35 Burst results for "Commissioner Scott Gottlieb"

Could Technology Replace Animal Testing?

BrainStuff

02:06 min | 3 months ago

Could Technology Replace Animal Testing?

"In january of two thousand eighteen. You food and drug administration. Commissioner scott gottlieb announced that the agency after an internal investigation had permanently ended a nicotine addiction study in which force world monkeys had died. He said in a statement on the fda website based on the team's findings it is clear. The study was not consistent with the agencies high animal welfare standards any september twenty seventeen letter famous primate researcher and conservationist jane goodall had denounced the research as cruel and unnecessary saying that the harmful effects of smoking on humans are already known and could be studied directly in addition to ending study. Gottlieb said that the findings indicated that the fda's protections for animal research subjects quote may need to be strengthened in some important areas for that reason. He announced the launching of an independent third party. Investigation of all of the fda's animal research into the creation of a new animal. Welfare council to oversee those studies going forward. Additionally gottlieb said that the fda would strengthen its commitment to replacing reducing and or refining animal studies with new methods said that animals should be used studies. Only when there's no other way to do research that's important for public health. But even so he said it is important to recognize that there are still many areas where animal research is important and necessary in particular. He cited the use of primates as essential for the development of some critical vaccines for human children. The research involving monkeys and the response highlighted. What for many people is a discomforting reality. Despite computer simulations and other tools available to today's researchers laboratories still use large numbers of animals as experimental subjects an email. Fda spokesperson taraji. Rabins said that the agency currently is utilizing eight thousand one hundred and sixty seven creatures of various sorts in research. That includes seven thousand. Rodents two hundred seventy primates. One hundred nine fish thirty one lower morphs. An order that includes rabbits and hares. Twenty must That's animals such as ferrets and weasels. Twelve amphibians six cows and five goats.

Food And Drug Administration Commissioner Scott Gottlieb Welfare Council Jane Goodall Gottlieb Taraji Rabins FDA
Gottlieb says vaccines should offer "reasonable protection" against coronavirus variants

Atlanta's Morning News

01:01 min | 6 months ago

Gottlieb says vaccines should offer "reasonable protection" against coronavirus variants

"Cases begin to decline across the country, but a troubling number in Georgia. Double the SPS Bill carpaccio reports live on efforts to get the pandemic under control. Yeah, yeah, The nearly 180 new coronavirus deaths recorded in Georgia on Saturday is a new single day record. Race is on to get more people vaccinated. We have to get those vaccines into many, many more people before we see the decline. CBS NEWS Medical expert Dr David Vegas worries about new strains of significant concern. Over these new variants, former FDA commissioner Scott Gottlieb tells CBS's face the nation. He is encouraged by the vaccines. I do think that the existing vaccines are gonna offer reasonable protection against these new variants. Dr. Walter Orenstein with Emory University's Hospital of Vaccine Center tells Channel two action news People should trust vaccines are safe. Warp speed, which initially sounded like a great name has given people thoughts. Corners have been cut. Despite the variants, he says, the vaccines are more effective than no vaccine it all drug companies are already working on booster shots, which could be available by this fall.

Bill Carpaccio Dr David Vegas Georgia Scott Gottlieb Dr. Walter Orenstein Cbs News Emory University's Hospital Of CBS FDA
Nursing homes should see 'some indication' of vaccines having an effect 'as early as this week,' Gottlieb says

Sean Hannity

00:29 sec | 7 months ago

Nursing homes should see 'some indication' of vaccines having an effect 'as early as this week,' Gottlieb says

"Most people won't get a vaccine for the coronavirus for many months, but former FDA commissioner Scott Gottlieb tell CBS that targeting elderly people in long term care facilities as Florida has done could show benefits much sooner. We will start to see some indication that the vaccines are probably having an effect, maybe as early as this week because we know that immunity does start to kick in. Maybe a week after vaccination, they went into the skilled nursing facilities. First, health experts projected for things to return to normal 70 to 85% of people would need to get it back.

Scott Gottlieb FDA CBS Florida
Gottlieb sees Thanksgiving as "inflection point" for pandemic

Bloomberg Daybreak: Asia

00:52 sec | 9 months ago

Gottlieb sees Thanksgiving as "inflection point" for pandemic

"And the election happens now, with weekend reports of a second surgeon. Large sections of the U. S of covert 19. And the Trump administration, saying the U. S is round the corner in the fight against it. Former FDA commissioner Scott Gottlieb on CBS says not so things are getting worse around the country. I think Thanksgiving is really going to be an inflection point. I think December is probably going to be a toughest month. When you look at what's happening in states right now you're seeing accelerating spread. We're right at the beginning of what looks like exponential growth in a lot of states, the Midwest, the Great Lakes region, and Dr Anthony found she's coming out stronger today, saying that Mr Trump is not listening to infectious disease docks anymore, and that the US is in for a world of hurt. And, in fact a second surge through much of the Midwest, now North East New York ST requirement. The visitors test negative before arrival in quarantine for three days after entry before taking a second test on the fourth day,

Midwest Mr Trump Scott Gottlieb FDA Great Lakes Commissioner Dr Anthony CBS United States
States struggle as coronavirus cases spike

WTOP 24 Hour News

00:53 sec | 1 year ago

States struggle as coronavirus cases spike

"Are worsening pandemic at the height of the summer. Bottom line is cases and deaths spike across the nation southern tier from California to Florida and most of the states in between Arizona a grim milestone state hitting its highest daily death toll Saturday. There, the federal government stepping in to increase testing in hot zones, touches to minimise the risk California also struggling to meet its testing targets. Seen deaths nearly tripled since the state's economy re opened in May. CBS's Lilia Luciano, more than 140,000 people have died of covert 19 in this country. Former Food and Drug Administration Commissioner Scott Gottlieb warns. You have epidemics in Texas and California and Florida and the testing companies a big commercial labs like lab corn Quest. Try to prioritize testing those regions. Not only do they fall behind in those regions, but now they're pulling testing out of other regions in seeing delays. There.

California Florida Lilia Luciano Food And Drug Administration Scott Gottlieb Arizona CBS Commissioner Texas
Gottlieb says U.S. "right back where we were" at earlier virus peak

WBZ Morning News

00:17 sec | 1 year ago

Gottlieb says U.S. "right back where we were" at earlier virus peak

"Former FDA commissioner Scott Gottlieb says. The US is back where it was at the pandemics earlier peak in the spring. The difference now is that we really had one epicenter of spread when New York was going through its hardship. Now we really have four major happy centers of spread, and that is CBS's Tom

Scott Gottlieb FDA Commissioner New York United States CBS TOM
Gottlieb says U.S. "right back where we were" at earlier virus peak

WBZ Morning News

00:41 sec | 1 year ago

Gottlieb says U.S. "right back where we were" at earlier virus peak

"Meantime, as Massachusetts is proving to be one of the states as an example of how to safely contain the spread of the virus. Most parts of the country is a struggle to say the least. Florida, Houston, Texas, Arizona and Los Angeles County. Are the nation's covert hot spots, with cases soaring by the thousands every day. We're not going to really be able to crush this virus at this point, because there's just so much infection around way really don't seem to have the political will to do it. Former FDA commissioner Scott Gottlieb says. The US is back where it was at the pandemics earlier peak in the spring. The difference now. Is that we really had one epicenter of spread when New York was going through its hardship. Now we really have four major happy centers of

Scott Gottlieb Los Angeles County Massachusetts FDA Commissioner United States New York Houston Florida Texas Arizona
More states halt reopenings as COVID-19 cases surge

The Daily 202's Big Idea

10:24 min | 1 year ago

More states halt reopenings as COVID-19 cases surge

"When the first corona virus cases appeared in Chicago back in January they bore the same genetic signatures as a germ that emerged in China weeks before. But HIS EGON Oser an infectious disease specialist at northwestern examined the genetic structure of virus samples from local patients. He noticed something different. A change in the virus was appearing again and again this mutation associated with the outbreaks in Europe and new. York City eventually took over Chicago by May. It was found ninety five percent of all the genomes that he sequenced. At a glance, the mutation seem trivial about thirteen hundred amino acids, service building blocks for a protein on the surface of the virus in the mutant virus, the genetic instructions for just one of those amino acids number six fourteen switched in the new variant from a D. which is shorthand for. Asset to a G, which is short for Lycene. But the location of that mutation was significant because the switch occurred in the part of the genome that codes for the all important spike protein. The spike protein is the protruding structure that gives the corona virus. It's crown like profile, which also gives its name the crown virus, and allows it to enter human cells the way a burglar picks lock. And Its ubiquity at this point is undeniable of the approximately fifty thousand genomes of the virus that researchers worldwide have uploaded into a shared database about seventy percent carry the new mutation, which is officially designated as D, Six fourteen g, but known more familiarly to the scientists on the front lines of this fight by one letter. G. G. Hasn't just dominated the outbreak in Chicago. It has taken over the world and now scientists are racing to figure out what it means. And how to stop it to of Our Star Science Writers Sarah Kaplan Join. Reported at least four lab experiments suggest that this mutation makes the virus significantly more infectious, although none of that work has yet been pure reviewed, another unpublished study led by federal scientists at Los Alamos National Laboratory asserts that patients with the g variant actually have more virus in their bodies, making them more likely to spread it to others. The mutation does not. Does Not appear to make people sicker, but a growing number of scientists worry that it is making the virus more contagious. The scramble to unravel this mutation mystery embodies the challenges of science during the coronavirus pandemic with millions of people infected in thousands dying every day around the world, researchers strike a high stakes balance between getting information out quickly. And making sure that is right. The burglary analogy is when I found very helpful, because it really helps conceptualize what this virus is doing to our bodies, Joel likes to say that the coronavirus can be thought of as an extremely destructive burglar, unable to live or reproduce on its own. It breaks into human cells in coops, biological machinery to make thousands of copies of itself that leaves a trail of damaged tissue and triggers an immune system response that for some people for many people can be fatal, the so-called side kind store. This replication process is messy, even though it has a proofreading mechanism for copying its own genome, the coronavirus frequently makes mistakes. Those are the mutations. The vast majority of mutations have no effect at all on the behavior of the virus. But? Few genetic mutations could be more significant than the ones that affect the spike protein. That is the viruses lock pick the most powerful tool against us. The protein attached to a receptor on respiratory cells, called as to which opens the cell and let's the virus slip inside. The more effective despite protein, the more easily the virus can break into the bodies of its hosts, even when the original variant of the virus emerged in Wuhan China. It was obvious that the spike protein was already quite effective. But, it could have been even better. The spike protein for the coronavirus has two parts that don't always hold together well when you look at it under a microscope in the version of the virus that rose in China the outer part, which the virus needs to attach to a human receptor, frequently broke off equipped with this faulty lock pick. The virus had a harder time invading Ho cells. Studying both variations of the gene, using a proxy virus, in a Petri dish of human cells heireann show a virologist at scripts. Research found that viruses with the g variant had more spike proteins in the outer parts of those proteins were less likely to break off. In that research. The virus was ten times more infectious with that mutation. The good news is this. The mutation does not seem to lead to worse outcomes for patients, nor does it alter the viruses response to antibodies from patients who had the D variant? Suggesting again? This is great news that vaccines being developed based on the original version of the virus will be effective against the war infectious European strain. Identifying, emerging mutations allows researchers to track their spread, knowing what genes affect how the virus transmits enables public health officials to tailor their efforts to contain it wants therapeutics vaccines are distributed on a large scale. Having a baseline understanding of the genome will help pinpoint when drug-resistance inevitably starts to evolve. None of this unfortunately is a magic bullet, but experts say that understanding how the virus works will help respond better. Still, it's a race against time. And Right now. The virus is winning. And, that's the big idea. Here are three other headlines that should be on your radar. This Tuesday number one. US deaths are approaching one, hundred, twenty, five thousand. We expect to pass that number today and the total number of confirmed cases, here's top two and a half million amid worsening outbreaks in Florida, Texas and Arizona that are straining hospital capacity to the Limit Jacksonville, the largest city in Florida and the host to the Republican National Convention in late. August announced that masks will now be mandatory in public and indoor locations. Vice President Pence plans to go ahead with plan travel this week to Florida and Arizona, even though cases are spiking, but Arizona Saul another record, high and hospitalizations days after trump visited the state for a raucous indoor rally where almost no one more mask. Florida's Rolling Seven Day. Average has risen by one hundred percent since week ago. Trump's former FDA commissioner Scott gottlieb warned last night. Night that the surging number of cases could result in nearly half our country infected with the virus by the end of the year and overall deaths are likely to return to more than one thousand per day. He predicts in fact, the number two at the CDC, told the Journal of the American Medical Association yesterday that the US. has quote way too much virus to be. Be Able to contain it anymore and shoe cat said that we're no longer in a position like New Zealand or Singapore. South Korea, where new case can be rapidly identified, and all the context traced and people are isolated or sick and people who are exposed or quarantined, and that's how you keep things under control. She said instead. We have way too much virus across the country. Country for that right now. She described herself as very discouraged and added. This is really the beginning I think there was a lot of wishful thinking around the country that hey, it's summer. Everything's GonNa be fine, but she added that she seemed quote a lot of worrisome factors over the last week or so and added quote. We are not even beginning to be over this. And, we're seeing that on the front lines. Los Angeles County health officials have issued a dire warning in the last twelve hours that conditions are rapidly deteriorating in the nation's most populous county as the virus spreads quickly, officials are warning that both public and private hospitals in the city of angels may soon be overwhelmed leading to triage. One factor that's alarming leaders in southern California. Is that corona virus patients are crossing the US Mexico border to seek medical care. Now, a lot of Americans seeking treatment. But the head of California's Emergency Medical Services Authority describes the stream of patients crossing the border back and forth as quote pouring gasoline on the fire. Arizona Governor Doug Ducey pushed back his plans to reopen public schools and has banned gatherings of more than fifty people. He also has closed down bars, nightclubs, movie, theaters and water parks. All of which he recently reopened as we discussed last week warning residents that we can no longer be under any illusion that the viruses going away on its own other hard hit states, including Tennessee and Georgia have put in place new stay at home. Orders extended them. There are so many unsettling stories just popping up across the country that it's hard to keep up more than two hundred people in West. Virginia were advised yesterday to quarantine after possibly being exposed to the virus will working out at a gym. New Jersey. Governor Phil Murphy says plans to allow indoor dining or are going to be postponed indefinitely while New York Governor Andrew, Cuomo says his administration is reconsidering whether indoor dining can restart safely. New York City next week, which was going to happen as part of its phase three now this is a big blow for restaurant owners in the tristate region who've been preparing to reopen by hiring staff that they'd laid off and restocking their inventory as they teeter on the precipice of bankruptcy, a lot of that food may now need to be thrown away and Broadway's main theaters all said yesterday that they're going to remain shuttered until at least January and probably longer.

Arizona Chicago Florida China United States California Europe Egon Oser Lycene New York City York City New Jersey Los Alamos National Laboratory Virginia Burglary Sarah Kaplan Doug Ducey Wuhan China New Zealand Los Angeles County
FDA approves new coronavirus antigen test with rapid results

Bloomberg Daybreak: Asia

00:21 sec | 1 year ago

FDA approves new coronavirus antigen test with rapid results

"Late Friday here in the states a new antigen tests to rapidly screen for the corona virus was given emergency use authorization by the FDA this is an approved test now from quite dealt it relies on specimens taken from nasal swabs former FDA commissioner Scott Gottlieb saying today this is a game

FDA Scott Gottlieb Commissioner
San Francisco officials look to ban sale of e-cigarettes

CNBC's Fast Money

01:27 min | 2 years ago

San Francisco officials look to ban sale of e-cigarettes

"Shares of Altree dropping today. After officials in San Francisco announced they will seek a ban on the sale of e cigarettes in the city. Let's get to a D ROY in San Francisco with more on this developing story Haiti. Hi there Melissa San Francisco city attorney city supervisor say the FDA has not done enough to curb e cigarette use among kids. So they wanna crackdown on those products in the city. They just introduced a Bill which would prohibit the sale of e cigarettes in San Francisco and also prevent e cigarette companies like jewel from occupying city owned property in the future jewel is currently headquartered in San Francisco on city owned property, but the company would be grandfathered in should the city approved the Bill, however, if the measure passes, it would prevent jewel from expanding its footprint on city owned property. In a statement Joel says we encourage the city of San Francisco to severely restrict youth access, but do so in a way that preserves the opportunity to eliminate combustible cigarettes in another development in the space outgoing FDA Commissioner Scott Gottlieb said today at a Brookings event. Then he met with jewel and Altria, which of course, owns thirty five percent of jewel, and he called the meeting quote difficult jewel had no. Comment on the meeting other than acknowledging it took place last Wednesday in response to Gottlieb's comments one analyst from consumer edge says while Altria has levers to pull to manage earnings in the short term, the regulatory risk in the US is about long term free cash flow, which is reflected in tobacco discount

San Francisco Melissa San Francisco Commissioner Scott Gottlieb FDA Altria Altree Haiti D Roy United States Analyst Joel Supervisor Attorney Thirty Five Percent
Flavored vapes draw FDA ire, with some exceptions

Morning Edition

01:26 min | 2 years ago

Flavored vapes draw FDA ire, with some exceptions

"The FDA is turning up the pressure on e cigarette makers it's issued proposed rules yesterday that would further restrict sales of certain flavored e cigarettes the rules wouldn't apply to mint or menthol flavors. Marketplace's Nancy Marshall genzer has more on the rules. And what they would mean for e cigarette makers and sellers. It's already illegal to sell e cigarettes to anyone under eighteen. The proposed rule tackles cigarettes with flavours that appeal to kids like cotton candy. There would be stricter age verifications for online sales and convenience stores would have to build a separate room for these flavored e cigarettes, according to Spencer, Perlman fada partners, essentially, any retail location would have to have a physical barrier that would prevent anybody under the age of eighteen for entering the space where these flavored e cigarettes are being sold. The national association of convenience stores says it's considering a lawsuit against the FDA, but it may not need to sue FDA. Commissioners, Scott Gottlieb said on CNBC today that his agency may just outlaw these flavored e cigarettes at some point they youth use of those products become so intolerable that they have no redeeming public health valley, and we'll just have to sweep the market of those products. And that includes jewel Gottlieb says last year vaping by highschoolers shot up. Seventy eight percent Gottlieb is leaving the FDA sometime in the next month. But he says his plan has the full backing of the

FDA Jewel Gottlieb Scott Gottlieb Nancy Marshall Genzer Cnbc Spencer Perlman National Association Seventy Eight Percent
FDA Commissioner abruptly resigns to spend more time with family

Business Beware

00:18 sec | 2 years ago

FDA Commissioner abruptly resigns to spend more time with family

"Visited interpreters prison. FDA Commissioner Scott Gottlieb who surprised a lot of people by turn on his resignation. And he says he wants to spend more time with his family. He wrote the intensity for over two years. Tackling opioid abuse drug charges and teenage footing pecan after about a month.

Commissioner Scott Gottlieb Opioid Abuse FDA Two Years
Commissioner Scott Gottlieb, FDA And Two Years discussed on Howie Carr

Howie Carr

00:12 sec | 2 years ago

Commissioner Scott Gottlieb, FDA And Two Years discussed on Howie Carr

"Or today. FDA Commissioner Scott Gottlieb stepping down during his nearly two years at the FDA he oversaw the agency's response to the opioid epidemic rising drug prices and

Commissioner Scott Gottlieb FDA Two Years
Are Nutritional Supplements a Waste of Money?

The Nutrition Diva's Quick and Dirty Tips for Eating Well and Feeling Fabulous

02:29 min | 2 years ago

Are Nutritional Supplements a Waste of Money?

"Of the multibillion dollar supplement industry. Now that would include everything from the calcium and multivitamins at your local drugstore to those questionable weight loss and virility supplements that you see pitched on late night cable TV stations, according to the FDA three out of every four Americans takes a dietary supplement on a regular basis and for older Americans that rises to four out of five. Meanwhile, one in three of our kids are taking supplements. Now, all of these are currently regulated under guidelines known as dish that stands for dietary supplement, health and education act. According to these regulations manufacturers are responsible for ensuring that their products are safe and correctly labeled. However, unlike drugmakers supplement manufacturers do not have disappeared. Proof of safety or efficacy before bringing their product to market it sort of an honor system, if you get caught doing something wrong, you'll be punished but for the most part and without evidence to the contrary. There's an assumption that people are following the rules in the twenty five years since these regulations were enacted the supplement industry has grown tenfold from about four thousand products back in nineteen ninety four to over fifty thousand different products. Now with this explosive growth has come an increasing number of what FDA Commissioner Scott Gottlieb, calls bad actors companies that are either intentionally or maybe even accident-free breaking the rules as a result. There's a greater chance that consumers will be exposed to products that have undeclared or even illegal ingredients or contaminants, and there's also a greater chance. That products may include unapproved or inaccurate health claims. In response to all of this Gottlieb intends to step up enforcement of the regulations. And hopefully, this will result in fewer people going to the hospital emergency room due to adverse effects from dietary supplements in twenty fifteen for example, there were twenty three thousand such visits. But to tell you the truth, even when manufacturers are strictly obeying the rules. They're still a lot of potential for consumers to be wasting their money on supplements that simply aren't doing anything for them before he continue. Let me take a quick break to thank our sponsors.

Commissioner Scott Gottlieb FDA Twenty Five Years
FDA takes actions against 17 companies selling products illegally claiming to treat Alzheimer's

WBZ Afternoon News

00:45 sec | 2 years ago

FDA takes actions against 17 companies selling products illegally claiming to treat Alzheimer's

"York, the food and Drug administration threatening legal action against the makers of fifty eight products for making false claims about fighting Alzheimer's. The FDA saying the products mostly dietary supplements like fish oil vitamin C, FDA Commissioner Scott Gottlieb, says the FDA making sure supplements don't fall in the regulatory cracks between food and medicine creating a comprehensive team within the data center work in a more cohesive fashion to make it more efficient for us to bring targeted enforcement actions against. Drug ingredients and Gottlieb says the warnings come as the agency refines its enforcement procedures says the agency will start notifying the public ahead of enforcement actions when it spots products making questionable

Food And Drug Administration Commissioner Scott Gottlieb Alzheimer York
FDA to resume inspections of riskiest foods amid shutdown

24 Hour News

00:43 sec | 2 years ago

FDA to resume inspections of riskiest foods amid shutdown

"Many food safety inspections carried out by the food and Drug administration have been halted because of the government shutdown, but as AP's Jackie Quinn reports inspections of some of the riskiest food products will resume as early as Tuesday. There had been a brief interruption in the inspections of food items like produce cheese and infant formula considered riskier than packaged foods. And now FDA Commissioner Scott Gottlieb says they're bringing back about one hundred fifty employees to check those foods employees who will be unpaid. The agency says it's inspections of imported foods and the monitoring for contamination have not been interrupted. Neither were the meat poultry and egg inspections which are done by the agriculture

Food And Drug Administration Commissioner Scott Gottlieb Jackie Quinn
FDA to resume inspections of riskiest foods amid shutdown

News and Perspective with Tom Hutyler

00:29 sec | 2 years ago

FDA to resume inspections of riskiest foods amid shutdown

"Day and the FDA says it will resume some food inspections. Details from ABC's Mark Remillard FDA. Commissioners, Scott Gottlieb says the agency will resume inspections of some of the riskiest foods, including cheese produce an infant formula as early as today. Routine inspections had been briefly halted as a result of the shutdown. But now Gottlieb says the agency is bringing back about one hundred and fifty unpaid workers to conduct inspections meat, poultry, and processed eggs are checked by the department of agriculture and have continued during the

Scott Gottlieb FDA Mark Remillard ABC Department Of Agriculture
FDA to resume inspections of riskiest foods amid shutdown

KDWN Programming

00:40 sec | 2 years ago

FDA to resume inspections of riskiest foods amid shutdown

"The government reopened to see the cheques. Meanwhile, the food and Drug administration says it's resuming inspections of some of the riskiest foods, you're talking cheese produce infant formula as early as today routine inspections had been briefly halted as a result of the partial government shutdown FDA Commissioner Scott Gottlieb said the agency's bringing back about one hundred fifty employees for inspections a riskier foods account for about a third of the agencies roughly eighty four hundred routine inspections each year, Los Angeles unified school district schools are open that despite a strike by the teachers union. Thousands of educators in the nation's second largest school district

Food And Drug Administration Commissioner Scott Gottlieb Los Angeles Teachers Union
"commissioner scott gottlieb" Discussed on The Skeptics' Guide to the Universe

The Skeptics' Guide to the Universe

03:11 min | 2 years ago

"commissioner scott gottlieb" Discussed on The Skeptics' Guide to the Universe

"Our EMS to via should only be administered by healthcare provider in a certified medically supervised healthcare setting that really encompasses this this conversation. There was a big press release from the FDA Commissioner Scott Gottlieb that came out on November second when to via was officially approved. You can read it in full. It's very long statement trying to answer a lot of the concerns that people have voiced since this drug became marketable. And since people started to realize that this was probably going to potentially become approved by the FDA. So. So so here are the big concerns. We already have su- fennel on the market is of course, though, already available only through intravenous administration. So the argument here is that there are situations in with in which a patient might need immediate reduction of acute pain through something very very strong. And when I say, strong, how are they usually wording. These articles Sufen channel is ten times more powerful than Fenton hill. And it is I think what is it a thousand times? Or is it one hundred times? Steve do you remember more thousand thousand times? Yeah. More potent is the best better. That's a little more accurate at times more potent than morphine ten times more potent than fentanyl. No that doesn't mean necessarily that. If you take the same amount, you'll be a thousand times more like eft up. What it really means is that it takes much much less of the drug to have the same effect. So obviously, the potential for abuse of something like this is potentially enormous if it's not well, regulated so popular sites gives a little bit of background on the opioid quote unquote epidemic from one thousand nine hundred nine to twenty sixteen over six hundred thirty thousand people in the US have died from drug overdose and over half of those so more than three hundred fifteen thousand of those within that time span directly involved opioid medication. That's according to the CDC on average when calculated about one hundred fifteen Americans die every day for an opioid over. Us. So keep that in mind now, many of these people have prescription opioid drugs available to them many of these people are using opiates that they've purchased on the street. Bentonville can be abused on the street. And it is actively like there are many cases of people overdosing onto feno. This new drug again called the Suva, which is sub lingual form of Sufen fennel is a single tablet and the way that that tablet is administered is through a single use package. So it looks like it almost looks like a little needle. But instead of a needle a push administrating piece of classic that pops the little tablet underneath a person's tongue and the entire package is only loaded with one tablet, and so the idea here is that that should reduce the ability for abuse because you're not buying a bottle of pills at a time. You get a single dose in your administration, and we're not talking prescription that you.

FDA Commissioner Scott Gottlieb drug overdose acute pain US Suva Fenton hill Sufen morphine fentanyl Bentonville Steve CDC
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:30 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"I've heard asked of your female colleagues how do you balance being a working dad with the job of being FDA Commissioner, it's very hard. I'm away from my family during the weekend. It's very hard so hard as part of the job is is the fact that I'm away from my family, and even when I'm home on weekends. You know, I spent one whole day working. So I don't think I'm balancing very, well, did you balance it better in some way? Given the demands of this job. It's hard these twenty four seven jobs, and I think I think, unfortunately, that's the only way to do these jobs. Well, there's going to be a new planned community next door to FDA. I saw you with the groundbreaking. I watch video of you with Maryland governor, Larry HOGAN, could you buy a home in that next community that community will be fully erected? I think in sometime like twenty twenty five. So I'm not making long-term plans out that far. Last question when I sat down with CMS administrator Andy Slavic at the time in two thousand sixteen I think it was the first episode of this podcast. He made a comment like I need to do something on drug pricing. If I don't the next guy who comes in the next person who comes in. We'll say what the heck was slab thinking, what is the thing that you need to accomplish that if the next FDA Commissioner comes in and it hasn't been done. You will feel like the work was unfinished. Well, look, I feel good about what we're doing our job in the pro drug pricing debate is to try to bring more product competition to the market. I feel like we're doing that successfully. In terms of the reforms will make making the generic drug side. I think there is there is not as much recognition as the obstacles that branded companies face bringing follow on innovation to the market and some of these these drugs targeting on medical needs. We you see companies maintaining monopolies for longer periods of time and sometimes in perpetuity for drugs targeting unmet, medical needs, and that lack of competition against branded drugs is maintaining higher prices for long appear. As of time we have data demonstrating this. Now, I'm gonna be publishing a study that we did our own analysis showing that when we look at a cohort or drugs from the early two thousands to the current cohort of drugs over five or ten year period is taking much longer to get the second and third to market drug to the market now than it did ten years ago, and there's reasons for that. And I think there's things we can do to address it. But if that if that trend continues, and if you see venture capitalists and companies pulling out of the market, if they don't think that they can be first to market we're going to have significant challenges going forward, keeping these drugs affordable. The other thing that I'm going to be focused on in two thousand nineteen is looking at ways to try to improve the overall economics of generic drug development. I think that that industry is facing some pressures a lot of more commercial pressures that we can't affect. But I think some of them are regulatory. I think the multiple cycles of review are very costly to the industry. I think there's things we can do to make it less expensive and more efficient to file generic applications and get more generic companies into the space. See more competition, and we're going to be very focused on some of those reforms also making high value opportunities available to share companies that means you know, what we can do in biosimilars what we can do on drugs that have Rhames associated with them. What we can do in hard to formulate drugs to make it easier to genera size those drugs. Well, that's a lot of stuff to finish. No wonder you're working sixty's a week. Really could be working seven. But we will let you get back to your work. Commissioner Scott Gottlieb. Thank you for joining politico. Bolster thanks for having me. That's it for pulse. Check this week. My thanks to Commissioner, Scott Gottlieb and his team for making time and space for this interview. And my colleagues are over mall for making her long way to debut on politico. Pulse. Check as always

Commissioner FDA politico Scott Gottlieb Andy Slavic Maryland Larry HOGAN administrator biosimilars ten years ten year
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:41 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"It's been about four months since secretaries are recommended that you form a working group on drug importation industry groups have been resistant to this idea. Some Republicans have been critical like Orrin Hatch. Also seems like HHS hasn't been especially enthusiastic about this idea. Is that wrong? Well, I don't I'm not tracking all the criticism. You probably have a better handle on that in terms of what you hearing. Then then may we are we are moving forward with trying to look at a framework on how he would do this. Remember, this this applies to off patent off exclusivity drugs that are in that are so source drugs where they don't face competition where you have a price increase that creates an access dislocation that that forestalls access for certain patients. So we are looking for Justice summarize what you just said it's a very narrow. It's an it's a narrow. It's a narrow set of circumstances where? You have a drug that's off patent where there's something that happens in the market with respect to the price that makes it harder for patients who need the drug to get access to it. So there was a there is a bottom line public health concern in the setting of where we would employ this, and we are actively working through what that framework, look like how we would do it how we would make the legal certification to operationalize it on how we would apply a rationale to look at the drugs that we would seek to import in a very closed fashion. So we can ensure end to end the end to end integrity of the drug as it comes into the United States. This would not be free for all importation. This would be a closed system would be working with an intermediary to import the drug to make sure that we can secure the supply chain as the drug moves from a foreign market here. But look at the same time that I've done this. I've also put forward policies to try to create a global globally harmonized approval process for generic drugs to make it easier for generic drug companies to file what will hopefully eventually be a global applications. So if you're a European if you're a small European generic manufacturer, and you're manufacturing in in France, we wanna make it easy for you to follow the same application to US and bring that drug into the US market that I think will be hopefully in the long run a bigger opportunity to get more competition into this market than trying to do, you know, one off import Titian when these situations arise I want to prevent the situations where we have these sort of sole source drugs where you can have a speculator come in and take a big price increase and try to play. What I say what I call regulatory arbitrage hoping that they can sustain the price in the market long enough to return a profit before we can approve the next generic drug and bring in competition. So understanding that those are goals. I still don't think that there's been a lot of public information here, can you share who the members of the working group are for instance, who are working with the leadership of HHS. And you know, we're pretty far along. I think that we're we're pretty far along in mapping out. What the what the framework would look like, I can't give you a timeframe in terms of when we would, you know? Bounce a final framework when we might seek to import drug, but in terms of working through the the mechanics of how this would work what the legal issues are we've been spending a lot of time on this. You know, it seems like a long time to you from the date that we initially announced this two now, and I forget when we announced bobbly three or four months ago, but in July nineteen July, but in terms of government on top of your head. The. Terms of government policy making working through, you know, difficult issues. That's not a time. You know, these things do take time to put in place, and as a reason why they should take time because we're changing policy, and we want to be delivered about it. We need to be careful. I mean FDA is a is a complex agency with a complex statute. And there's a lot of implications..

Orrin Hatch United States HHS FDA France four months
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:51 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"To choose not to vaccinate the kids on rationale that doesn't comport with science doesn't doesn't isn't directly related to health concerns. Those are all deeply concerning to me, and you know, out continue to be outspoken, and and trying to promote higher vaccination rates and trying to continue to support, you know, the safety of vaccines and regulatory process that overseas at one of, you know, one of the things that I think I can do to try to affect this debate is just to reassure people that we are aggressive in continuing to look at the safety net. See vaccines, and when we we learned something we make it known publicly, no products completely safe. There are side effects associated with vaccines. They're very rare. But there there are side effects. We need to speak honestly about that. Since we're talking about the president. I wanna talk about some of his other priorities that bring in your agency fighting the opioid crisis and this month. You teased a new approach to proving some opioid medications. Can you be more specific about the timeframe and the details of what that approach will declare? We're going to announce a public meeting very soon where where it's going to be sort of the first step towards trying to develop that framework and gather public input on what that would look like. And you know, this is a regulatory process takes time to unfold, you would have we we're gonna start it with a part fifteen hearing and put out a series of questions and open a dock and try to gather information. But the essence of it is that you know, we we've had criticism around the approval of selected opioids, and you've covered some of those criticisms, I think that underlying those criticisms isn't a question of whether this drug should have been approved of that drugs should have been approved. I think that what underlies those concerns our concerns from people who say in the throes of an opioid epidemic a massive opiates epidemic. Why do we need yet? Another opioid drug and is this drug going to be differentiated in some way that is going to provide additional public health benefits on top of all the available therapy. Or is it just another drug that could lead to addiction and abuse and misuse now setting that said supply doesn't create demand simply having more opioid drugs on the market isn't going to create more addiction. But if you have more opioid drugs on the market that have that a more likable or have more potential for abuse misuse that could drive more more addiction. But I think we have an obligation from public health standpoint to tackle the underlying question of should we have more opioid drugs. And if so what should the standard be and what I've proposed is asking the question of whether or not we should have a public health standard around the approval of new opioids where when we approve an opioid. We're looking at it against the overall therapeutic or Metareum and asking the question whether or not is differentiated providing some additional benefit over the existing drugs or whether or not it has a risk of. Being misused or abused a diverted because of the features that drug but looking at it in the context, not just that individual approval, which is generally how we look at drugs. Now, we look at an opioid drug against itself. But looking at it against all the other drugs within the category, and whether or not it's going to have a role in the overall therapeutic approach to the treatment of pain. That's a much different approach. That's a different standard Fowley would look at this. But I think congress has told us they want us to be thinking about opioid approval and controlled substances in a different way, the controlled substances act is the clearest expression from congress that they want. They want agencies to be thinking about the approval of these products differently. And we've got formation of that in a recently enacted opioid legislation with congress gave us a very specific set of authorities on how they want us thinking about opioid drug approvals that don't apply to any other therapy class. So I think we have an obligation to try to tackle this question. Head on. I don't wanna be having these debates in the context of this approval and that approval and people criticizing the individual drug approvals. What I wanna do is. Have an open honest debate about what I think is the underlying question is why another opioid drug in a setting of an addiction crisis shifting from opioids to drug pricing..

congress president Fowley
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:51 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"There have been studies on teen pregnancy prevention that have been canceled. There's an agency wide review on fetal tissue research. And I've talked to officials political appointees career staffers who've said there's a there's a war at times between being pro-life and being pro science. Do you share those concerns, and if not do you understand why staff would have them? Well, I think with respect to the FBI look at the FDA, and I'm not I'm not following all the headlines that you are on all these other issues. I think with. Respect to the FDA. We've been very consistent and adherence to good science based decision making. I think my interactions with people in his administration have demonstrated not only an appreciation for the importance of that principle, but in a preoccupation for the unique mission of FDA. And I think impart why I've, you know, believed that I've been able to advance a robust policy agenda cross a lot of different areas that I believe is public health minded, advancing, you know, initiatives and programs that are gonna have a public health impact. Like what we've done on tobacco. Like what we've been able to do with respect to some of the changes made terms of how we regulate opioid drugs is because there's people in key positions of this administration, including secretaries are whoever deep understanding of FDA deep respect for its mission a deep respect for the science based decision making at the agency. And the secretary has been exceedingly supportive of the agency an exceedingly supportive of my Bill. To make independent decisions, you know, working with the professionals at at the FDA, and is one of the things I think I talked about the last time we spoke and one of the lessons. I learned when I work with Mark McClellan Moi's that it's very important that the the decision making and the ideas come out of the career staff FDA is not an agency where you can engage in top down policymaking where I can sit in my office with a Kabbalah people writing guidances and policy documents and try to impose it on on the, you know, the workings of the agency my job is to set out, you know, broad goals parameters public health goals that we're I think we should be investing our time try to get those resource, but the ideas in terms of how we're going to achieve them half to come from the professional staff, and it's my my job to work to make sure they get implemented. There was a recent survey by the union of concerned scientists that under the Trump administration many government science. Tests have been unhappy at places like EPA that is not the case FDA if anything happiness has been up under under your leadership one concern that some scientists have brought up to me is what the president has said at times about vaccines. You've been an unflagging champion Commissioner of the value vaccines. President Trump at times as questioned the Rafic ac- before being elected after being elected floated the idea of of vaccine safety commission. Have you ever spoken with the president about vaccines? I have not what would you tell him while I continue to speak privately about the things. I speak publicly. I don't think that my advice, privately is private and private is any different than my advice in public. I, you know, support support the role of vaccines. I think it's one of the greatest public health achievements of of humankind. Our ability to develop vaccines for vexing infectious diseases. I think that the, you know, the high vaccination rates that we've been able to achieve historically against pediatric diseases in particular have been one of the profound chievements of of modern. Medicine and to see those those gains reversed by fears that I don't think grounded in science and am talking particularly about some of the criticism around the MR vaccine would receive vaccination rates declining. And we see local communities putting in place ordinances allow people.

FDA president President Trump FBI Trump Mark McClellan Moi secretary Commissioner EPA
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

01:30 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Wanted to help promote this opportunity for adult currently addicted adult smokers, but we said then, and we said all along that it cannot come at the expense of addicting a whole generation of young people on nicotine threes cigarettes. And that's exactly what's happening. We warned the companies we told them that we wouldn't tolerate it. And we're not going to be tolerating. You mentioned the moves that your agency has made last year FDA decided to push the deadline for regulatory review of the e cigarette products to August twenty twenty two almost four years from now. So putting that in plano. English e cigarettes can hit the market without approval from FDA. Why did you make that decision? And or you re thinking that while it was e cigarettes that were on the market as of two thousand sixteen can continue to stay on the market until that date, if I hadn't changed that date, the applications would have been do about a month ago or two months ago, and there's the potential that these products would have had to come off the market a year from now. I still think we are trying to strike the right balance between trying to more rapidly migrate adult smokers off of combustible tobacco by regulating the nicotine levels in in combustible cigarettes to minimally a non indicative levels while still providing an opportunity for adults who want to get access to satisfy levels of nicotine to do through products that are less harmful. That means nicotine replacement therapy. The least harmful form of nicotine delivery, things like, you know, gums and patches that you might be able by a pharmacy without a prescription. And we've put out new policy to try to promote development of those products. But it also could mean things likely attrac- nicotine.

nicotine FDA plano four years two months
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

03:05 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Make it easier to achieve dual oversight dual jurisdiction. We'll call. Cultured meat now. So lexicon has changed. But I think that I've been working very closely with USDA meeting with meeting with the deputy secretary the secretary we've had other discussions. I think we are very close to having a proposal on how the two agencies are going to work together, very closely insured jurisdiction here in a way that makes policy sense. And in a way, that's gonna make scientific sense in terms of the different processes involved in developing these products, and which agency has expertise in different areas of how these products are developed. So I feel very good that we're on. We're in the final stages of having a joint framework to agencies can work on together. And my hope is that if if we go out publicly, you know, with some some robust proposal on how we're going to approach this going forward that congress would give deference to the agencies to work out the fine print on how we would implement that. And if it requires legislation down the road to fully codify that if congress wants to come. In god. If I what we do, obviously. I'd welcome the input from congress. But I would hope that congress would give us the opportunity to work out these details. This is very new science. It's it's complex, and I think it's best work through by the agencies, and then we can be in a better position to inform congress if they want to legislate here. So I just to translate because they didn't hear yes, or no, you think congress, regardless of who controls what chamber should be deferential to the agency on something of this matter. Well, I think this is I think this is a very new area of technology. We're often in a position of having to to figure out how to regulate an industry after the fact the industry get started products route in commerce, and then we come in and try to regulate it after the fact this is an an example of where we're trying to lay out the regulatory parameters in advance of these products actually being available. So I think we have time to work this out what I'm saying is I think I'm going to be in a much better position to to inform congress on what I think a proper framework should look like and be an agreement with the secretary Bagley. Culture, go forward with a joint proposal to congress that then they can come in and make a judgment whether or not they agree with us. They wanted they want to legislate in a slightly different way. I think right now anyone who acts including congress on trying to legislate around. This is going to be acting in the absence of of a fuller understanding of what this process looks like because we're still developing it, you know, and if we if we the sort of experts in this will working through these issues are still trying to come up with what their framework looks like I think we have a better better opportunity to inform congress, you know, six months from now three months from now than we do do today. Attorney general Jeff Sessions has departed the Trump administration HHS secretary, Alex as our has been rumored as a possible replacement. I should say that his office has denied that he is interested. But you never know if secretary as ours tapped to be attorney general would you want to be secretary? Well, I'm not going to engage in hypotheticals on hypotheticals other than to tell you what..

congress secretary deputy secretary USDA Jeff Sessions Alex Attorney HHS Trump administration Bagley three months six months
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

04:01 min | 2 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Caller longtime listener, we're glad to have you. And now you'll hear my conversation with Commissioner godly by sat down with him for about an hour at each headquarters in Washington DC on Thursday, you'll hear we get to cigarettes pretty quickly in our talk. But also hit on topics like his leadership of FTA how he thinks about balancing science and politics in this administration opioid policies that he is leading and much much more. Remember to use the show notes to find time cues to locate parts of the conversation, and now here's Commissioner golly. In one of your last interviews with politico at our pro summit, you made the comment that quote, an almond doesn't lactate. This was part of your broader push to move away from terms like almond, milk, and soy milk. You made that point before. But it really blew up. Now that comment is a t shirt late night hosts mocked the idea and ran clips, by the way, the first person to seamlessly work the phrase and almond doesn't lactate into their wedding, vows and. Sends me a video gets. I don't know what t shirts. Were you surprised by that reaction? I was surprised by the reaction you go on Tomasson dot com, and you type in that phrase, and there's a lot of a lot of paraphernalia sold with with the phrasing dozen lactate, including mugs and t shirts. I'm glad that. I I've started a small business industry and help grow the economy with that phrase. But yeah, it caught me by surprise. There is a serious question though, here dairy farmers want to move away from terms like, cashew cheese, or soy milk FDA's trying to thread, the needle, well, you know, there is a regulatory obligation. If they see has with respect to our standards of identity, we have standards of identity that do articulate what food needs to constitute in order to be to have a certain phrases associated with it. So for example, what are you? What does it mean to be up how much tomatoes genie to have in order to have ketchup, and how many tomatoes do you need? I don't know. But, but you know, these these standards of identity have public health importance because people. Due impute certain nutritional content based on the nomenclature being used to describe a food product. And if a food products being described with the nomenclature, what people think they're getting a nutritional content that they're not that could have an adverse health impact. So in the case of milk. We know milk is fortified with calcium and vitamin d and has other nutritional value. If something is calling itself milk, and doesn't doesn't have those nutritional derivatives someone could substitute and their diet, not beginning that nutritional content and suffer adverse consequences than in fact, we've seen cases in the medical literature where parents, for example, that fed their children rice milk. There was some there was some public health implications of that some clinical equality, so one of the things we're asking is whether or not the use of the term milk needs to be be correlated with a certain nutritional value. So, you know, manufacturer might be able to meet those standards, for example, by fortifying the product there's going to be constitutional issues on whether or not we couldn't. Forbid a nut manufacturer from calling on beverage almond milk. Because if you look at the dictionary, the first term of milk relates to electing animal, the second term of of milk is something derived from a nut. So there is a speech issue here that said if we have data demonstrating that consumers think they're getting a nutritional value than a not by the use of the term milk. That's someplace where we might choose to enforce the existing standard of identity differently. And that's the kind of data. We're looking for. That's the process we're going to be going through in terms of evaluating whether or not we should change the way we enforce that existing Senate of identity your agency has been working with the department of agriculture on oversight of lab. Beast me lab lab grown meat. There's been somewhat of a public turf or here. Republicans wanted to give all the authority essentially to US DA. Yes, or no does the house flipping democrat..

Commissioner politico Washington dairy farmers Senate FDA department of agriculture milk
"commissioner scott gottlieb" Discussed on Newsradio 700 WLW

Newsradio 700 WLW

02:35 min | 3 years ago

"commissioner scott gottlieb" Discussed on Newsradio 700 WLW

"Check in kiosks, baggage drop counters and security checkpoints the goal is to replace passports and tickets it's going to be optional for now. But to use it you would enter your passport information when you checked in online. Then apparently at each transition point you approach the kiosk with the cameras. They scan your face and you wait for a green check, Mark. And then you can move on. I don't know. I think it's fast. I just a beep pass to be honest to Stanford until it recognizes. I don't know. We'll say they say, it doesn't have an impact. But of the guy grows a beard. It's got to. I would think it was longer beard. To the face. I would think about hard time. But they say it does not suppose somebody has a face. It's a lot like yours. Yeah. Identical twins. What about that something like that? All right. Yeah. We'll see how that works. Elsewhere the smartwatch. At least in this country is going to come with an EKG an electrocardiogram feature. Yep. Apple's latest smartwatch. But it's only here in the US because the US FDA is the only one that's cleared the function and other countries their regulatory agencies haven't done it yet. Apple so they're not even promoting the feature on their international websites here. If you buy the watch now, you will see it enabled later this year and FDA Commissioner, Scott Gottlieb has said in an interview that he really wants to make it easier for other companies to follow Apple's lead and integrate products like the heart monitor into new consumer gadgets, very friendly to this. Yeah. All right somewhere in the world. The price of gold is attached to the price of beer. It is equated with the price of beer. Yes. The October fest German October fest starts tomorrow in Munich. I think you've got something going we start tonight here in October, veterans and anatomy, right? Well. Well this year after an almost ten percent slump in the price of gold and an increase in beer prices. This Liechtenstein based asset management firm has been doing this relationship since nineteen fifty they say an ounce of gold at the October fest will only get you about ninety three leakers or twenty four and a half gallons of beer nut is the lowest since two thousand nine my Lord. What's the world coming to don't know? But gold prices are down prices are up as our gold prices down. Also compared to traditionally too like silver. Yes, see, they're they're onto something. They are futures. Look like what please. Just a little flat here on the SNP up less than a point NASDAQ up about seven points from the Bloomberg newsroom. I'm Patrice Sikora on NewsRadio seven hundred wwl W..

Apple FDA Scott Gottlieb US Patrice Sikora Mark Munich Bloomberg Commissioner ten percent
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

01:52 min | 3 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Also balance that public health approach with which consumer advocates would really like to see happen so interesting things to watch in general they have to really implement and roll out a lot of food safety regulation that's kind of a legacy of the food safety modernization act so how they do that with limited resources in terms of educating farmers educating manufacturers importers to really get everyone focused on prevention will be interesting so he has a lot of work to do in 2018 it's possible congress i know on the drug cited may eventually add more stuff to their played there's been some brewing momentum to do an over the counter drugs revamp in terms of how those drugs are approved by the fda meb doing user fees for that there's also been talk of fda sort of not fda congress i am doing a new sort of legislation that would affect how fda regulate lab developed tests devices that often times are not regulated by fda narch um different like labs or universities have a lot of freedom and developing so they could have more responsibilities them their plate m in 2018 yup also one more thing to look for uh that consumers can actually see in their daily lives as starting in may a restaurants are going to be required after like you know an eight year regulatory process uh to post calorie count son all of their menus a lot of them are already doing it but in may it seems that that will actually be the deadline that kicks in after numerous delays so uh that will be a visible sort of fda policy finally kicking into place um it so look for those calorie count sin don't complain to us when i heard every time i see a menu and there's something i wan looks delicious and then it's like a thousand calories.

public health food safety thousand calories eight year
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:01 min | 3 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Medical background so it'll be interesting to see how these different personalities come together to shape has fda he he made the point when i think the last question was who's the smartest person in the who's now working ministration he showered out peggy hamburg obama who bomb hair ahead of the fda so looking at his again ability to try build bridges across the aisle yet so on the on the food side i think we mentioned nutrition just what is fda looking to do on that front um it's just going to be very interesting to see how you know a trump fda approach is like using a food nutrition policy to tackle the obesity epidemic which is a basically what he said you know he would like to see the agency do more of a and then on this recall issue you you ask the commissioner about a recent i'm inspector general report which basically cited fda's long long delays in some of their recall proceedings for food food safety issues so one of the most agree just ones was there were seminole a nut butter as they knew were contaminated with salmonella anna took like a hundred and sixty five days to initiate a recall so there's these example sort of coming out of where the agency has fallen down in moving quickly to get unsafe food off the market and in reacting to this report the agency's kind of saying well you know we're going to look at more rolling out more information and really at giving companies more guidance going into 2018 so how they approach that will be really interesting because if they for example uh make companies or start one of the things they could do is mandate or or really unveil retailer information so if there is a food safety incident they might name you know target walmart safeway this is where it was sold in this locations they don't do that right now in the idea of doing that's kind of controversial even though usda already does it so if he were to move forward on something like that it would be really interesting to see how they would approach it right 'cause this you know how deby business friendly.

peggy hamburg obama commissioner safeway usda obesity fda food safety walmart sixty five days
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:02 min | 3 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Which they pay to get their products reviewed and through fda faster and that money can really only go to those bray particular activities so fda really has a very small budget to do a lot of regulation a lot of overseeing of manufacturing facilities safety of food safety of drugs a lot of the public health task that fda does and the amount of staff they can afford to work on these issues is pretty limited and oftentimes the money than dictates priorities and what is sort of in law guaranteed paid for tax pay that's not taxpayer money that you don't have to fight congress for every year can always get done pretty efficiently and everything else its what can they do with a very small budget it's it's interesting you make the point because having joe spin up at fda talking to the commissioner the feeling of campus is so different than sapien jr which is also another important agency but feels kind of look at university and in his sprawling an interest has like more of a hightech fuel in places you're looking at me possibly sceptically so maybe i'm wrong but i wouldn't the that isn't like hightech in in some ways like the main campus in white out to me feels really big but again and ages budget i think is about thirty two billion now year again fda six and of course i'm not saying i don't know what the right number would be or how much nih does verses fda it's just they do a lot of public health where they have a lot of responsibilities and most people generally agreed they're doing out on like a shoestring budget was there anything else or withdrawal leaves said about the form of sides zero that you thought because her former reporter was worth calling out you're one of the things that struck me as really interesting you guys talked about puerto rico and the situation there with drug manufacturing and you kind of asked him bowl like what should be done for future scenarios and storms in puerto rico ally.

food safety congress joe commissioner nih public health reporter puerto rico bray
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:02 min | 3 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"About toxicology and potentially get it earlier because doing animal studies takes a long time is just one example of many where if you're if you're incorporating good science you have the potential to uh to achieve both a more efficient result and maybe a better result so beyond just to safety and speed paradigms which may be the wrong way to think about this at all but the question about drugs that are helping people the efficacy of of a drug and some of the highest profile battles of the past few years have been around drugs like the female vie agra equivalent socalled hady or disrupt uh for folks with the kids with muscular jane's the question with those was not are they save as much as do the actually accomplish much and help people at the end of the day if the fda is allowing more drugs through what does it mean of those drugs don't actually lead to significant benefit so is that is that argument in your perspective one that holds any water is it up to the market to figure out once fda approves based on safety the market can kind of decide who gets access to these drugs are you talking about new you bake the lot of different construct sent to your question you know there's there you you sort of conflated we only have so much time trying to combine all these by hanson into one while they're without a fence hey you've you've completed the question of is a clinical benefit a meaningful enough benefit to justify taking a drug with the question of is the observed benefit um sort of statistically certain enough that you have confidence that the the um result you're seeing actually comport with the result you're gonna get those are two very different questions uh and i think that you know we have to deal with them differently from a policy standpoint if a drug provides a certain benefit even if it might be in the perception of some people you know not not a sort of transformative benefit but it's going to be a benefit for certain patients that something that traditionally we have left up to the clinical community and we've.

jane fda hanson
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

01:41 min | 3 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"Well base reject medicine goes back to when i was lasted fda more than a decade ago but now that we're seeing these products start to come to the market uh i think we have the opportunity to make sure those rules get put in place in an effective way and in a practical way their lousy innovation go forward stats that's one not not a very short headline best regetted while you it's your job to shorten a headline head handing the english have our roles as british against a i know that there will be folks who are following everything you're saying and then we've got listeners who might be college grad students who might not know cell based regenerative medicine sort of put a little bit more specifics around at you're talking about products like these are on things like adult stem cells things that allow you to regenerate certain tissue um so he could think of for example a damaged heart now after a patient has a heart attack and being able to implant cells back into the heart that allow you to reconstitute heart muscle or for example cells that would allow you to start producing normal levels are some level of insulin and after year uh you become a diabetic and your pancreas doesn't work so that's that's regenerate medicine um you know bleeds over into some of what's going on with respect to gene therapy as well the other headline i think if you're looking back um i would hope would be what we did on tobacco what we now stand tobacco this year i think that that has the potential to have you know a multigenerational public health impact uh obviously as a lot of work that that that is yet to be done in terms of gain that in place but uh i would hope that when people look back at this period of time a decade from now they point to that because that means we will have succeeded and you've got the adult cessation program underway and we'll we'll come back to dobacco in.

stem cells public health
"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

POLITICO's Pulse Check

02:08 min | 3 years ago

"commissioner scott gottlieb" Discussed on POLITICO's Pulse Check

"I'm dead diamond this is pulse check and that was president donald trump criticising the fda in his first speech to congress in february 2017 so how is the fda doing now and what are they doing under president trump that's the focus of today's episode rough speak with scout got leap highprofile fda commissioner about his work last year and what lies ahead for his agency then after the break i'll be joined by politicos lena a miller each and sarah karlin smith cover food and drugs respectively to analyse gottlieb's tenure at the agency in his remarks on this podcast just reminder you can find pulse check on all of your favorite podcast apps you can find me the week of january eighth in san francisco at the jp morgan healthcare conference where i will be with quitting several podcast an i'll be around to meet with any leicester's i met de diamond a politico dot com if your thoughts are feedback about our show with that here's fda commissioner scott gutless what are we start with this fda approved more than a thousand new generics last year it approved the first gene therapies there are a lot of first in 2017 if you were picking the headline for this agency last year what would it be i think the two things and if you're looking back that are gonna be the most profound in terms of what we did that's going to have i think a transformational impact potentially transformational impact on areas is going to be um what we did with respect to sell an and uh cellbased rejected medicine trying to put in place a modern framework for how we're going to bring those products to market going forward in a way that's uh you provides for consumer safety um this is a field i think holds a lot of promise but it's early days uh and so i think we have the opportunity now to write the modern rules for how that's going to go forward and that's not to say there hasn't already been a lot of work that's been done has been an enormous amount of work that's been done going back many years in law the w work trying to develop the the modern framework for.

donald trump fda scout commissioner gottlieb san francisco leicester gene therapies president congress sarah karlin smith jp morgan healthcare scott gutless
"commissioner scott gottlieb" Discussed on AP News

AP News

01:54 min | 4 years ago

"commissioner scott gottlieb" Discussed on AP News

"Get their hands on the pills in teenagers who experiment with drugs would be less likely to overdose in die if the high dose pills were off the market for the ep i'm chris macisaac with ribbit a harddrive belonging to lead fantasy writer terry pracha had contained his unpublished works that will likely now go on scene after a stipulation in is will was carried out rob wilkins manages terry pracha the state that he's the honored his wishes by destroying that hard drive with a steamroller wilkins posted a picture of himself nearest roller in tweeted about to fulfill my obligation to terry followed up with an image of a broken harddriving wrote the rules the browsing history the hard drive was crushed by a vintage steamroller named lord jericho what's left of the object will go on display of england salisbury museum in september as part of the exhibition terry prajet his world breteuil it is one of britain's bestloved authors who created the disc world series and wrote some seventy books he died in 2015 at the age of sixty six from earlyonset alzheimer's disease a breakthrough treatment for childhood leukemia has been approved in the united states fda commissioner scott gottlieb says it genetically engineers the patient's own blood cells to seek and destroy cancer cells that guy three to the point of departure he already where enough of the component aviv endeavour the worked out we can deliver objective barry debate we can deliver on the original crime it fda's cutter four biologics evaluation of research director peter marks explains how the gene therapy work therapy involves changing the gene her genetic makeup other cell in order to cure burnt treat disease for example in gene therapy my reply defective nonfunctioning lean and causes the theory to be with a healthy copying bad gene would either treat procured into the new vardis pharmaceuticals that the price with a.

united states research director barry commissioner fda writer chris macisaac peter marks scott gottlieb terry pracha leukemia alzheimer world series britain england salisbury museum lord jericho rob wilkins
"commissioner scott gottlieb" Discussed on AP News

AP News

01:32 min | 4 years ago

"commissioner scott gottlieb" Discussed on AP News

"Users over thirty two gigs a month may notice reduce speeds a woman died after police say a chinese tourist with no australian medical aisin's gave her an anaesthetic during a procedure and his sydney beauty clinic gene wong had been hospitalized in critical condition since undergoing a breast procedure at sydney's nettie beauty laser and kantor clinic and wednesday in a statement police said she died friday a 33yearold chinese woman was charged before hwang's death with causing requisite grievous bodily harm and using poison to endanger a person's life if prosecutors have thursday if one died the woman would face more serious charges police on friday said they were considering taking further legal action phone calls to the clinic friday we're not answer the healthcare complaints commissions investigating a breakthrough treatment for childhood leukemia has been approved in the united states fda commissioner scott gottlieb says it genetically engineers the patient's own blood cells to seek and destroy cancer cells that guy and could reach the point of very already where enough the component aviv endeavour the worked out we can deliver buried to patient we can deliver on the original crime it fda centreforward biologics evaluation of research director peter marks explains how the gene therapy works team therapy involves changing the gene genetic makeup other cell in order to cure britain treat disease for example in gene therapy my look by defective nonfunctioning greenland causes a theory to be healthy copying bad gene would either treat procured into the.

sydney leukemia united states scott gottlieb peter marks gene wong kantor clinic hwang fda commissioner research director