40 Burst results for "FDA"
Fresh update on "fda" discussed on News, Traffic and Weather
"Residents, but the black and Hispanic population is down a 22.7 as cases increase in the Northeast largely among younger residents. It's a race to vaccinate as many people as possible before the spike reaches here, but with eligibility, said to open up to everyone. There are still just not enough, does it? Illinois becomes the latest state on Monday to throw open its vaccination sites to everybody. 16 and older ABC is Jesse Kirsch reports starting Monday. Illinois is making anyone 16 and older eligible for getting their covert 19 vaccine 16 and 17 year olds they'll remember must get the Fizer shots because of the FDA emergency use authorization requirements. The state expects demand to increase Expanded eligibility and is asking people to have patients even as the state reports an average of 100,000 shots and arms each day. Chicago residents need to wait until April 19th to be fully eligible for a vaccine shot. Although they can go to a state run center and get their shots, Koma Radio news, stay connected. Stay.
Pfizer is asking that its vaccine authorization also cover 12 to 15 year olds
"Older kids and teens in the U. S. May soon be able to get visors coded 19 vaccine Isar asking the FDA to extend authorization of its vaccine for 12 to 15 year olds after the company reported it was safe and 100% effective. Maybe she's with Johnson says some kids could get vaccinated before fall. If approved, it'll be the first covert vaccine for kids in the US, the head of the FDA vaccine Advisory Committee says it's highly likely the vaccine will get
Fresh update on "fda" discussed on KOA Programming
"Music, radio and podcasts, all in one from ABC News. I'm Chuck's Iverson. Drastic action and it rising covert cases and deaths, especially in the Midwest Hot spot. ABC is Trevor. Also the federal government now sending Michigan more personnel to administer vaccines. The governor Gretchen Whitmer, doubling down that what her state needs is more shots. When there is a surge. We think that it's important that we we go toe we rush in To meet where that need is in the country, Bracing for an 85% drop in the supply of the Johnson and Johnson vaccine this week, a potential speed bump just as a record 4.6 million shots were reported on Saturday Administration not sending more shots to Michigan, saying the virus is unpredictable and you can't tell where the next hot spots will be. Action on police reform. Maryland's legislature just yesterday became the first to enact major changes restricting no knock warrants mandating body cameras and more this as the trial resumes tomorrow, the ex Minneapolis cop charged in the death of George Floyd, ABC News chief legal analyst Dan Abrams on the defense on Lee Doubt. I think that they can really focus on is this cause of death. They're going to try and call experts. We're going to talk about the fentanyl in his system. They're gonna have an expert who is going to say that this could have been considered an overdose. Now you've already seen from the prosecution's experts is It might be in someone else, but not in this particular person, so that's going to be the key to the defense. Some Republicans say they support a smaller infrastructure package than the one president Biden wants administration's indicated the effort could be broken up. What kind of support from fellow Republicans does Florida congressman Matt Gates have is he denies claims that he paid for sex and had sex with a minor. Maggie Haberman, New York Times White House correspondent on ABC is this week has very few defenders former President Trump is not defending him. There are federal law enforcement and House ethics committee investigations of Gates. Listening to ABC News, Okay. Await news. Radio Time is six. Oh, two. Tom Mustard. Ah Major vaccination milestone for Colorado. State announced more than two million Colorado's have received at least one dose of the cof in 19 vaccine, and more than 1.2 million have now been fully vaccinated. Governor Paul is called this the greatest national effort since World War two. He also urged those Colorado's who are not vaccinated to continue wearing masks and to practice social distancing. It's your health is pulling the Johnson and Johnson vaccine from three drive throughs. Vaccination sites, so terrorist, says 11 drivers reported bad reactions soon after getting the shot at Dick's Sporting goods Park in Commerce City. Right now. We're waiting CDC and FDA of evaluation of this incident. So, terrorist CEO Peter Banko tells Fox 31. The reactions ranged from dizziness, the nausea. Two people were sent to the hospital. Colorado is one of four states that reported reactions to the JJ vaccine, so terrorists as the vaccine is safe. And that it will offer the Jangi shot and its office locations just not where people are driving their cars. Ah, beautiful Sunday here in the front range, but in typical.
The Latest: Pfizer asks US to allow more kids to get vaccine
"Hi Mike Rossio reporting Fizer asked US regulators to allow more kids to get its covert nineteen vaccine Fizer read it's German partner have asked the U. S. food and drug administration to expand emergency use authorization of their covert nineteen vaccine to include adolescents from ages twelve to fifteen visor and buy on tech as he say they're working with the FDA and regulators in other countries to get emergency or conditional authorization for kids ages twelve through fifteen as quickly as possible visor in biotech say preliminary results from late stage testing found the vaccine safe and one hundred percent effective for that age group in December the FDA gave emergency clearance for the two dollars Fizer vaccine for people ages sixteen and older hi Mike Rossio
Fresh update on "fda" discussed on Fox News Sunday
"A recent report says nearly 40% of U. S. Marines have declined the covert vaccine data obtained by CNN show more than 75,000. Marines have gotten the vaccine while 48,000 have refused it. Because the shot only has emergency use authorization from the FDA. The military cannot require members to get it. Several U. S. Cities are prepared for white lives matter, Marches and rallies today. Police in New York for Worth, Chicago and Los Angeles are bracing for the demonstrations. Some black lives matter. Groups say they plan counter protests. A Mississippi senator says President Biden's proposed tax hike would deal a major blow to small business job creators across the U. S on a Bee sees this week, Republican Roger Wicker says he can't think of a worse thing to do for the economy. That's the latest I'm Cameron Fairchild. This is Bloomberg Business of Sports from Bloomberg Radio. Thanks so much for joining us. We're here each and every week for you the same time.
Pfizer Asking For Vaccine Authorization For Children Ages 12 to 15
"Today, Fizer asking regulators for permission to extend authorization to kids as young as 12. The Food and Drug Administration initially authorized the Fizer beyond TEC vaccine for use in anyone over 16. Fizer has been conducting clinical trials in those younger than that, and said the vaccine is safe and effective for 12 to 15 year Olds. Visor is now asking the FDA to amend its emergency use order to allow adolescents to be vaccinated. Guys who said it hopes to expand authorization of its vaccine in 12 to 15 year olds as quickly as possible. NBC's Aaron Carter
Fresh update on "fda" discussed on KDWN Programming
"Fast Mel d three formula A much better choice. Well, Chris, First of all, I put 5000 units of vitamin D three per serving in each tablet, you can actually feel the difference. Second, I use the right type of vitamin D in my formula and third. I've worked with an advanced team of scientists and they're using this technology to put it in this vast dissolving melt for immediate absorption. And quick results that you can feel now is your fast Mel vitamin D three formula of manufactured here in the U. S. Dr. Pincus. Yeah, absolutely. My formulas manufactured right here in the U. S. A Chris. In fact, we have a facility that is a C G MP certified lab, which means current good manufacturing practices. And this is an FDA mandated instead of rules that we follow. As a matter of fact, just recently, the FDA came in and did an inspection And they said, Hey, guys, keep up the good work now you meant Sins earlier that there's a strong connection between vitamin D and diabetes talk a little bit about how your fast Mel D three formula could help folks that are dealing with diabetes or even at risk of getting diabetes. Well, yeah, Diabetes is a huge problem and in type two diabetics, what we find is that there's plenty of insulin in the bodies, but the insulin is not recognized by the cells. And so what vitamin D three does is it takes that problem and it seems to fix it. Now They've studied vitamin D three. And it's improved this insulin signature by 60%. And just to give you comparison, the most popular diabetic drug improve that 13%. Now..
The Resurgence of Psychedelic Psychiatry
"I'm only here with. Npr science correspondent. john hamilton. hydro on me. So as npr's neuroscience reporter you're always reporting on the most interesting thing so what you got for us today. What i've got for you. Today is psychedelic drugs. Not literally of course. But i wanna talk about how these drugs are getting a second look as a way to treat psychiatric problems like depression anxiety substance use disorders. Even ptsd in the past decade. It's become a very hot topic. Brain sites yes. It is a very hot topic. In fact john. Our first shortwave episode was about using silla sivan as a treatment for smoking cessation. Some guy you're bringing this topic back to the podcast. What are some of the drugs will be talking about today. Lot of familiar names. You mentioned suicide side. There's also ketamine masculine. Ibew gain ecstasy even Lsd in some cases and those are all drugs that can cause hallucinations or out of body experiences. Right right and most of them are not legal right but how do they work for depression. And all those other psychiatric conditions so ketamine for example is able to help a lot of people with major depression even when nothing else works about ten years ago i was able to talk to one of the first people to take part in a clinical trial ketamine. His first name is christopher. He asked me not to use his last name. Christopher had depression that made him so aside uil and before he got ketamine he had been prescribed just about every drug out there to treat his depression he told me it started with prozac and paxil and went onto klarna pen atta van zanex ramen gabba penton byu spar depakote. They had me on for a while. That is a long list and none of those helped him either. They didn't work or the side effects. Were so bad. He had quit taking them. But christopher was lucky managed to get into one of the first studies of ketamine and now fifteen years later the fda has approved a version of ketamine for use in people like christopher.
Fresh update on "fda" discussed on Our Auto Expert
"Get the Fizer shots because of the FDA emergency use authorization requirements. The state expects demand to increase with expanded eligibility and is asking people to have patients even as the state reports an average of 100,000 shots and arms. Each day President Biden pressing his infrastructure plan. But Mississippi Senator Roger Wicker on ABC s this week among Republicans who say Trillion dollar number is way too high for me. Democrats say infrastructure is more than roads and bridges. Energy Secretary Jennifer Grant home, telling ABC News that the president may be open to breaking the infrastructure plan up into several smaller packages. Much of the Caribbean island of ST Vincent remains covered in ash following eruptions at the island's lawsuit for a volcano. Ash has been raining down as far as Barbados in ST Lucia, Barbados, Home Affairs Minister Wilford Abrams saying that the danger quickly evolve. You were concerned about a little dust, no Barbarouses kick, and that's Instead, Lucy itself night fell in the middle of the day yesterday on this is continually happening. You're listening to ABC news. Would you get on an airplane? If you knew it had a 50% chance of crashing? You may be riding that plane.
Can Companies Force Employees To Return To The Office?
"As vaccinations rise a growing number of employees or returning to the office. But what will your workplace look like. And can your company require you to get vaccinated. Here's joe lynn. Kent as companies planned to bring employees back to the office. The reality of returning is setting in. It is a little nerve wracking if my company like forces me to go back. I'm going to try to look for another job and the questions are piling up. How are you going to keep us safe. Have been vaccinated. Can an employer require you to come back to work. If you're getting the job done just fine at home. There's no reason that employer can't require employees to return back to work if they think that would be most effective even for employees who had been working productively efficiently while masks social distancing and reduced capacities will likely be required. What about vaccines three have been authorized by the fda for emergency use and full approvals are expected but can private companies mandate them. The law does permit an employer to require employees. Received even vaccine. That only has an easy way whether fully approved or not you have to make reasonable accommodations for people with disabilities or sincerely held religious beliefs and when the doors do reopened things will look very different. We installed uvc lights which basically as air comes into the building it kills all airborne pathogens and brings fresh air into the building at rio design firm in los angeles. They're also installing massive fans spacing out desks and opening garage door. What was their number one priority. Our primary priority was to really find a genuine way to do it for ourselves safety as a baseline but then we started to implement big ideas of really understanding what to do. And the office when you're coming in two days a week. What were we prioritizing in. Our work process one popular new strategy for employers new more personal desks instead reserve an empty desk ahead of time on an app.
FDA OKs first new ADHD drug in over a decade for children
"The food and drug administration approved the first new drug in over a decade for children with attention deficit hyperactivity disorder Calgary is for children ages six to seventeen with eighty HD it comes in a capsule and is taken daily it is not a stimulant or controlled substance making it harder to abuse than older drugs nearly all ADHD treatments like Ritalin contain the stimulants amphetamine or methylphenidate Calvary does carry a warning of potential for suicidal thoughts and behavior it happened in fewer than one percent of volunteers in studies of the drug a study funded by the maker of Calvary shows inattention and hyperactivity symptoms were reduced by about fifty percent in children ages six to eleven who took the drug for six weeks at Donahue Washington
Moderna to Fill Covid-19 Vaccine Vials with More Doses
"FDA is allowing changes that are expected to speed up delivery of modern is Cove IT vaccine, AP correspondent Mike Hampton With the News announced last night, the FDA says it is approved new vials from Moderna that can contain up to 15 doses each compared to the original vials designed to hold 10 doses. And regulators say providers can safely extract up to 11 doses from the 10 does files. The changes will bolster supplies and speed vaccinations as the U. S nearest 100 Million inoculations against Cove in 19. President Biden has vowed to provide enough shots to vaccinate all U. S. Adults by late May. Mike Hemp in Washington are
The Latest: Filipinos mark Good Friday with deserted streets
"The the food food and and drug drug administration administration is is authorizing authorizing changes changes to to modernise modernise covert covert nineteen nineteen vaccine vaccine that that will will provide provide extra extra doses doses from from each each file file the the FDA FDA says says it it has has approved approved new new files files from from journal journal that that can can contain contain up up to to fifteen fifteen doses doses each each compared compared to to the the original original files files designed designed to to hold hold ten ten doses doses and and regulators regulators say say providers providers can can safely safely extract extract up up to to eleven eleven doses doses from from the the ten ten does does files files the the changes changes will will bolster bolster supplies supplies and and speed speed vaccinations vaccinations it's it's the the U. U. S. S. near near its its one one hundred hundred million million and and accusations accusations against against covert covert nineteen nineteen president president Biden Biden has has filed filed to to provide provide enough enough shots shots to to vaccinate vaccinate all all U. U. S. S. adults adults by by late late may may might might help help in in Washington Washington
FDA Authorizes First COVID-19 Tests for Repeat, at-Home Screening
"The fda has authorized the first covid nineteen tests for repeated use. That can be used at home by people without symptoms over a few days. Two of the three newly authorized cereal tests don't require a prescription. The fda previously authorized such tests for use only by people with covid nineteen symptoms
The Latest: FDA authorizes 2 changes to Moderna’s vaccine
"The food and drug administration authorized changes to modernise covert nineteen vaccine that can provide extra doses from each bile moderna says it will start shipping new fifteen does vials of its corona vaccine in the coming weeks after showing the FDA different amounts of vaccine can be extracted from each vial using different types of syringes the original files were designed for ten doses and the FDA says providers actually can get eleven out of those files with new instructions it's sending to healthcare workers these dosing increases are expected to bolster U. S. supplies and help speed up the vaccination process president Biden is bad there will be enough shots to vaccinate every US adult by late may Jackie Quinn Washington
FDA authorizes rapid, non-prescription COVID-19 tests
"Rapid covert 19 tests will soon be for sale A chain pharmacies without prescription. The FDA approved to home tests capable of giving results in 10 to 15 minutes to others also approved but still need to go into mass production. Current tests require people to spend to send samples to a lab which can often delay the
US allows 2 more over-the-counter COVID-19 home tests
"Federal regulators are moving to expand the availability of cheap home tests for covert nineteen the FDA has authorized to more over the counter tests that can get quick results at home it says the test from abit and Quidel can now be sold without a prescription it approved both last year but limited their use experts have been pushing for more home testing since the pandemic's early days since frequent self testing is considered key to helping reopen schools offices and other facilities as vaccinations ramp up this move comes as testing numbers keep sliding even as new infections rise Sager made Donnie Washington
New study of Pfizer vaccine finds it's effective against South African variant
"The company says trials suggest it's vaccine is effective against a variant that first emerged in South Africa. Advisor says a new company study shows the vaccine more than 90% effective Six months after volunteers got their second dose. The drug maker says the new data likely is sufficient for the vaccine to meet full FDA approval criteria. Vaccinations are now available for anyone
Johnson & Johnson COVID-19 Vaccine Batch Fails Quality Check
"Ah Johnson and Johnson. Covert 19 Vaccine Batch fails A quality check CBS is Steve Futterman has details. Problem involves one batch of the J and J vaccine is reportedly effects around 15 million doses. According to the drugmaker, an ingredient in its vaccine was manufactured in a factory that had not been approved by the FDA. For the moment, the company says it's halted future shipments. But Johnson Johnson says it still expects to deliver more than one billion doses of its vaccine by the end
Pfizer Says COVID-19 Vaccine Highly Effective In Children
"Now says its covid. Nineteen shots are extremely effective in children as well. The vaccine maker released results from its final phase trial in adolescence in this trial. More than a thousand kids ages. Twelve to fifteen got both doses of the vaccine and in the end the company says not one of them tested positive for covid nineteen and they did not experience any serious side effects just like with adults. Some reported having fatigue fever. That did go away now. All this data still needs to be reviewed by independent researchers then the fda will have to authorize the shots for kids here in the us experts. Say if all goes well children. Twelve enough could be eligible to get shots by the
Pfizer says COVID-19 vaccine safe for kids as young as 12
"Vaccine is effective in kids, The company says A phase three trial has found It's covert 19 shot is 100% effective in kids ages. 12 to 15 5 Years. CEO says the company plans to submit some new data on the vaccine to the FDA and hopes to have kids be able to be vaccinated before the new school year starts. Illinois will wait to begin the
Pfizer says its COVID-19 vaccine protects younger teens
"Pfizer is announcing a step toward possibly vaccinating some kids for the corona virus before school resumes in the fall Pfizer says a preliminary U. S. study shows its covert nineteen vaccine is safe and strongly protective in kids as young as twelve right now the vaccines only authorized for those sixteen and older but vaccinating kids of all ages will be critical to stopping the pandemic and helping schools returned to some normalcy Pfizer and its German partner say they'll seek emergency approval to use the shots and kids starting at age twelve Madeira's expecting results soon from a study of its vaccine in twelve to seventeen year olds the FDA's already leading both companies start studying affects in kids eleven and younger Sager mag army Washington
Pfizer says its COVID-19 vaccine is 100% in young teens
"Pfizer says it's Corona virus vaccine is effective in kids. The company says it face three trial found its covert 19 shot to be 100% effective. In kids ages. 12 to 15 Visors CEO says the company plans to submit this new data on the vaccine to the FDA and other regulators as soon as possible. He says he hopes Children in that age group will be able to be vaccinated before the new school year starts.
"fda" Discussed on In the Bubble with Andy Slavitt
"That the FDA did what it said it was going to do it followed a process even if it's a little bit form-over-substance, a bit of enhances trust the vaccine from. Forty. Percent to seventy percent or some numbers which has as much to do with the vaccine effectiveness and achieving her immunity as the effectiveness of the drug. You buy my argument that's just as important a factor for the to take into account. I think it's a valid point of view and I mean you're pushing me to say what I would do if I were. In the job and you know what I would do is to try to get the trials done as quickly as possible. And have us out of interim analysis roles were clear and established ahead of time, and they would not be driven by an election day there'd be driven by the percent completeness of the data. That's the way we normally do interim analysis. In clinical trials, I'm just saying that if someone makes that decision, it's really important for us not to let politics on the other side, the Anti President side deny the public vaccine could say why? So that's all I'm saying. Yeah. That's exactly right. Anything else we should've talked about anything trapped you into saying that you wish you hadn't said that we can. We should add. Anything that I. Know You did new I'm so used to being questioned, but you know you are. So you're more judicious than I've ever seen. Well. You're you're you're you're very political host Air India I don't think I was being political. I don't think he's being political I. Really don't I think people are confused and I really worry about long-term trust in vaccines. and. If I'm suggesting that I think President Trump is inclined to interfere in the FDA. You think that's a political statement that's not a political statement. You're being provocative in the way you ask the questions, but that's that's fine that's because I was wasn't getting you guys were all for you wasn't getting clarity for folks on what it meant and whether or not we were in a strange spot or not, and I still don't think we still don't think you guys gave clarity but you know I. Think you guys did the best you could given. Given that you know it's there's limitations on your ability to be effective with the commissioner and as a public voice doesn't allow you. To not be even handed and provide even ended answers and I totally get that and I and I, totally respect that. All right man. Hopefully, it'll be helpful to some people that want to get sort of a balanced sense of. Where this God thank you so much. Appreciate it buddy. By. All.
"fda" Discussed on In the Bubble with Andy Slavitt
"It's clear out for the country the message that get Kinda muddled the beginning, which is that that basks do help they do reduce the spread and I think having one that is both comfortable reasonable etc, etc. so a product like that walk through the optimal way for a product that to go through the process. Well, first off I, really appreciate all you've done and try to encourage people to. Wear masks to keep that six foot distance avoid big groups if just about all of us did that we'd be in much better shape for the pandemic. That's that's a that's an opportunity that's still there and we all need to keep working on together and you don't actually have to get FDA approval to start wearing a mask or the FDA comes in as if the mask manufacturer wants to be clear that that you know their product has a differential benefit differential factum for healthcare workers you. Know there were there's the so called in ninety five mass that were in short supply earlier FDA took some steps to get additional kinds of massive prove with an ninety five quality. They rejected a lot of mass to that claim to be that good and and really weren't and they also approve some ways of reusing these these e ohi medical grade. You know a emergency covert setting mass and it's possible to get some claims maybe below that level along the lines that that you're describing. And I think it could make a difference that the most important thing is that people should wear masks and remember that not all mass or created equal. The really thin ones are not so good the ones with Vance or definitely not good for protecting people around you. And that the more progress we can make, and hopefully FDA can can help us get there with mass that do a good job of of stopping droplets and that are easy to wear the better. So this is another of the many many ways in which FDA regulatory oversight Don in a way that keeps up with the science and the needs the pandemic is critically important. Thanks mark. You gotTa Run Robin. I'll finish up and We'll talk about your catch up.
"fda" 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" 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.
"fda" Discussed on POLITICO's Pulse Check
"I told you before when you asked me this question about a year ago, which is I'm very happy and the job I'm in and I will say beyond that. I think I'm in the job that I'm best suited for. I mean, this is the place where I think I'm going to, you know, deliver the best work for the administration and for the public health. You referenced our conversation on this podcast about a year ago. I asked you at that time to give a headline for what you thought the agencies work was if you were picking the headlines as a as a newspaper editor you responded with more of an essay than a headline. But that's just a quibble if you were picking the headline for twenty eight teen with the you're almost over. What would that be for FDA? You know, the headlines ends up being issue specific, I think that we've done some pretty bold things and things that are going to have a pretty broad impact on public health in a couple of different areas. I think that work that we've done in in tobacco is notable, frankly. And I think it's going to have a meaningful impact in perpetuity. I think the things that we've done to try to shift the agency. Orientation to the opioid crisis and think differently about what roll is with respect to that crisis are going to have a lasting impact. I hope they will. And I think some of the work we've done to try to promote competition are also going to have lasting impact. I look at it from the from the standpoint, if you're asking me what I think of the most notable things that we've done I look at it from the standpoint where I feel that we have changed the agency's relationship to important issues and with the agencies now thinking differently about its mission with respect to those issues, and those are three areas with agencies now thinking differently with respect to those issues through the work that we you know, that we've done together that that I've done with the leadership of the centers. Is an essay. It's the headline and the first couple of paragraphs of historic. We'll give you credit for over achieving and delivering more than than the editor asked for. Let's let's go through those interns who tobacco and even beyond tobacco Easter 'grats. And what the FDA is is doing in that area. This is a real life problem in a way that say Medicare payment regulations might not be I get emails from readers who say I am. I am worried about my teenage son or daughter using jewels vaping and in school. I don't get that same level of urgency around like the discrete regulations that are happening. You've said that FDA has data showing that use of of ping devices among teenagers, isn't ethnic. What do you know? And when will we find out about it is going to be coming up very soon? We're going to announce action next week. The first stages of our action next week in terms of what we're going to do to try to address the epidemic of teen use of cigarettes. And I've already said the data shows a greater than seventy five percent increase in the use of cigarettes. Year-over-year from twenty seventeen to twenty eighteen among high school students and about a fifty percent increase in the use of cigarettes among middle school students in this comes from the national youth tobacco survey. This is early data from the national youth tobacco survey where we looked specifically at the east cigarette. Use based on concerning trends that we spotted you know, and and it's not just that uses gone up, but but regularly uses gone up..
"fda" 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.
"fda" 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.
"fda" 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.
"fda" Discussed on POLITICO's Pulse Check
"Not on the political the it's the food and drug administration how much mindshare how much effort is on food verses drugs and and you may have different perspectives based on where you cut i'll start with that this is wholly now i think food is always the like neglected stepchild not say anything bad about stepchildren but um food has just historically been a a less important less or lower profile less funded you know there isn't this historical reliance on user fees so i it has been um just less of a focus and even during the obama administration when they were so active nutrition you didn't see act commissioner hamburg for example talking at probably as often about nutrition as gottlieb already has which is interesting but but as some of that because we've got the department of agriculture dealing with food issues and after use under the health department which is health alerts it's weird because fdi actually has eighty percent of the food supply even so usda does at meat and poultry and they do cracked eggs but a fda does whole eggs and there's all these weird jurisdictional lines so fda has uh most of you know most of the food supply including labeling and nutrition facts and you know declaring allergens and all of that but it's just not intel really i think there's been a big new focus after the food safety modernisation act which was passed in 2011 to kind of be more proactive on food safety issues there is definitely more focus on you trish in so it's kind of coming into its own as a top line fda issue but historically i don't think it really however member fdic regulates people debate exactly whether it's like one 25 sense of like every dollar consumer spender twenty cents of every dollar consumer spent but it's a very very low funded agency its budget is like around six billion or so a year and about half of that tends to come from user fees and user fees are fees that drug companies primarily are the big pair of that.
"fda" Discussed on POLITICO's Pulse Check
"Over the course of this year is promulgating putting forward additional guidance um policy guidance that's going to allow us to make more information available at the time of recall so there's been some concern that when we recall a product we talk about the product in a manufacturer we give skew codes uh so people can identifier store shelf but if you happen to receive that product from a restaurant or a school or some other venue you might not know that you had to recalled product we think that we could provide more information we're going to look for ways to do that and so we're going to be doing taking additional steps of the course of this year to improve our recall process but i do think it has improved substantially from the time period that that report looked at you seemed to hint a statement after the idea report came out that fda might be naming which retailer sold recalled food usda already routinely does that you dealt are you going to be changing our policy of there well that's what i'm that's the policy guidance suggesting we're we're gonna look to provide more information around where you might have received a recalled product now remember usda does that because the product a meat product isn't identifiable by the meat product it's only identifiable by where the meat product came from a food product that we regulate most the food products we regulate i readily identifiable by the packaging you don't need to know the source of the product to know that you might have received the product so it's a different regulatory paradigm that that that said that's why there is a distinction between how fda has historically operate and how usda has but accepting that we are going to look at how we can provide more information around food recalls to that consumers who might have received a recalled product at a restaurant for example are able to know that they might have received it so we've talked about the food side let's switch back over to the the drug side of the brain and talking about all of the drugs that have been approved this has been a major success point but the flip side is there are concerns they may be too many medicines are getting through in this is the safety speed paradigm that fda always russel's with what what is the number of drug.
"fda" Discussed on POLITICO's Pulse Check
"Out break i those five reports of an outbreak that are unrelated to each other are those the first five reports of what are going to become hundreds maybe thousands of reports and you don't know where you are sometimes in the throes of of of of emergence like that of a poor like that um and that's that's why you need to focus on that you need to ask card questions you need to spend time on it you need make sure people are doing what they need to be doing we had such a report last week um hand gino again were its early days and we don't know are we at the beginning are we at the end is it related to one product is it just some sporadic reporting related to multiple products those are the patterns many to discern and and that's important function that the fda place um the way we do it has to make sure that people are doing what they need to be there is the ongoing question about fda getting food off shelves fast enough there is an inspector general's report just last month on this issue more than one hundred sixty five days to initiate or one hundred sixty five days to initiate a recall for salmonella contaminated nut butter what what does fda need in terms of resources power to move faster when there are products that might be contaminated lament may produce in perspective if i can um one one recall that isn't done appropriately are efficiently as one too many uh so we take this very seriously uh any any examination of our recall process where where there is evidence that we didn't move quickly enough especially with a potentially dangerous pathogen now that said this was an examination of thirty recalls conducted between 2012 and 2015 of literally thousands conducted over that time period and it was thirty of the most complex recalls sit thirty of the most difficult to execute recalls we clearly didn't do well uh we certainly didn't do as well as we should have do i think it's representative of the overall programme i do not i also think we have put in place and will contain a put in place a lot of process improvements to get even better one of the things we're going to be looking at doing.
"fda" Discussed on POLITICO's Pulse Check
"Schumer's comes across in your dealings on capitol hill does that he you and your office it's a good question i i think that um there is a certain challenge to to sort of adopt the premise of your question in that and it it transcends any administration that policy often gets viewed through um some element of a political lands and so if you take the exact same policy and you do it in a republican administration reverses you do in a democratic administration it gets perceived differently and and you know to some some in some respect the press is guilty of this to a certain times they they look at things through a certain lands and so i think from from my standpoint you know where a lot of our the the important role we play is speaking directly to consumers to patients to providers i think we need to look for ways to transcend that that political filter uh to make sure that things aren't getting misjudged or or not perceived appropriately because have getting that communication right is a critic go aspect of a public health function i will say in my role as a reporter having written about alternatives to fda their critics in every sector some who say fda moves to fast some say to slow very few say just right but the current mood around fda is incredibly positive and that comes from folks who are progressives who are were liberals were not inclined to approve of hhs more broadly but like what they're seeing coming out of fda your role as commissioner i'm i'm curious i notes cliche to say that new two days are are the same in any big job but how do you a portion your schedule when you could be doing and touching so many different sectors of of the economy of the healthcare space uh l.
"fda" 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.
"fda" Discussed on Psychedelic Salon
"With ptsd it's not that we had to argue to the fda there's a bunch of people with whom we actually had a um a a mother when we are doing the first mdma study say that her daughter had been raped at a young age and was mute and she was only 16 at she it was earlier that but you sixteen at the time and so we apply to the fda for an exception to enroll her the study and the fda said no we had to complete the study in adults first but there are so many drugs that are approved by the fda that are being used off label in kids that the fda now unless there's some real talks this city issue like sometimes with cancer drugs their requiring sponsors to come up with a plan for doing study and allison's so we're we're actually requesting a waiver to do with that we don't have to do studies between zero and eleven ages and the methods of measuring p to see are not validated in those ages anyway but we're going to be proposing twelve to seventeen we can already go down to eighteen and we've negotiated successfully that we don't have to start that study until after the drug is approved so there will be us another series of discussions and negotiations with fda on additional studies the other question that the fc is gonna want us to address is what about the fact that we have three mdma sessions we have these forty hours a therapy but some people might need a foursession in some people might be successfully treated.
"fda" Discussed on Psychedelic Salon
"This that where you're going with what you were just talking about no not really what i'm basically saying is we have to become big firm on so i'm saying we need to play the game i think working with the system working with the fda so maps is a nonprofit pharmaceutical company and we are negotiating with fda about the right to market mdma as a prescription medicine the the difference is that we're not out to maximize profits were out to maximize social benefit and so we're not try it we there's no for all the people that work with us we don't have nondisclosure agreements we don't have any kind of confidentiality there's no secrets they after protect so in many ways is the opposite of big pharma but it is playing by the same rules and trying to work with in the system that big pharma works within and there's so i think that's an important distinction the the other way to say it to is that once mdma it once maps makes empty main to a madison then what we wanna do is sell it as a madison it would be maps and we also want to sell it for a bit more than it costs us so that we can instead of constantly going to donors and saying give us money we're a rare nonprofit in that we're talking about having a product at the end and there's a program that the fda has there was ironically developed by signed into law by eager reagan so that if you're working with a drug that is off pat mdma was invented the 1912 by merck.
"fda" Discussed on Psychedelic Salon
"That tend to work more and women and not in man and didn't work whenever they used it for combat that mdma worked for related ptsd and mdma worked for complex ptsd and mdma worked for ptsd from accidents and so from the starting in two thousand to two thousand sixteen we completed a whole series of phase two pilot studies the purpose of which is to figure out how to design face three and face three or the pivotal studies that are required to make a drug into a madison so under member 29th two thousand sixteen we went before the fda for what's called an end of phase two meeting and we had incredible we treat at one hundred and seven people and we also had developed new relationships with the two groups of people that were crucial to our negotiations as i said we started this and 1980 sex and it was thirty years before the end to face to meeting and during that time some of the key people with fda that we had been working with had retired and so through a chance meeting that i had with john with the daughter of one of the people from fda who was subsequently a job at letran it frontier um we were able to get in touch with her father and other so we have several senior fda officials who worked at the division of psychiatry products were now consulting with us to help us work with fda and they've trained the people that are now in charge two of the division of psychiatry products.
"fda" Discussed on Psychedelic Salon
"Be a legal psychedelic therapist so it took a six years from eighty six to ninety two to get the first protocol approved by the fda they rejected five protocols before then and it wasn't so much that are sixth protocol was way better than the others what happened was that the people at the fda that regulated psychedelic s switched in a new group took over in this new group decided that science over politics and they would permit psychedelic some marijuana research to start but it also happened is that i had tried to get into a clinical sake phd program to learn about how did you psychotherapy outcome research with mdma nobody would let me end this is the late nineteen 80s and so i was blocked i'd been since seventy two to eighty eight i'd been thinking this is what i want to do and now i can't do it so i decided to smoke some pot and think it over and it's it's a really good technique the many of us know when you're in a box to threat questioned your assumption so i was under the influence of pot iit was like i wanna do this i want to much too soon the science is being blocked by the politics maybe i should switch and study the politics so it is i wear am i gonna stay politics harvard kennedy school government i knew of a professor they're and so eventually i managed to talk to him i managed to get in so i have this masters impeach d from the kennedy school government with a focus on the regulation of the medical use of second alex and while i was there for my master's i got home what's called the presidential management fellowship for people want a career in the federal government i kind of thumb managed to use the credibility of the kennedy school and get into this program and i have done i tried to get a job at the fda and and you can see how i'm dress now which is how i like to be addressed but i was willing to give up drugs wear a suit and go into work at the fda.