fda's generic's work load? >> yes. this chart shows the entire work load at almost the current time. at the top, the 620 is all the applications we've had to deal with the bottom number, 600. those are the ones that haven't entered review yet. it's only 10% that haven't entered review. some of those were submitted recently. 2400, we're in the stage of back and forth with companies. so we're going back and forth. we're trying not to have these multiple cycles like we had in the past. try to get to a first cycle approval. >> so when people say backlog, it's not like the drug is sitting there, nothing is happening to it? it's part of the backlogt it's withdrawn by the company or you're going back and forth with the company? >>. >> this is simply the overall work load. the backlog was something that existed at 2012. >> in the future, we're not going to have any backlogs. if we have 1,000 drugs submitted a year, they won't be in backlog, they'll be moving down the process. because we have a lot of them that don't ha

we wish the fda would do more of that. but we did at the goldwater institute under the freedom of information act we asked the fda to tell us about the decision-making process they use to judge that the bowler was such an emergency that all the rules and rexroth a table that they could immediately give some into people even though it had never been tested in human beings before mlb's patients with terminal illnesses can't access medicines that could save their lives. jen mcnary, the mother we talked about with the two boys with muscular dystrophy said, you know what, and dmd is an emergency to my son and that is a fact. it is an emergency. it is the same of ebola. your life is on the line. the fda refused to share their decision-making process and we've taken him to court to force their hand. the fda right now has the power of life and death over americans citizens and regardless of what you think about the right to try are the policies i might be promoting today, the american people have a right to know how the fda is mak

this is a fda-approved product... >> narrator: dr. preston mason is a harvard university researcher. here, he's comparing prescription-quality fish oil to the oil found in over-the-counter supplements. >> and give it a smell. >> it smells a little bit fishy, but not bad. >> right. you're gonna have always some smell. >> narrator: one of the issues with fish oil is it's delicate. it's extracted as a byproduct from oily fish like anchovies. as the fish get crushed, the oil is exposed to oxygen, and it doesn't take much oxygen to turn the oil rancid. >> this is a common supplement for fish oil. see what that smells like. >> oh... >> what? >> that doesn't smell good. that smells like it's going bad. >> yeah, right. it's a very strong fishy smell. >> narrator: if it was simply an odor issue, that would be one thing, but oxidized oil contains oxidized lipids, one of the building blocks of cells. we've long known that lipids, when oxidized, can be harmful. >> so an oxidized lipid triggers inflammatory responses within our body, particularly

it's based on similar agreements with other manufacturers and the fda. congress anticipated that generic drug facilities abroad would be brought up to the same standards as facilities in the u.s., too, that american patients would benefit from faster approval of generic drugs and those two actions together would create more competition lower the price for the drugs. but as i mentioned in 2012, there was a backlog of 4,700 pending applications and the information we have shows that that's dropped to 3,500 applications. the hhs inspector general has reported that the fda's improving its inspections abroad, but the troubling news is that it seems to take fda longer to get generic drugs through the approval process. the approval times -- the median approval times have slowed from 30 to 48 months. and the original number hoped for was 180 -- 180 days. as we discuss these issues today, i think it's important to keep in mind that drug pricing is a legitimate, real concern of americans, but it's part of a larger concern of rising health care costs. congressional

the fda yanked 23andme products off the market. this as ceo anne wojcicki had to face a very public divorce from her husband, google co-founder sergey brin. two years later, wojcicki and 23andme had made a remarkable comeback with its first fda approved consumer product, new funding and a $1.1 billion valuation. joining me today on "studio 1.0," 23andme ceo and co-founder, anne wojcicki. anne: thank you. emily: it's so great to have you here. thanks for doing this. anne: yeah. any time. emily: the last two years for you have been crazy. it could have been disastrous for the company. but now you are back on good terms with the fda. how do you feel about where you are right now? anne: i feel great, like i'm super proud of the company and what we have accomplished because i think when you have to slog through and you just have to put your head down. that when there is a lot of work ahead of you and you're not going to see a reward for a couple of years, it's hard. i almost feel like we just climbed the first flight of stairs, but we'r

of the fda and about the need for there to be a new track in the fda for drug device combinations, and this committee is obviously looking at that. what can you tell me about where the fda is in terms of making a recommendation to us on what the drug device combination would look like? what is your recommendation to us for that? >> well, i believe that the fda is ready to work with the committee on this and we are very interested in looking at some solutions to this problem. >> have you proposed any? >> i don't know that we have proposed specific legislation and i don't know where the administration is on that. however, i would say from my own technical point of view that it is a problem. we need more clarity. we probably need a different path -- >> both you in charge of the drug side and the device side have both said the same thing to me which is you can't do drug device combinations using our process. there's got to be a new process that emerges. do you think it would be wise for you and the device side to sit down and make a recommendation to us as to how you think the drug device

♪ emily: i do want to talk about your dealings with the fda. what do you think about elizabeth holmes? and the situation that is unfolding. anne: i have spent a lot of time with her. i have a lot of respect or her mission and what she is trying to do. i have stayed out of knowing the details of it. i think health care is changing quite a bit. people are always going to be skeptical. the onus is on us to be very transparent. emily: i understand what she is trying to do. it is hard. after 12 years, should it be more involved at this point? anne: i can walk into any center and i don't need a physician. i can just get my information. i think people just want to see and understand the technology and understand the data. i gets that concern. people are making life-and-death calls based on this data. they want to understand the why. emily: this is a $10 billion company. people think it is a fraud. do you think it's a fraud? do you think this is possible? anne: i'm sure it's possible. everything i know, she works incredibly hard. i have seen her discip

we had conversations about the device regulating side of fda and the drug regulating side of the fda and the need for a new track for drug device combination and this committee is looking at that. what can you tell me about where the fda is in terms of making a recommendation to us on what the drug device combination would look like? what is your recommendation for that? >> i believe the fda is ready to work with the committee on this and we are very interested in looking at some solutions to this problem. >> what do you propose? >> we have not propose specific legislation and don't know where the administration is on that but i would say from my own technical point of view that it is the problem. we need more clarity, we need different paths. >> in charge of the drug's side and device side both said the same thing to me which is you can't do drug device combinations using our process. there has to be a new process that emerges. you think it would be y s 4 you on the device side to sit down and spend time making a recommendation as to how you think those drug device combinations migh

but now, your back on good terms with the fda. how do you feel of how your right now i'm super proud of the company. when is a lot of work ahead of you and you're not courtesy a lot of rewards for a couple of years, it was hard. i feel agree are still climbing the empire state the link. there is a lot more to go. we are back on the market. product.n incredible we completely redesigned everything. i'm excited this is the first chapter in the book. >> you have the first fda your.er approved test consumers can get test without going through a genetic -- it for is a test that recessive genes, things you can pass on to your kids. also other things, like i color. it teaches people about genetics and metabolism. love if you could take me back to the day when you got that letter. we were all in great moods here at wit hired a great number of people. moment howafter that much there was a disconnect between what we saw and with the fda needed us to do. >> did you think you could lose the company? >> is probably about a six week time. where

>> fda's only got one it's john q. public to protect the american public from safety and effectiveness. >> reporter: senator grassley told us the fda's response was incomplete. he had more questions as he decides what steps to take next. once again, bard declined our request for an on-camera interview, but told us while all medical devices carry some risk, its filters are an important clinical option for physicians, and that the company steadfastly believes in the safety and efficacy of these devices. >> we were lucky we got the bulk of that filter out. >> reporter: four days after chris' emergency surgery, he met with dr. coe for a follow-up. >> this is a filter we removed. one of the broken arms is at the bottom of the jar. >> reporter: a patient grateful to be saved from a filter he thought was saving his life. you seem shaken to me. >> it's very difficult could have missed it. >> reporter: you caught it. >> luckily. did not answer our recovery and g2 filters were not recalled. the agency says it investigated the ri

he sued the fda. might we see action? john: sure, the context around this, the fda has been working on these voluntary guidelines for the industry. a couple of years ago, they said they expected to issue them -- they were expected to do that by the end of 2014. here we are in 2016. obama's term is at its end. and jacobson is saying, listen, we need to get them to act on it. so, his group filed a lawsuit, asking the fda to act on salt limits. so, the regulator has until sometime in february to respond in court. carol: not everybody agrees there is a problem. you talk about the flipside in your story, people saying it is not really an issue. john: one thing is the science on sodium intake is complex. you know, science is not open and dry. there is some evidence that says lowering salt intake beyond a certain level could be harmful. americans are not near that level yet. but, you know, there are people making arguments saying, you know, that generally we are at a safe level of sodium intake. and when you talk to doctors, pub

he sued the fda. might we see action? john: sure, the context around this, the fda has been working on these voluntary guidelines for the industry. a couple of years ago, they said they expected to issue them -- they were expected to do that by the end of 2014. here we are in 2016. obama's term is at its end. and jacobson is saying, listen, we need to get them to act on it. so, his group filed a lawsuit, asking the fda to act on salt limits. so, the regulator has until sometime in february to respond in court. carol: not everybody agrees there is a problem. you talk about the flipside in your story, people saying it is not really an issue. john: one thing is the science on sodium intake is complex. you know, science is not open and dry. there is some evidence that says lowering salt intake beyond a certain level could be harmful. americans are not near that level yet. but, you know, there are people making arguments saying, you know, that generally we are at a safe level of sodium intake. and when you talk to doctors, pub

known. >> the fda's got only one spopgs. it's not the company. it's the public. >> reporter: senator grassley told us that the fda's response was incomplete and he has more questions as he decides what steps to take next. he told us while all medical deviss carry some risk, its filters are an important clinical option for some physicians and the company steadfastly believes in the safety and efficacy of the devices. four days ago he met with the doctor for a follow-up. >> one of the filters has a missing arm at the bottom, do you see that? >> yes, i did. >> grateful to be saved from a filter he thought was saving his life. >> you seem shaken to me. >> it's very difficult to think that you could have missed it. >> and you caught it. >> luckily. >> that was nbc's stephanie gosk reporting. nbc asked the fda why bard's recovery and it wasn't recalled. they didn't answer. they say they've investigated everything and organized a long-time critical trial looking at the safety and effect of those currently used. >>> coming up, why w

the fda committee plans to announce the results of a review on essure next month. an idea in europe over what to do with the dead is "growing" in popularity tonight.. an italian duo has come up with a new way to get buried. basically it puts lifeless bodies into a large biodegradable pod.... which then gets planted.. six and serves as nutrients to grow a tree above! the folks who hatched the biodegradable egg idea say they dream of cemeteries of the future looking like "sacred forests." next at 11 - you might call it karma. a mischievious dog gets in trouble after destroying a siberian husky )s foolish mistake is going viral. you re looking at the aftermath of a fight between the dog and a sofa. the fabric of the couch is torn and you can see bite marks all over. when the owner of the dog pans around the room, he sees the dogs head sticking out of the couch! while trying to catch a rodent, the poor pooch

does the fda want this out for people at high risk? >> they do. when we first went to them, we had data from the phase 3 trial, we had a very narrow timeline on when we could start the phase 3. december and goes through march or april. we had to have a meeting with the fda before the season started. so they readjusted their schedule, had a meeting with us and it allowed us to recruit these 11,800 people to start the trial. i think the fda has been very good at recognizing that we have the only rsv vaccine that's ever shown efficacy in any population. >> it is funny, stan. i'm listening. i was thinking to myself, only in this really difficult market where that kind of good news would actually be greeted with a selloff. i guess you have to keep your head down and not pay attention to the stock. >> i have the benefit of the curse of being in biotech for 30 years. i have seen these reactions. we have nothing but great data in the last six months. product, the data. we just have to keep moving forward. >> well, i think that's exactly the way people hav

the fda and the an fda needs to be over hauled. a lot is coming up out of this pizza box. > let's head over to tony andon shawn for a look at what's next on fox5 local news at 6. 6. >> it's also complicated withomp all of this. > and speaking of that, keeping with the food theme, campbell'sl soup is doing something no other major food company has done. they're making some major disclosures about their products.. we'll tell you what it could it mean for some of your favoriteao soups, vegetables, saws and juices. and your fit about it may be it more of a fit fraud.rau we'll have the latest on the lawsuit. also ahead at 6, the gun control debate is front and centerter nationwide, of course.ours why virginia gun owners are rushing to get gun permits from the state of utah. ♪ ♪ ♪ ♪ ♪ wow. the internet is crazy fast here. i know, right? it's so nice to have everyone over. hi hey. mmm. i just laid an egg. does anybody want it? joey, you want some gasoline? yes, please. mom, guess what? i married a clown and we're having tiny lit

the fda committee plans to announce the results of a review on essure next month. a 15-year old virginia teen is now the most popular kid on his street after we he did to here )s kristen crowley to help warmer with more clouds... temperatures will be warmer throughout today with numbers mainly in the 40s this morning and highs in the mid 50s this afternoon. expect more clouds today with an isolated shower possible. the warming trend continues for thursday with highs in the mid 50s. expect mostly cloudy skies again tomorrow with an isolated shower possible. highs will warm to near 60 this weekend with rain likely saturday night and into sunday morning. temperatures cool back into the 40s early newschannel threes stefania okolie is live at the extended stay of america where police are investigating an early morning shooting. got tired of waiting for winter to come to him and decided to take matters into his own hands. mason craven built his own home-made snow-maker. his parents were skeptical at first and needed a little convincing. but mason had it all worked out. o

randy: the latest warning from the fda about pizza. the super bowl halftime show is getting an upgrade. the superstar performer who will tt2w`t3n@2d" bt@q/.\ tt2w`t3n@2d" "a@q?"8 tt2w`t3n@2d" bm@q4)4 tt4w`t3n@2d"" dztq > i got it. >> the only well to tell january. cindy: we' ve got some changes coming in. hope you got your vitamin d. here come the clouds. areas of drizzle over the next 24 hours. there could be a few icy spots. so we' re watching for that. sunday is the wetter day of the weekend. we do get up to the mid 50' s in boston, which would be a record for the day. we are flirting with these numbers. it is going to be worn by the worcester, 29. boston, 30. on the cape, the wind is not coming in off the water. not dealing with any fog just yet. the could be some icy spots. notice the wind is coming in off the water in southe

the fda is another problem with innovation. i have a very dear friend of mine with ovarian cancer right now. she has stage 4. it is very serious. if you look at the therapy right now -- the highest is 25%. -- the highest survival rate is 25%. there are therapies overseas that have higher survival rates, but they're not offer because they have not been approved by the fda. she is traveling out of the country to get care for cancer. really, should that be happening in america? takedn't we be able to someone with that degree of illness and have options available to them? we do not. all that is the government saying no. so this is a big, big problem. part of the lack of innovation and improvement. the government needs to get out of the health care business, which means obamacare has to go. medicaid should be in the state so you don't have a centralized agency making these kinds of coverage decisions. each state can make them. at least you have a righty -- you have laboratories to determine what is working and what is not. medicare

the fda is? the fda is dreaming up new application for children and first super opiates? where in the heck is the congress in terms of our responsibility when it comes to this? the second point i would like to make is, the police chief and closser ought to be here today, because dixon, illinois population 20,000 went to visit with him and decided after four heroin overdose deaths in one weekend they were going to buy into his program. twenty-five kids, young people came forward. they went into treatment. you know what happened to the jail? it was empty. the petty crimes, burglaries, thefts started disappearing. but there is a creep key element here. how do they get into treatment? if they are lucky enough, if they're lucky enough to have health insurance and their families have access, if they're lucky enough to the affordable care act to have access to medicaid the may get into treatment. we all know that we do not have enough resources to treat these people. we absolutely positively have to do it. i want to commend two, we have senators from minnesota here, in a biparti

the fda cracking down on a concern chemical in your pizza box. it is meant to keep the pizza fearing it could cause cancer. dr. joe is here with more. what is in the box, dr. joe? >> what they are concerned about is these pfa chemicals. they are used as a coating to keep the water and grease penetrating through the box because nobody likes a soggy pizza box. the concern is these particular chemicals they have affects on the fetus, male reproductive system and endocrine system so because of activist they have been banned by the fda. >> what should be the concern with the popcorn in the microwave back and the pizzas that are a common dinner staple. what is your advice? >> these particular chemicals have been phased out already because companies have but there is a whole host of other chemicals these advocating groups are hoping the fda will take a look at. anything packaged, boxed or processed for the most part whether it is in something with a chemical or not is not good for us. cooking at home, using fresh fruits and vegetables, those are the thi

the fda is the label should specify the amount of added sugars in the product. and finally, some good news for coffff drinkers, the new regulations suggest a little bit of plain coffee each day is considered part of a healthy diet. live in dubuque katie wiedemann kcrg tv-9 news joe, we've seen some rain roughout the day today. what can we expect going into the evening hours? plan on more showers and fog tonight and tomomoow. temperatures, overnight, will be staying in the middle 30s through friday. friday night into saturday colder air begins to arrive ushering in some snow which looks to be heaviest to the east of the mississippi. cooler winds take over with an arctic outbreak next week, dropping highs into the single digits and wind chill values by sunday close to -20. have a great night. tonight: showers and fog low: 31-37 winds: se 5-15tomorrow: rain likely high: 34-40 we go now to meteorologis t justin gehrts who's live with our mobile weather labb a man faces an attempted murder drug charges after police say he fired six shots at another man in cedar rapid

the fda says the 8 ounce jars of "nice!" brand mandarin oranges have been recalled by the manufacturer. at least 3 customers reported finding the glass, and at least one person was hurt. if you have any jars at home you can find out if it's part of the recall by checking the u-p-c code on fda- dot- gov. there is new advice for women when it comes to getting mammograms. national experts are now recommending women get a mammogram every other year.. starting at age 50. the panel says women in their 40's should make their own choice based on their health history and risk factors. guidelines differ from various health groups. last year the american cancer society changed its recommended starting age from 40 to 45. the key to eating less may begin with the size of your plate. scientists in plates are 50 percent smaller, people eat 30 percent less. smaller plates were especially effective when people serve themselves at home. the researchers reviewed more than 50 studies focusing on plate size and eating. tomorrow is the big powerb

about 45 new molecular entities were approved by the fda. the interest by big pharma is also at a high. big pharma is looking to this industry to provide that innovation for their own pipelines. >> let's talk about that, doctor. you have a migraine prevention drug. you've got this handout that comes from this conference that is really unbelievable. rapid onset of 100% migraine prevention. this is for your ald 403. these are remarkable figures. migraine sufferers should be clamoring for this. >> in fact there is high interest in this. and i think this is really on the back of the success of the scientists at alder. they've been able to identify a therapeutic that neutralizes what we believe is the primary initiating factor for migraines and target it in a way that we can prevent migraines happening in these patients altogether. >> 36 million americans suffer from migraines. only 22.3 million migraine sufferers have been clinically diagnosed. how do you reach that population? how do you get the word out? given the data, i have to believe that

lyrica is fda-approved to treat this pain. lyrica may cause serious allergic reactions or suicidal thoughts or actions. tell your doctor right away if you have these, new, or worsening depression, or unusual changes in mood or behavior. or swelling, trouble breathing, rash, hives, blisters, muscle pain with fever, tired feeling, or blurry vision. common side effects are dizziness, sleepiness, weight gain and swelling of hands, legs and feet. don't drink alcohol while taking lyrica. don't drive or use machinery until you know how lyrica affects you. those who have had a drug or alcohol problem may be more likely to misuse lyrica. now i have less diabetic nerve pain. and i love helping first graders put their best foot forward. i wanted to earn an mba, but i didn't want to spend my time studying material i already knew. that's why i chose flexpath from capella university. its revolutionary, self-paced program let me leverage my work experience. i can move faster through material i knew, spend more time studying what i didn't, an

the fda is also reviewing the policy on blood donations as zika continues to spread. kenneth moton, abc news washington." affected regions. on-cam close: pregnant women in the us are getting refunds from airlines and cruise operators traveling to the caribbean and latin america. the fda is also reviewing the policy on blood donations as zika continues to spread. kenneth moton, abc news washington." after the break... we'll have a special guest in studio to talk to us about the dangers of radon can keep your get your home tested. dr. cynthia wolff from mercy medical center is here to tell us more. is radon lurking in your home? mercy medical center and the siouxland district health department are joining forces to increase consumer awareness of the dangers of radon gas. radon is an odorless, colorless, tasteless gas that causes no immediate health symptoms, but exposure is the second leading cause of lung cancer in the u. s. most alarming, iowa has the highest percentage of homes with elevated radon levels in the nation. each year, more than 20,000 americans lose their

but gary kubiak yak said the team needed @f@fda aberspark, so he brought in peyton manning. bros 27-20. they won it two weeks amamica fore their first playoff game, which ` gives us lots s @a[@rtime to talk about the quarterback situation. >> we have two weeks before we have to play again. i have to see how i feel tomorrow. another bye week will come and thisve the guys a ica thisance ch@cget ngi_ healthy. >> peyton sparked the team and the run game got going. the backs played great the is what it's always about. coach preaches it takes all 46 guys on game day. today that was truly ththdh@c m _amercase. am we america won the %a thh@c[@ericititerica thbeen a ad]r >> we have a lot to talk about on seven sports extra toy.ii_ we will also ngh@c americto icgary kubiak yak later today. mind. how can oo get tickets? the bros play the lowest seeded team from the wild-card games meaning they could play the texans. tickets will go on sale today at noon. you can get them in person, you can only get four per household. >>> payton manning making i@fdaa ica this comeback. but he's still d

next week sarepta goes in front of the fda. wednesday morning we'll see the briefing documents come out. friday is the day sarepta presents in front of that panel of advisors. the expectations are more positive for sarepta. folks do expect the briefing documents could be harsh. jeffries putting 70% chance of approval. approval would come later in february. baird low at 35%. i got off the phone with rbc, he is more positive, 65% to 70% chance of approval. next week will be the fda discussing this and stock moves could be big. probably negative wednesday and more positive coming out of friday. you see probably hundreds of patients in the community coming to testify and show their support for this drug. >> meg tirrell thank you so much. from 70% to 35%? >> sarepta is a volatile stock. now you find that smack dab in the middle of a range we've seen, which is interesting. big short interests, binary play, but given the two names meg mentioned, biomarin is a better play here. if i may use this phrase, it's a safer play. given the cho

the bill would allow patients to take medications that are only past by three fda approval faces. it will have completely on these folks. but it is their decision. these people are terminal. wheel -- we know the only side effect of doing nothing his death. and if they choose to make this -- take this chance, they should have that right. >> there is no downside to it. if i'm dying, give me another chance for survival. >> the bill still has to pass the senate and house before goes to the governor's desk. a similar law has been passed. >>> the public is invited to the statehouse today to give their comments and recommendations on the department of transportation. the legislative oversight committee is taking public comments to find ways to improve state agencies. it will take place in about a half-hour at the black building. >>> lawmakers face of june deadline for developing a plan to improve the state public schools so more students have a chance for success. leaders pledged to respond to ruling that poor rural students lack educational opportunities. the response will likely includ

the company says all of the ingredients are safe and approved by the fda. they say they are in full compliance of all standards and compliance regarding ingredient use and labeling. >>> she does not -- he does not will meet with the chairman of google. there is amounts -- immense it opportunity for encounter and solidarity -- there is immense opportunity for encounter and solidarity. >> he is forward thinking and wants to get in touch with people. >> he does not even own a computer. how does he get on twitter? >> i think he has a social media person. >> he does not invest in things. >> it is a cool meaning and he >>> surveying the damage caused by a fire at an oklahoma oil the damage and -- the damage was valued at $20 million. four different fryer crews had to be called in. think we no one was hurt -- -- fire crews had to be called in. thankfully nobody was hurt. >>> evaluating all potential safety issues. the fda is working hard to speed up reviews of new drugs, but fails to keep track of potential problems once they reach patients. tracking is not always

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licensed with the california department of health, and classified as a class i medical device with the fda since 1992. the back bubble is featured in medical textbooks, and used by many doctors and pain specialists and in a military medical l cility for thousands of pain-relieving treatments. in a pilot medical study, 99% of participants experienced pain, including disc problems, sciatica, , scular pain, arthritis, and other chronic back conditions. the back bubble has an average of 4.5 out of 5 stars in online customer reviews. >> i've had it now about two years, and i i pain-free. the back bubble works. >> i've been using the back bubble for seven years. the back bubble is the best thing that has happened to me. the pain goes away and stays awaw. >> i'm not a paid spokesman. i'm just a regular guy with back problems that has found a solution. >> announcer: today, we'll hear fr back-pain sufferers who tried the back bubble for the very first time. >> oh! it just relieved everything instantly. >> i don't feel any back pain. >> it feels so good. laughs ] >> i'm so happy for you! >> i want t