little pink pill is re -- referred to as the blue pill. comparisons company addiy and viagra are inaccurate. >> viagra increases blood flow. la bee toe is tough ibido is -- libido is tougher to treat. in october. today

> gentlemen, our first topic here is as the drug dubbed female viagra gets the green light from the fda is likening that pill to its male court parent. is that misleading? let's start with dr. samadi, is it misleading to say that this is similar to viagra? >> yes. would i certainly not use the term female viagra, because as a urologist we prescribe a lot of viagra, stylies and levitra. for men we're talking about the mechanical problem and below the belt. basically viagra brings blood flow and they can have great sexual activity and it works very well. take this medication as needed, when we prescribe viagra. this is a totally different medication and that's why i would not call it female viagra. sex among women is very complex. it's also mental and what's up there, the self-image of women and how they feel about themselves and the partner and this particular medication i would add was approved after two rejection periods by the fda works on the brain, serotonin and dopamine and originally prescribed as anti-depressant. the question is does it make them feel better and that's why there'

it had not been approved by the fda.ork with an advocacy group that helped to make this possible. >> science made this possible. an expert panel was assembled by the fda back in june. they voted 18-6 in favor of approval. that group was looking at a whole lot of scientific evidence. every step along the way, we have done extra clinical work. , we are oneadvocacy of 26 members of the coalition change thegned to conversation to patients became the center of this conversation. much of that credit goes to the fda. pimm: what is different about this formulation that was not approved before? >> not different in terms of formulation but different in terms of scientific understanding by more data. more data in terms of challenge studies, another pivotal trial, more evidence that made us comfortable that we had a level this label to inform patients. pimm: how much does something like this cost and how do you take it and will it be reimbursed by insurance? bedtime,once daily at nonhormonal pill. we've looked at prices not yet set,

. >> the fda says this approval comes with a boxed warning. the warning will alps apply to patients on certain medications and those with live disease. dr. jon lapook, cbs news, new york. >>> and coming up on "cbs this morning," cindy whitehead is in studio 57. she's the ceo of sprout pharmaceuticals, the company that makes addyi. >>> an explosion severely damaged a motel in bremerton, washington, west of seattle. the motel 6 was evacuated moments after guests reported smelling gas. firefighters were blown back 20 feet by the explosion. gas company worker was critically hurt with second and third-degree burns. >>> and on the "cbs moneywatch," gm's possible chinese import and a recall of an ikea nightlight. hena daniels is at the new york stock exchange with that and more. good morning, hena. >> good morning, alison. general motors may have a new buick made in china that that would make it the first detroit automaker to make a chinese vehicle in the u.s. a compact crossover vehicle could be sold by late 2016. the auto union workers is blasting

. >>> fda gave approval to a drug it's rejected twice before, known as female viagra. many say it will be a game changer for women. carolyn tyler is in the newsroom with more. >> reporter: well, men have the little blue pill, now, women will have the little pink pill as the fda approved a prescription drug for women with low libidos. dr. millhauser says it's an historic moem for women. she estimates one in ten suffers from the disorder. her patients are calling and asking for the so called female viagra. >> this is a condition where women, no matter what they try, cannot find that desire. >> reporter: millhauser conducted landmark research that found the brains of women with the disorder are different. she believes the new fda approved drug known as addi effectively targets the chemical imbalance. >> the data speaks for itself. people doubled the amount of sexually satisfying events. >> reporter: the fda advisory panel heard women who want the pill and receive aid letter of opposition, signed by several health care advocacy groups, including san francisco's breast canc

>>reporter: they said in part " will take quick action in response to the fda's letter in the post hadsince been removed from our page right or wrong she did what she was contacted to do which was to promote a product is on the marketing team at the drug company to know the fda rules. >>pam m: apparently it pays to be a female tennis star to renew williams' interline was a packet of the top three highest-paid female athletes to renew williams' was close behind with almost two to $5 million in fact there are seven female tennis players in the top-10. ? grant l: the pictures quarterback in nfl commissioner roger dale showed up today for settlement talks before a federal judge in new york brady was greeted by fantasy where inflated footballs on their heads the judge ended the public hearing early so books i could meet privately and try to reach a resolution he was suspended for four games for allegedly been generally aware that his team used under and play football during the playoff game in january and fell upheld the suspension last month in the nfl players union appealed on his behalf

the fda needs to have the fair balanced information where they disclose the warnings and the risk ofhe drug. cluded.tatements were not >> a drug manufacturer says in part, we will take quick action in responding to the fda's letter. in not before garnering 454,000 likes. >> this is a slippery slope. it definitely has promising marketers. with social media only allowing us to have much space to disclose information, drug makers are avoiding social media pause they don't have enough space to include the promot so plus the risk and warnings. >> let's get to donald trump's good and bad week. >> donald never has a bad week.n hollywood weighing in big time with fox news rival megan kelly. >> do you think megan kelly will get the last word here? let's go inside the nationwide topic dealing with the donald. >> i just got back from a weekend at the beach. >> you could see there was blood coming out of her eyes. blood coming out of where ever. >> trump will note apologize. and i certainly will not apologize for doing good journalism. >> she says many interpreted as being a sexist comment, whic

the fda,pproval by when female viagra could be hitting store shelves. and sensitive private information posted online. leon: former subway pitch man jared fogle is expected to plead guilty to child pornography charges. ago, authorities seized computers and other items from his home. the sandwich chain cut its ties with him. earlier this week, they arrest the head of his anti-obesity foundation member for child born charges. fda,e decision from the the agency has approved a bill known as female viagra. first --e bill is the thelittle pink bill is first for females. with insurance it could cost $70 per bottle, which is about the same as viagra. target will have to pay up for the massive data breach. they have reached a deal with visa to settle claims from the 2013 attack. it is reportedly worth a total of $67 million. neither company would comment on the specific amount. hackers made good on what could be a very embarrassing threat, information stolen from cheating website ashley madison posted online today. the website is designed for cheaters, act about

what is the fda doing?ple. >> nutrition labels were born in 1993. the issue is that our eating habits and the nutrition science has really evolved since the 1970s and '80s which is what we based our current nutrition labels on. what the fda is trying to do supp date our labels and make them more realistic and more like what we eat today. by law, the new serving size in nutrition labels is supposed to reflect what we typically eat or consume, not the recommended amount or not what we should consume. so the fda is basically having to revise these nutrition labels. they think or estimate about 17% of packaged foods may need to have their serving size updated. >> why might this backfire? >> the concern is people may misinterpret it and think actually a bigger serving size means that's what they should be eating. >> that's a problem. we have an obesity problem here already. aren't we telling people it's okay to eat more? >> hopefully not. that's what it should be, education-wise. the fda is trying to help us cur

it has approve from the fda. >> anne makovec joins us now to let us know what it means for consumers. >> reporter: it's not an end all be all but it means options for women. the new drug that many are calling female viagra. experts say that's a misnomer because unlike viagra it increases sexual desire rather than just treating a physical problem. it is now widely known as the "little pink pill." and it's only approved for premenopausal women. it's used to treated hypoactive sexual desire disorder, a lack of sexual desire. it targets the central nervous system by stimulating and increasing hormones in the brain. it's actually in the same category as antidepressants. the fda rejected the drug in the past because of its side effects including severely low blood pressure. >> this drug can cause sudden unconsciousness, um, it can cause nausea and sedation and excessive sleepiness. >> reporter: the new label comes with a warning saying that combining it with alcohol could be dangerous. according to a study done in 2002, as many as one in three win have low sex drive. >> this evens the score

the judgment the fda makes on risks and benefits is just that. a judgment informed by science but it ethically has the reflect the end user. it needs to be stratified to account for the individual patient's determination of benefit-risk, their tolerance for the disease, their tolerance for existing treatments. huge opportunities to get that information into the label that this is not a substitute for the current regulatory approval process. it is adding additional data that would go into the the labeling, come out at the back end, so that when i meet with my doctor and tell them what is important to me, they can determine from among multiply treatments which one will address what i want addressed. huge opportunity. huge consensus in the pharmaceutical sector. this is a huge opportunity for win, for congress to remove some barriers and encourage the fda to move forward in changing the culture to make this a reality. the second issue i would like to address deals with insuring that treatments for unmet medical needs a developed. they were first all

as i said, it had not been approved by the fda.th an advocacy group that helps, i guess, to make this possible? >> science made this possible. an expert panel was assessed -- assembled by the fda and avoided 18-6 for approval looking at scientific evidence. when they have asked us to do additional clinical work, we do it. in terms of advocacy, we are one of 26 members in a coalition effort that was designed to change the conversation. center ofecame the the conversation and much of the credit goes to the fda. what is different about this formulation that was rejected twice for? -- twice before? >> not by formulation but by scientific unders banding -- understanding of more data, more trial, more evidence that would make us comfortable that would inform patients and providers. pimm: in terms of paying for this. how much does this cost? how do you take it? handled by be insurance? >> you take it once daily at bedtime. it is a little pill. we look at other viagra like drugs, 70% of men with insurance have those covered and about $30 t

. >>> fda gave approval to a drug it's rejected twice before, known as female viagra.say it will be a game changer for women. carolyn tyler is in the newsroom with more. >> reporter: well, men have the little blue pill, now, women will have the little pink pill as the fda approved a prescription drug for women with low libidos. dr. millhauser says it's an historic moem for women. she estimates one in ten suffers from the disorder. her patients are calling and asking for the so called female viagra. >> this is a condition where women, no matter what they try, cannot find that desire. >> reporter: millhauser conducted landmark research that found the brains of women with the disorder are different. she believes the new fda approved drug known as addi effectively targets the chemical imbalance. >> the data speaks for itself. people doubled the amount of sexually satisfying events. >> reporter: the fda advisory panel heard women who want the pill and receive aid letter of opposition, signed by several health care advocacy groups, including san francisco's breast cancer act

they said to the fda, you need to study this more. the fda has been studying since 1978. that's how far you get into with the government. a lot of the big service companies who are moving. that's why we are hearing about tyson pulling away from antibiotics in the chicken and all the big farms pulling away from crates. the government hasn't budged but the big companies are aware, you know, they risk public backlash, and so government i would say forget it. i mean, the department of the environment had to be sued in order to just carry out the law, to be sued, you know. des moines, iowa is undrinkable because of agriculture waste. okay. did you have a question here? in the back then. >> i had a follow-up comment about there is federal legislation that has been introduced in the senate and the house to band an trk ibiotics in animal agriculture. it's sort of happening. >> it's very good. the bill has been put out in the main sponsors, she's a congress women in the buffalo, new york area. she's been putting this bill forward for years now. little more support each time. you k

fda want it tough to be got. trained physicians will be allowed to write prescriptions for the pill. >>> back in july, we first reported ashley madison, infidelity site, was hacked. hackers made good on the threat. they reportedly posted stolen customer dataline yesterday. 32 million users going back to 2007. it includes people that paid $19 to have percsonal info scrub ed from the site. the hackers said in part, time's up. we have explained the fraud, dispute and stupidity. now everyone gets to see their data. the data dump was posted to the dark web accessible through the tour browser. it includes customer names, street addresses, payment transactions but no credit cards. according to the security site, they spoke to sources that say this data dump is quote the real deal. >>> a close encounter caught on camera. take a look at what researchers captured, a seal followed closely by a great white shark. the shark tries to eat the seal, but the little guy manages to get away in the nick of time. it was filmed by the

. >>> kim kardashian may be in hot water with the fda. the federal agency warned the drug she posted is wrong. the fda says it fails to communicate risk information. now, kim kardashian was paid by the drug company for that post which garner eed 450,000 likes. fda wants the correction on kardashian's account which has 42 million followers. >>> let's get down to business with landon dowdy. >> good morning betty. the market could be headed for losses following china's surprise move to reduce currency. it's sparking worries they may be many worse shape than previously thought. stocks have big exposure in china following apple and young brands, kfc. >>> trucks from mexico to ohio. ford is in contract talks with uaw. >>> facebook is reportedly working on a twitter-like app that lets media outlets send breaking news alerts. alerts would be sent out like tweets with links to articles. facebook is declining to comment. back over to you. >> already. thank you so much. >>> new developments in the arlington police shooting of the college football pl

stay tuned to abc7 for the fda ruling later on today. seven is on your side with a consumer alert on the irs hack. the number of americans potentially affected has jumped 334,000000 in may potential victims today. it is not just names -- dates of birth and social security numbers stolen. other information on tax forms such as salary, places of employment, where they live, whether they are married and if they have children also at risk. sources say the information stolen from the irs will allow someone to potentially get a loan, buuy house, car, even file for tax refunds posing as a victim. undereach remains investigation could two women are said to make history on friday when they graduate from u.s. army ranger school. they are the first women to , turning as same their male counterparts. in turn sends the right to wear the rangers -- earns them the right to wear the rangers patch on the uniform. secretary of defense -- carter will decide in january whether to open all -- ash carter will decide in january whether to open all combat roles