daniel shultz resigned from the fda. 's that lobbies the fda to get medical devices approved. shultz declined comment. his company says it does not lobby as defined by the lobby disclosure act of 1995. the green leaf website says it prepares device meetings and seven fda officials. we asked gottlieb, a former fda commissioner at the fda, if close ties are compromising their mission. in your estimation is the fda more watchdog or more lap dog? >> i think the fda is pretty rigorous. >> reporter: gottlieb said ethics and a commitment to protecting principles. >> i think they do by and large a very good job. they're probably the best regulatory agency around the world. >> reporter: the fda is spending millions to update its system for recording and analyzing problems with medical devices. the essure birth control device does not have an abnormally high rate of miscarriages and the patient deaths. >> more investigations mean more answers. if you have something you think new york's biggest i-team should look into, call us at 866-639-7244. >>> we've got some breaking news right now.

y the fda counts fetal deaths reported by bayer. according to the agency's reporting rules, dd miscarriages are not deaths. >> i don't think they counted all the fetal death, all the ing about reporting rules. >> he call ed me, sai h died. >> yesterday, we told you about family of shelley, an epilepsy patient who died after claiming this nerve stimulater implanted below the neck caused painful shocks. since her death, her loved ones learned cyberonics, the make s of deaths, but classified them as less serious injuries and malfunctions. they both say their products have helped tens of thousands of epilepsy and birth control patients. they insist they have reported safety issues in compliance with fda rule, but the way the rules are ininterp and enforced maybe the problem according to michael fitzpatrick. he said the fda seems to be allowing medical device companies to decide for themselves when a death is related to one o misreporting or companies, to find i think the f sai s in best patient deaths could be correctly classified as le

trials and the fda can really be the hero here. it can help to bring competition into the marketplace by prioritizing the generic drug reviews in front of it for those drugs that don't already have a generic drug in competition. imagine if there were o or more competitors to mylan's epi-pen. we'd be in a much different situation so the fda can by rerating the resources and prioritizing the file in front of it, it can be a hero to this type of process by bringing more generic drugs to market, greater access and higher quality. >> competi of t solution here. there are critics, peter, who would say, number tha fda moves too slowly in giving signoffs on generic competition. would i like to have you address, that and, second, that the owners of the branded or innovator drugs, this epi-pen was hardly an innovator drug by the time myl ha n it, by the way. they acquired it from the german subsidiary, german merck. there are those who would say the owners of the branded drugs do not make it easy for the generics to get in. comment on that a

>> i blame the fda. i feel like they are supposed to be the >> reporter: the fda says it has analytical tools to spot deaths even if not labeled as deaths. it says it does not prioritize safety reports solely on the basis of the death, injury or malfunction category but labels do matter. in 2010, an inspector general report found only 10% of malfunction reports are assigned >>> more investigations mean more answers. if you have something you think new york's biggest i-team should look into, call us. >>> a new twist in the battle between hulk hogan and a popular website. >>> a local company is joining the fight to stop the zika v >>> janice is here with more on our exciting announcement. >> today we are unveiling a state-of-the-art storm tracking tool like you've never seen before. dave price is standing by with storm ranger 4. >> i'll bet you've never seen a vehicle quite like this before. this is storm ranger 4. allowing us to track the weather wherever it is in detail like we've never seen it before. i

we asked the fda about those reports and more. a spokesperson said the reports were likely classified correctly. >> the fda says this is not a problem. what do you say? >> i think that when you have a lot of patients being injured and a lot of deaths occurring, that it's always a problem. >> reporter: the family of shelley willheight sued the company whose parent company is publicly traded. but that company has effective immunity from liability suits because the nerve stimulator was approved through the fda's most stringent process. the fda says they're allowed to classify a parent fatality as an injury if there's not enough evidence to show causality. they say they can spot deaths even if they're not labeled as deaths. >> so chris, who is doing the categorizations here? is it a physician, is it a company individual? >> reporter: that really is one of the major questions here. and the critics would point out, most of the time it is actually the manufacturer that writes these reports and has the discretion to decide whether a devic

. >> and it is an fda roadblock. an fda slowdown in the process. >> right. fda has rejected this product. >> all right. meg, stay right here. let's bring in managing director at btig with a buy rating on mylan stock with a $60 price target. tim, why are you sticking by this buy rating? we've seen what regulatory scrutiny has done to past drug stocks before. and then if you add on top of the increases we've seen in epipen, your colleague at wells fargo points out there are numerous mylan drugs that were increased by almost the same order of magnitude as the epipen. and then add to that the fact the ceo's compensation between 2007 and 2015 was increased by 671%. optically this does not look good. >> hi, melissa. so, you know, mylan actually is predominantly a generic drug company, about 90% of their revenues come from generic products. they're one of the largest companies in the united states and globally in that field. epipen, while it's getting a lot of scrutiny on the pricing is actually only about 10% of their tota

erik: why not just inform the fda?arson: there is precedent for, there is a research who identified flaws in an insulin pump. heinformed the fda and became frustrated because nothing happened and he went public. i think the fda, it sounds as though they are more concerned about cyber security and more attuned to the risks, but i've never dealt with the fda. we feel it is important that users know and we do not necessarily have confidence in saint jude and maybe even some of the institutions of government that the right thing is going to happen. large company, very political connected. it could bring a lot of pressure to bear on the fda if there was a private backed channel discussion. this is just the real world here. erik: how many people are at risk? the number ofde's implantable device users, we do not know how many still have devices, but over the past, since 2008, looks like there have been in the u.s. about 1.1 million of these devices implanted. that's including crt's. i want to make clear, people really should

is that the fda's fault? >> i think it's the fda's opportunity to prioritize these types of propositions. >> well, to michelle's point, teva had a product last year rejected in november of 2015. and the fda pulled sanofi's competing product called avi -- >> it has dispenser issues. >> two more facts in europe where i think the regulatory burden is far higher than anything we've ever seen in the united states, there are two competitors to the epipen. why aren't they here? >> there are two problems, first when you don't have only just one player in the game, the cadillac product, you risk shortages. especially when the fda shuts down production facilities. more importantly when the fda doesn't prioritize these types of applications and doesn't help the company succeed and teva is a great example world class company they know what they're doing, you're allowing the company to do the wrong thing. the interesting thing, heather bresh, president of mylan, she's the daughter of senator joe manchin. so hopefully labo

erik: how about the fda? why not just inform the fda?son: you know there is , precedent for, there is a researcher named billy rios who identified flaws in an insulin pump. he informed the fda, and he ultimately became very frustrated because nothing happened, and he went public. now i think the fda, it sounds as though they are more concerned about cyber security , and they are more attuned to the risks, but i've never dealt with the fda. and again, we feel it is important that users know, and and we don't just necessarily have confidence in saint jude and maybe even some of the institutions of government that the right thing is going to happen. i mean st. jude is a large company. i am sure it is very politically connected. it could bring a lot of pressure to bear on the fda if there was a private back channel discussion. i mean, this is just the real world here. we did not want to risk that. erik: how many people are at risk? carson: i meancarson:, st. jude's -- the number of implantable device users, we do not know how many still have

erik: why not just informed the fda?n: there is a researcher named billy rios who identified flaws in the insulin pump, informed the fda, and became very frustrated because nothing happened and he went public. fda, it sounds as though they are more concerned about cyber security and more attuned to the risks, but i have never dealt with the fda and again, we feel it is important that users know, and we do not necessarily have confidence in saint jude and maybe even some of the institutions of government that the right thing is going to happen. saint jude is a large company. is very politically connected and could bring a lot of pressure to bear on the fda if there was a private channel discussion. erik: how many people are at risk? carson: the number of implantable device users, we do not know how many still have devices but over the past, since 2008, looks like there have been in the u.s. about 1.1 of these devices implanted including crt's. people should really read our report because there is important detail that we

if anyone needs to be investigated it's the fda and why these competitors have been blocked by the fda. >> and jonas, this company, mylan, has spent tons of money on lobbying and marketing to create an iconic brand. people ask for the epipen like they buy band-aids. doctors prescribe the epipen. >> it's an injectable $1 drug they're selling for $500. the bottom line there's a little right and wrong on what everyone is saying. the drug is cre very complicated and the drug companies have been running like hedge funds, do sleazy stuff and buy a cheap drug no one making it for a while charge a lot for a while they have a few years on the patent, it was cheap and no one wanted to make it. valeant, the skir rely guy, that guy is crooked. all because the government creates a monopoly with patents on drugs and device patents. if there was no government which everyone seems to think we want. >> i don't. >> because it wouldn't work. i love huge government. >> there was no patent protection you wouldn't spend any money to make a drug because everyone would make it for a dollar after you make it.

we have shared our formulations and ingredients with the fda it says. we exceed the fda requirements for cosmetic manufacturers. and have always been transparent. the fda disagrees saying. the company did not address safety concerns related to hair loss. we do not know if the company has other safe tie data. authority to require a cosmetics firm to provide product safety information. no authority because under a law that has been in effect since 1938, the fda has limited power to regulate the $62 billion cosmetics industry. >> we are talking baby wipes. toothpaste. deodorant, shampoo. >> a representative with the working group. >> there is no legal requirement a company make sure the product is save. >> how is that possible? >> fda has no legal power to get those. >> meanwhile, wen products remain on the shelves. the company says, the truth its that there are many reasons why people suffer from hair loss. but using wen its not one of them. as the for the lawrences, they are now part of a class action lawsuit. jericka duncan, cbs news, washington. >> sti

we have shared our formulations and ingredients with the fda, it says. we exceed the fda's requirements for cosmetic manufacturers and have always been transparent. the fda disagrees, sayinhe company did not address safety concerns related to hair loss. we do not know if the company has other safety data and we do not know have the legal authority to require a cosmetics firm to provide product safety information. no authority, because under a law that's been in effect since 1938, the fda has limited power to regulate the 62 billion dollar cosmetics industry. >> we are talking baby wipes, toothpaste, deodorant, shampoo. sigerton is with the environmental working group. >> there is no legal requirement that a company makes sure a product is safe before they sell it. >> reporter: how is that possible? >> fda has no access to safety reports. they have no legal power to get those. only congress can give them that power. >> reporter: meanwhile, wen products remain on the shelves. the company says the truth is that there are many people why people suffer from h

fda approval has been the problem here. tefa put out a short filing with the ftc saying they identified certain major definitesies and teva expects the product will be delayed and any launch will not take place. as teva was applying for that approval mylan sent a approximate he tissue to the fda telling them the epipen generic needed to be the same as the actual epipen and not require additional training. what mylan said they believe because of the nature and scope of the differences and design in operating principals, epipen trained users will not be able to safely use the teva product according to the instructions for use. they say the issues raised by the teva device are novel and involve significant potential health risks to patients. subsequently the teva generic was rejected. now there's pressure put on the fda as to why this hasn't been approved and why there's a ba backlog of these competitions. senators have written a letter saying it would be helpful to understand the food & drug administrations role in this area

>> why not in from the fda? : there is precedent for -- there is a researcher who identified flaws and an insulin pump and and from the fda. he became faster -- insulin pump and informed the fda. he became frustrated. i have never dealt with the fda. again, we feel it is important that users know. we don't have confidence in st. the, and maybe even some of institutions of government that the writing is going to happen. large company, i'm sure it is very politically connected. i'm sure i can bring pressure to bear on the fda if there were back channel discussions. it can bring pressure to bear on the fda if they were back channel discussions. >> how many at risk? carson: we don't know how many still have devices. since 2008, it looks like there have been 1.1 million of these devices implanted. that is including crts. people should read our report. there was important details that we can't get into. is, one of the things that important is that they tested both. the same communication protocol. because of lack of d

the fda disagrees, saying, the compand concerns related to hair loss. we do not know if the company has other safety data and we do not know have the legal authority to require a cosmetics firm to provide product safety information. no authority, because under a law that's been in effect since 1938, the fda has limited power to regulate the 62 billion dollar cosmetics industry. >> we are talking baby wipes, toothpaste, deodorant, shampoo. sigerton. >> there is no company wide product to make sure a product is safe. they have no legal power to get safety records. only congress can give them that power. >> reporter: meanwhile, wen products remain on the shelves. the company says the truth is that there are many people why people suffer from hair loss but using wen is not one of them. as for the lawrence's, they are now part of a class action lawsuit. jericka duncan, cbs news, washington. >>> coming up after your local news on "cbs this morning," truth in politics. we speak with "the washington post" fact checker columnist glenn kessler who point out lies

"we have shared our formulations and ingredients with the fda,"th it says, "we exceed the fda's manufacturers and have always been transparent." the fda disagrees saying the company did not address safety concerns related to hair loss. we do not know if the company has other safety data and we dot not have the legal authority to require a cosmetics firm to provide product safety information. no authority because under a law that has been in effect since 1938, the fda has limited power to regulate the 62 billion dollar cosmetics industry. >> we're talking baby wipes, toothpaste, deodorant, shampoo. >> reporter: attorney tina isir with the environmental working group. >> there is no legal requirement that a company makes sure a product is safe before they sell it. >> reporter: how is that possible. >> they have no access to safeta records, no power to get those. only can give them that power. >> reporter: meanwhile wen products remain on the shelf. the company says the truth isns there are many reasons whyr fr people suffer from hair loss. as for the lawrences, they are law part of a class acti

in all eight funnel clouds were spotted in the state. >>> the fda has approved a new lens for people who suffer from cataracts. as kenneth craig reports, it's giving patients back their natural vision. relies on his eyes for work. he says his vision changed about a year and a half ago. >> i started to notice some shadowing, especially driving at night. my long distance vision was impaired and i was having more and more trouble reading close-ups. >> reporter: the 65-year-old was diagnosed with cataracts, a clouding of the lens of the eye. >> the lens is completely out now. >> reporter: his doctor recommended surgery to remove his old lens and replace it with the new fda approved one called the symphony. unlike previous options, the lens from abbott can improve vision at near, intermediate, and far distances and points in between. >> a brand new category of lens that gives patients continuous vision and reduces their dependence and many times eliminates their dependence on glasses. >> reporter: bruce was the first to get the lens since it was fda proofed. vision where they are less dep

fda has no access to safety records. only congress can give them that power. >> reporter: meanwhile, wen products remain on the shelves. the company said as for the lawrences, they are now part of a class action lawsuit. jerika duncan, cbs news, ,,,,,,, ♪ >>> a full moon shown last night over the olympic stadium in rio. but jaime found something brighter, six feet of sunshine. >> it's over. the united states has won the bronze. >> reporter: she has three gold medals from the last four olympics and five shoulder surgeries to make all that possible. >> i literally don't know how she does it. >> april ross is her beach volleyball partner. does she need an action figure? >> she is literally a super hero. >> reporter: kerri walsh jennings has a nickname, six feet of sunshine. she's quickly become one of the superstars of this olympics. >> make no mistake, no one wants to win more than her. >> reporter: friends point to her strejt and maturity as the oldest winner in beach volleyball history. but as jennings has always said he

>> other day in the fda? and then somebody will be sent out to kill you. [laughter] they do a lot of good things if they approve the job -- the drugs rapidly but cancers are special it is the most curable chronic disease and also the most fatal those that died don't want to wait 10 years for the next new drug to come along. so they tend to rely on comparing and survival which is very difficult under the circumstances but it should be proven it is safe and if it hits the biologic target if it can pick up those mutations most of the defense is that we talk about were done in the post marketing period so we should give these tools and let them use them to come up with the new ways to cure cancer. the way to do that is to hit the target then delete the early trials for what we call phase one and phase two studies. the fda could retain the right to come in and on it but if you set up a protocol and somebody wrote a paper in some cases it will take 800 days for a protocol to be approved. and it goes through a couple more committees you go back to the system we d

the fda says 11 states should put testing in place within the next 4 weeks. they are: alabama, arizona, california, georgia, hawaii, louisiana, missisippi, new (dr. peter marks, director, fda's center for biologics evaluation and research) they are either adjacent to areas where there's local transmission of zika //in some cases they are states that have had large numbers of travel associated zika the rest of the country has 12 weeks. (don champion/cbs news) earlier this year the fda advised blood banks nationwide to turn away donors who had recently traveled to areas where zika is spreading. the fda confirms one donation tested positive for the virus in florida and others are d vtation.(dr. peter marks, director, fda's center for biologics evaluation and research) that donation was identified while quarantined which means its prior to being released by the blood bank. there have been no reports of transmission through blood transfusion in the us. don champion, cbs news, dallas. ((christianne klein)) >> most people don't have symptoms from zika. but pregnant

>> fda has no legal power to get those. only congress can give them the power. >> meanwhile, wen products remain on the shelves. the company says, the truth its that there are many reasons why people suffer from hair loss. but using wen its not one of them. as the for the lawrences, they are now part of a class action lawsuit. jericka duncan, cbs news, washington. >> still ahead, the first flight for the world's longest aircraft. ! polo! ..! polo! scusa? ma io sono marco polo, ma... marco...! playing "marco polo" with marco polo? surprising. ragazzini, io sono marco polo. s?, sono qui... what's not surprising? how much money amanda and keith saved by switching to geico. ahhh... polo. marco...! polo! fifteen minutes could save you fifteen percent or more. polo! oh, dishwasher, why don't you dry my dishes? d compartment. it's there for a reason. it dries much better than detergent alone. sorry dishwasher. finish? jet-dry?. for drier, shinier dishes. discover new magnum double raspberry. made with the perfect balance of raspbe

that was probably due to the fda.nies right now trying to get their product onto the market and the fda is demanding more tests and data. >> i guess the argument would be, bill, never mind that -- >> true. >> i think that's irrefutable. still, it's immoral. >> they can do it without competition. we have to get back to the essential truth. the opposite is not cooperation. it's collusion. that's what we'reeing. congress doesn't lower prices. competition does. what joe is saying is that what the fda does is take the model of the epipen and -- like the taxi limousine and the costs are so high. but to raise prices and even though there's a protected monopoly, let's face it, do we really need to charge 500 bucks for these things, james? >> we were talking about regulatory anxiety. there's a treatment for this. it's free markets. we don't have to rely on the ceo to be a very nice person or not. people talk -- like hillary clinton, talk about how he's a policy wonk. she gets to the back of every briefing brooke. we've been th

... and the acid reducer lasts up to 12 hours >> quijano: the infomercials are all over tv, now the fda is investigating the hair care product they're trying to sell 'r here's jericka duncan. >> reporter: these are pictures of 11 year old ileana lawrence two years ago. >> i was scared that i wasn't going to get my hair back. >> reporter: her mother mirrian said ileana went nearly bald after using a wen by chaz dean hair care products. >> i tried wen and wow. >> reporter: it has celebrity endorsements and boasts a stronger, fuller hair. but not for ileana says her mom. >> i noticed that her hairbrushm was overflowinth >> reporter: the fda beganwa investigating the company after reports of hair loss, balding and rashes. last month the agency took the rare step of issuing a safetyof alert after learning the company had received 21,000 complaints. the company tells cbs news it is cooperating and its products are safe. "we have shared our formulationo and ingredients with the fda," it says, "we exceed the fda'sit requirements for cosmetic an the fda disagrees saying the f company did not add

the fda is ordering all blood donations in the u.s. be tested for that virus. more than 2200 americans have come infected with zika and the number may grow. anna-lysa gayle has how this will affect blood donations. anna-lysa: leon, this is another preventative measure we are seeing as officials try to stop the spread of the virus through the country. the fda recommendation coming on the same day the cdc announced that a maryland man who displayed no symptoms transmitted the virus to his sex partner. affectnow that they can young born fetus, and it's worth testing. anna-lysa: fda recommends all blood donations across the country should be tested for the zika virus. >> i would say it's a good idea. anna-lysa: an expansion on screening beyond puerto rico, where there is active zika transmission. a spokesman for the red cross said the organization will follow the fda recommendations. over the next two weeks, they will expand testing to four additional states in the south central and southwestern u.s. this is the chief medical officer for america's blood center, a n

we shared ingredients with the fda, we exceed the fda requirements and have always been transparent. the fda disagrees saying the company did not address safety concerns related to hair loss. we don't know if the company has other safety data and we don't have the authority to require a firm to provide product safety information. >> there is no legal requirement a company make sure it is safe before they sell it. >> only congress can give them power. >> reporter: products remain on the shelves. the company says there are many reasons why people suffer from hair loss. they are now part of a class action lawsuit. cbs news washington. >>> tonight something you rarely hear from donald trump. regret. listen. >> sometimes in the heat of debate and speaking on a multitude of issues you don't choose it right words or you say the wrong thing, i have done that and believe it or not i regret it. >> meanwhile hillary clinton told the fbi that colin powell advised her to use a private e- mail server according to the new york times. he used his private e-mails during his tenure as secretary of sta

>> fda has no legal power to get those.nly congress can give them the power. >> meanwhile, wen products remain on the shelves. the company says, the truth its that there are many reasons why people suffer from hair loss. but using wen its not one of them. as the for the lawrences, they are now part of a class action lawsuit. jericka duncan, cbs news, washington. >> still ahead, the first flight for the world's longest aircraft. nology. technology... say, have you seen all the amazing technology in geico's mobile app? mobile app? look. electronic id cards, emergency roadside service, i can even submit a claim. wow... yep, geico's mobile app works like a charm. geico. expect great savings and a whole lot more. that's why i bought six of you... for when you stretch out. i want you to stay this bright blue forever... that's why you will stay in this drawer... forever. i can't live without you. and that's why i will never, ever wash you. protect your clothes from the damage of the wash with downy fabric conditioner. it not only