40 Burst results for "Fda"
Fresh update on "fda" discussed on KC O'Dea Show
"Phasers application for an emergency use authorization. Than Human Services Secretary Alex Cesar because of the president's support of Operation works speed because of the incredible work of the U. S. Military public servants of every level of government on the brilliance of American scientists way have an end in sight. The FDA is Vaccine Advisory committee provides advice about whether to authorize the vaccine for emergency use. But the final decision is made by the FDA Commissioner, California system for paying unemployment benefits is so dysfunctional the state approved more than $140 million for at least 20,000 prisoners. Detailing a scheme that resulted in claims filed in the names of well known convicted murderers like Scott Peterson, authorities say From March to August, more than 35,000 inmates were named in claims filed with the California Employment Development Department with more than 20,000 being paid. If you need help hanging your Christmas lights. Walmarts wants to help, but it's going to cost you. The retailer will not only deliver your fresh live tree, but we'll hang houselights installation is $129 for single story homes and 202 story homes. But putting them up is only part of the cost. Removal of the lights is $99 for a single story home and 159 for a two story home. And the lights are not included in the cost. My mom does this on the side. Burn her girlfriends? Yes, climbs. Ladders, installs the ornaments on trees $300 to put him up and down. She does not. She's far cheaper than that, as you might imagine, And just doesn't know She loves it. Mom, Please be careful. No ladder. I don't need that phone.
Amazon Launches Online Pharmacy, Shakes Up Healthcare Industry
"Amazon made big news last week when it announced the opening of its online pharmacy in a dark twist. The announcement appears to be timed perfectly as of this writing. More than twelve million cases of covid nineteen have been confirmed in the us according to nbc news and the country is averaging close to two hundred thousand new cases a day that adds up to a mammoth need for prescriptions. On top of that fewer and fewer of us want to venture out and those who are sick can't while the news is hardly unexpected amazon. Spent seven hundred fifty million dollars to buy pill pack in two thousand eighteen. That startup specializes in divvying. Up prescriptions into packets intended to make taking multiple prescriptions easier for patients but it was the infrastructure and logistics. That pill packet already built. There was to serve as the foundation for amazon's new online pharmacy business regardless of whether the announcement was expected or not. It's still hit. The healthcare industry hard with observers reacting both positively and negatively amazon says it's pharmacy will accept insurance and payment through flexible spending in health savings accounts. It will adhere to hip a privacy rules around patient data. One of the biggest draws without insurance or prescription drug benefits for prime members. Paying cash amazon is offering huge discounts. Forty percent off on branded drugs and eighty percent off on generics two day shipping is free for prime members others get five days shipping for free but can pay a few bucks to speed it up. Two days. amazon will fulfil most medicines including birth control. But it won't sell schedule two drugs which include but perhaps the biggest innovation is something healthcare consumer have been wanting for a long time a step toward pricing transparency. The retail giant says consumers will be able to compare drug prices at checkout both with insurance. And without you know just like we can with. Tv's books and blue jeans. One caveat drug pricing is a black box and it will still be hard to tell where those prices are actually coming from. The three billion dollar american drug business is highly influenced by pharmacy benefit managers or p. b. m.'s. Middlemen who negotiate prices with manufacturers insurance companies and retailers to get its pharmacy online amazon must navigate these murky waters to as the wall street journal reported amazon's announcement sent ribald stock prices plunging. Cvs drop nine percent. Walgreens boots ten amazon is stalking pharmacies. Now the journals. Charlie grant reported and shareholders are rightly spooked shareholders. See amazon is a threat to these. Retailers dominance as well as to walmart where many patients fill prescriptions. Don't count out. Cbs in the others just yet. However two years ago as amazon was gobbling up hill pack both cvs and walgreens announced same day prescription delivery and in march when the pandemic hit they wave home delivery fees altogether. And here's the other thing is still fill their prescriptions in person. The journal reported. That's a habit that could be hard for amazon. To change the specially among seniors and cbs in particular has been building in more and more reasons for us to walk into their stores namely health clinics most. Cbs is now have clinics on site where you can go for covid tests among other things one can only do in person and yes you got it vaccines. According to see an cvs is gearing up to offer twenty five million covid nineteen vaccinations a month. The first tranche in december depending on fda approvals. We'll go to nursing. But the average person should be able to get the vaccine beginning next february or march. Cbs chief medical officer. Dr troy brennan told cnn. And if you're walking into a brick and mortar pharmacy you'll probably fill your other prescriptions there as well while you buy makeup paper towels and the cat food. You've run out of right. Vaccinations urgent care. Visits are something. The world's biggest digital shopping mall can't compete with at least not now in the future we'll amazon at pharmacies to its whole foods and amazon. Fresh brick and mortar stores. You know that. Cvs and walgreens watching for that additional threat to appear very very closely
Fresh "Fda" from Steve and Ted
"Dot com and through the radio dot com app. Until you're smart speaker to placate it, says radio. You could listen to what Utah's number one talk all day. Sure, and many folks too. Yeah, a lot of different ways to skin the cat. As we say. The head of the C D. Don't say that. Okay. This head of the CDC says a Corona virus vaccine could be arriving very soon and just in time for Christmas. Tuesday, CDC director Robert Redfield told Fox News of vaccine would roll out, probably by the end of the second week in December. Well. No vaccine has been approved. Yet. The FDA will meet December 10th to decide whether to grant emergency authorization to fighters vaccine, which the company says is about 95% effective in late stage testing. Redfield says the first batches of vaccine would go to nursing home residents and health care workers and that hopefully, by March, we'll start to see the vaccine available to the general public. So The 1st 1st responders, people that could be by the end of my Christmas time to it. That's amazing. You want to be if you get into the false hopes, but it's sure six looks encouraging, doesn't it? Wanna go over the specifics of the what's going on here in Sedgwick County? Okay, We've been course Radley Price has been reporting on this, but I don't want to go over one more time. Exactly what's going on Sedgewick County now with 20,000 confirmed cases of cover 1949 related deaths. And so the county is trying to do whatever it can to get this. Stop the order doubt that will be in effect. It starts 12 A.m. 12 01 A.m. Friday the 27th. Ah, and goes to 11 59 PM Saturday, January 9th 2021, of course. If something happens between now and then something good, maybe it'll they'll pull back from it. Here's Here's the deal. Mass gatherings are limited to 25 total individuals. People must still be mashed and maintain 6 FT of social distancing. Um, fitness centers are.
Dr Fauci on herd immunity
"Dr. Fauci, what is herd immunity, and when do you expect the United States to get there? Well, herd immunity. You know, sometimes the the terminology is we use can confuse people. What herd Immunity means is that when you get a certain percentage Of the population that is protected against infection, either by natural infection, and we're not even close to herd immunity now as proven By the fact that we have had spikes in areas that have previous spikes, so the previous spike didn't prevent them from the subsequent spike. So herd immunity is when you get a large proportion of the population that's protected, which means those who are vulnerable and not either the vaccine doesn't work in them. They have a biggest susceptibility to getting adverse effects of an indelicate, eerie is consequence of the infection. The fact that you have so many people that are protected the virus. If you want to use a metaphor has no place to go. It's looking for vulnerable people, and most of the population is protected. That's how viruses die out. That's how we smashed measles. That's how we smashed polio. That's how we smashed smallpox. So that's the reason why you have an efficacious vaccine. You want to get his many people protected so that it's almost like if you have heard of strong animals. You see it in the movies about going into Africa and the beautiful scenery you see about herds of wildebeest or what have you You have the herd that's really strong. You have some weak ones in there. So when someone maybe the metaphorical lions trying to get in there and take care of the weak ones, the strength of the herd protects the vulnerable ones. That's what you mean by herd immunity. So it's a question of Two components and efficacious vaccine and getting as many people vaccinated as you possibly can. Those two combinations together, those two ingredients could protect everyone which gets to another important question that people keep asking. We've got to make sure we engage the community. To realize that the decision about the safety and the efficacy of the vaccine and the speed with which we did it. The speed was based on very exquisite scientific advances and an enormous amount of resource is that would put into operation warp speed to make this happen? There was no compromise of safety. Nor was there compromise of scientific integrity. Now we've got to get that was real. Yeah, the decision. I right, Go ahead. Now. Let me just say it. I didn't mean to interrupt this decision to say that this vaccine is safe and effective. The data were analyzed by a completely independent board. The Datum Safety Monitoring board, which in fact doesn't have to answer to the administration doesn't have to answer to the company. They're independent. They look at the data and they said in Both of those vaccines, both the Madonna and the and the Fiza that it is official efficacious and it's safe and to protect you, even against serious disease. Those data then get analyzed by career scientists that the FDA in association with an advisory committee that again is independent. When that decision is made. All of the data is going to be seen by scientists like myself and my colleagues, so the process is independent and it's transparent. So I know there's been a lot of mixed messages that maybe have come out. But one needs to appreciate that. This is a solid process. So when they say that the vaccine is safe and effective, if we want to protect the individual and all of our society, we should take the vaccine and I could tell you when my turn comes up. And the FDA says that this is safe and effective. I myself will get vaccinated and I will recommend that my family gets
Fresh update on "fda" discussed on Colorado's Morning News with April Zesbaugh and Marty Lenz
"Our first our earliest indication that some of the actions that Coloradans are taking Are making a difference. State epidemiologist Rachel Herlihy, she says It's too early to tell if the numbers indicate a date a blip or a downward trend in cases and if that is really developing Hurley, he says, If we aren't careful at Thanksgiving, we could see another rapid increase in new covered 19 cases. There's also a concern over deaths. Hurley, he says. On the current trajectory, we could double the amount of people dead from covert 19 in the state that could come by the end of the year. Currently, more than 2200 deaths are being attributed to the illness in Colorado Health and Human Services Secretary Alex Cesar says Corona virus vaccine distribution could begin after the FDA meets on December 10th. We believe we can distribute vaccines, all 64 jurisdictions within 24 hours of FDA authorization. During an operation works speed briefing is our said they're prepared to distribute vaccines soon after that. FDA meeting to consider drugmaker Fighters request for emergency use authorization The politics President elect Joe Biden Road map in his 1st 100 days in office and a sit down interview with NBC, he says, rolling back some of Trump's air policies there Gonna be a priority also be moving to do away with some of the I think very damaging executive orders that have significantly impacted on making the climate worse and making us less healthy from methane to a whole range of things. The president's done. The president elect says he will also push forward a pathway for citizenship for undocumented immigrants in the U. S. The interview was Biden's first since becoming the projected winner of the race for the White House. I'll bide maps out his administration recounts were still taking place in to Wisconsin counties recounts taking place in too strongly. Democratic counties Milwaukee and Dane. Nearly 400 ballots were found in Milwaukee Tuesday. There were never open election officials blaming human error. Six observers of the recount have been removed in the past three days. Some for not wearing a mask, others over physical altercations. So far, the recount has left the vote total little changed, biting one by over 20,000 votes. Republicans suing to try and stop certification Marco Malard ABC News, The Colorado chapter of the Council on American Islamic Relations, is putting up another $10,000 for information leading to an arrest and conviction. In the August fire that killed five members of the Muslim family from Senegal. Krista Cole is the group's acting board chair. It would be a tremendous burden off of them if they could just know that the perpetrators were arrested, because frankly, no one can feel safe in this community..
Health secretary says vaccine distribution could begin within weeks
"Virus vaccine test results. The FDA will meet on December 10th tow look at the results of these recent trials. If all goes well operation warp speed can begin vaccine distribution within 24 hours of authorization. CVS Health has said it expects to begin vaccinating residents of nursing homes within 48 hours after FDA authorization. Fox's Jennifer Griffin reports the US had already has purchase agreements in place for up to 300 million doses. Of the AstraZeneca vaccine, a federal judge has ruled the state of California cannot
Fresh update on "fda" discussed on KC O'Dea Show
"Food banks could do a lot more with the cash, especially since they can buy goods wholesale and stretched the money much farther than ordinary donors can It's eight minutes now in front of the hour on this morning Once again, here's Jennifer Cash Enka and now the three big things you need to know Number one. Now that the General Services Administration has determined President elect Joe Biden may access the transition tools of the federal government formal conversations. Between Biden's team and Trump Administration officials are underway. Third run very forthcoming. Offering. All access and so we're gonna be starting those on a regular basis. Biden says he can now access the daily briefings and his team is working out a meeting on vaccine distribution number two more than 2100 Covert 19 deaths were reported in the U. S on Tuesday, making it the highest single day death toll in the country has seen since early May. For the 15th consecutive day, the U. S beat its own hospitalization record with more than 88,000. Number three as many of 6.4 million doses of a krone. Virus vaccine may be shipped out in the first day after the FDA authorizes it. Health and Human Services Secretary Alex Cesar says that could be within three weeks. The American people could be confident that hope and help Are on the way down. Industrials closed above 30,000 points.
Health secretary says vaccine distribution could begin within weeks
"Secretary, Alex Cesar today saying that Cove it vaccine distribution could begin right after the Food and Drug Administration meets under 7/10. CVS health. Has said that they expect to be vaccinating residents of nursing homes, one of the top priority groups within 48 hours after FDA authorization,
Fresh update on "fda" discussed on Ron St. Pierre
"Reminder as spike and coronavirus cases from Thanksgiving won't show up until December. Kind of Cyrus from NBC 10 U. S government's carrying out a trial run of Corona virus vaccine distribution. This week, shipments will be sent to state health departments. So they won't have any actual vaccine. The goal is to ensure everything goes smoothly as Fizer waits on emergency approval. The FDA is meeting December the 10th doses could be available. Couple of days after that, too. So hey, it doesn't hurt to have a dry run, even though the actual vaccines not going to be in the cases stands 7 40. Let's go to the roadways. Once again check on the traffic flow on the traffic center. It's John Hampton. He's brought to us by compassion. International roadwork to watch for in Glen Bridge Avenue in the city, working on the Glenn Bridge Avenue Bridge traffic getting.
Anticipating the Logistics of a COVID-19 Vaccination Effort
"You have a highly efficacious vaccine and only a relatively small forty fifty percent of the people get vaccinated. You're not gonna get the herd immunity. You need what we do need is we need to get as many people as possible vaccinated so a lot of work still to be done. As we mentioned astrazeneca today joined pfizer and moderna becoming the third maker now of a highly effective vaccine candidate. Their version said to be cheaper easier to transport one of the that wants the vaccines are fda approved. The next challenge will be actually getting shots into arms across our country and around. The world complicating matters. The trump administration has so far not communicated distribution plans with the incoming biden administration. Back with us again tonight. Is mike oester home. Professor and the director for the center of infectious disease research and policy university of minnesota also happens to be a newly named member of the president-elect's covert nineteen advisory board. Michael i presume this helps that up. Twenty day wait to get your hands on. Everything is better than maybe a forty day weight. And i'm not sure our audience understands you've been forbidden from calling your public health counterparts inside this sitting government before we got actual notification that the transition is underway. So does this help. Thank you brian. It helps a lot. The transition team will immediately begin reaching out to those federal partners. Whether they be at the fda or the nih for the cdc so that we can in fact begin. Planning not just for what's happening now but well after january and so this is a very important development and one that will really help us a lot with the vaccine delivery to the united states. Is it a strange feeling that you're some total efforts are the hit the ground running january twentieth and in some cases you're inheriting wheels. That aren't moving. You're inheriting at administration without as we have this conversation a national plan. Well you know. I think it's really important to remember. We do have a number of really highly talented and skilled scientists within the federal government. I mean tony cheese. A classic example there are many outstanding individuals at the cdc in the fda that have had many many years of career service and really outstanding science development and research and so the fact says that they will still be part of this team. going forward. and i know that The biden harris administration will use that scientific expertise immediately. in addition. is you know the incoming administration is already starting to develop their own plants Whether it be around vaccination testing et cetera. So i think it it will be a good hand off that will occur and i'm excited about the fact that we now collectively all of us can really work together with science as the basic of value that. We're all using to judge what we do. So i think the next several weeks will actually be very positive in terms of what we can do to to move. This administered new administration forward. So that on january twentieth. It does hit the ground running. We have a graphic showing the air traffic currently over the united states. Every icon is an aircraft with people on board all those people leaving somewhere to go visit somewhere to then return home. Is it now predicted in your line of work because of all these people getting together. Despite all the government warnings that we're going to see a bump in hospitalizations and the death toll just in time for christmas. You know brian. This is one of the really sad commentaries about where we're at right now is helping america's understand the seriousness of the situation tonight as we said here we have over. Eight hundred thousand americans hospitals around the country with covid nineteen infections. Many of them critically. Ill are hospitals. Are breaking at the seams right now and so. It's really important that people understand. No one is asking them to sacrifice or to reduce their contact with others. Just for the sake of this is really about human life. it's about maintaining our healthcare systems. So yeah this is a real challenge for us and as you've seen as you know having been on this show a number of times with you you've seen what's happened since labor day. We've gone from twenty six thousand cases a day reported to now we're averaging over one hundred and seventy thousand cases and before long will be well over two hundred thousand cases a day that is going to break our healthcare system so please america understand you know we gotta stop swapping air in. The way we do that is we. Don't do all this. Large crowd related activity. That travel is going to be a problem and I don't wanna see where we're going to be in four or five weeks. It scares me a great deal. Dr michael oester home. Our thanks as always for joining us tonight. Greatly appreciate it. Good luck with your work upcoming
US to start distributing experimental virus drug
"It's just been approved for emergency usage by the FDA now the government shipping an experimental drug the second anybody treatment for coronavirus patience health and Human Services secretary Alex a stark says the government will start distributing doses of an experimental anybody drug to fight Kobe nineteen it's the same one president trump received last month we expect to distribute about thirty thousand doses of the Regeneron product tomorrow with more to come in the ensuing weeks it's given as a one time IV treatment a coronavirus patients who are at high risk of developing serious illness Dr Janet woodcock and FDA adviser to operation warp speed says studies suggest the drug can reduce the pressure on hospital systems CBOE high risk patient had a nine percent chance of hospitalization or even death that persists three percent of treated individuals earlier this month the FDA allowed similar use of drug from Eli Lilly Jennifer king Washington
AstraZeneca-Oxford Vaccine Up to 90% Effective in Trials
"AstraZeneca today became the third major drug company to report successful results for its potential covert 19 vaccine, joining Fizer and Moderna chief Executive Officer Pascal Story. Oh says this is ground breaking with the vaccine shown to be 90%, effective importantly, No Syria cases were seen and no hospitalizations, so it's a very, very attractive vaccine to Missy. Previously, Fizer and Madonna said their vaccines were shown to be almost 95%, effective in in clinical clinical trials trials and and FDA FDA committee committee is is scheduled scheduled to to meet meet December. December. 10 10 to to consider consider fighters fighters request request for for emergency emergency use use authorization authorization officials officials say say vaccinations vaccinations could could get underway.
Texas among states chosen to test COVID-19 vaccine distribution
"For the corona virus is imminent. Boxes. Charles Watson reports, the country is approaching an average of 200,000 new infections a day as the U. S. Adds 1.2 million Mork cases in the last week alone, what help could be on the way soon as Fizer awaits emergency approval from the FDA, Ford's Cove in 19 vaccine officials are preparing for an almost immediate roll out. The White House task Force said the U. S will ship millions of doses of the vaccine within 24 hours if the FDA grants emergency use Authorization. Healthcare workers. Nursing homes in those with serious medical conditions are expected to be among the first to receive the vaccine. The biotech company Moderna is another front runner to produce an effective vaccine and said it is also expected to apply soon for FDA emergency authorization for Houston area hospitals are working to prepare for shipments of the first one likely in mid December, the hospitals or Texas Children's Houston Methodist Memorial, Hermann and MD. Anderson Cancer Center. Advising the vaccines be given to frontline hospital workers First
Bill Gates, the Virus and the Quest to Vaccinate the World
"Who gates welcome back to the daily social distancing. Show good to see you you lost. Join us on the show. I would say it was about seven months ago and seven months ago. Just like dr fauci. You said you will worried because you felt like the worst was yet to come a lot of people accused you of peddling fear and terror and now it appears that unfortunately you were correct. Here's my question to you. Why does it seem like we've become worse at handling the pandemic you know in europe in the us then we were seven months ago when seven months ago. It was so bad. Well there's a couple of things working against us. I is that with the winter when we're colder we. The virus multiplies more and more indoors. More so that is not a good thing and then there's a certain fatigue. Some of the things people have had to do in terms of staying away from friends. That's tougher i've to say this round. It looks like europe is getting better compliance with the restrictions than the. Us is so they're starting to see a downturn. When you talk about that compliance and when you talk about the downturn is part of the downturn like should we should we be looking at the virus cases or should we be looking at the deaths because i never know which one is more important than usual. Be like a million more people to me. Five million seven million and then you'll see some doctors saying yes but fewer people are dying from because we know how to treat it. How should we be looking at this virus and the fight that we have against. It's well the case is our leading indicator it is true that cases are translating into less doubts for two reasons. One is that the cases are more in the young people Who are less likely to be very sick. And the other is that the quality of treatment including some new drugs like decks method have been proven out so when you do get hospitalized you have a higher chance of survival but were predicted to go back to over two thousand deaths a day in the months ahead so for the next six to eight months news is mostly bad after that the volume of the vaccine will have kicked in and then we'll have a light at the end of the tunnel. Wow i mean the the question is then i think for a lot of people is like. How long tunnel. How bad does that tunnel get. And how do we stop it from being the worst possible tunnel one of the big things. A lot of people are worried about is going to be the transition between joe biden. donald trump. You know you've worked with governments all over the world working on their vaccine distribution working on healthcare around the planet. You know how important it is for one administration to talk to the next when it comes to Handing off on their plans. How much do you think this will actually affect america's response if if there isn't a transition well it's unfortunate that the current administration got tied into a positive narrative that you know we're turning the corner And that you now have this transition will make. The message is a little less clear. You know this is when you'd love to see the best. Cdc people on tv reminding us about social distancing and masks. You know particularly when there is that fatigue out there so leaders at all level. This is a chance to step up even on politicians. You know encouraging friends that hey we. We don't want this additional several hundred thousand deaths you know it'd be adjective. A person who dies know when the vaccine is absolutely on the way and so i think the good news should drive compliance not lacks laxity as somebody who's done work globally around healthcare for so long especially around infectious diseases. What have you found is the key to encouraging or convincing community members to buy into the measures that keep them safe where we had vaccine resistance with polio and they're getting the religious leaders to speak out have them a visibly vaccinating their own children for would like we'd never stopped polio in africa and yet now it's just been certified that we've gone three years without wild polio so activating the trust hierarchy and getting rid of the conspiracy political element to it and just reminding people you know in this case. It's about saving lives in that case it's about kids not being paralyzed people back to that. Very human impact. If we don't behave well. I think it will often come through. It's interesting that you bring up conspiracies because the conspiracy theories about you online have are insane on social media and social media has propagates them in a way where it's like bill gates is trying to create vaccines so that he can cook troll your minds and he wants to vaccinate. Everybody can implant change. People's dna is what they said. You're going to change our dna. So that i don't know we turn into something and then we work for you somewhere. I don't know the full story. I'm still learning it when you see these things first of all. Have you been able to track down where it comes from. And secondly have you. Even i know you think about these things you want to like the biggest thing because i hadn't even thought about like the motivation behind it because i'm always trying to figure out who benefits from a conspiracy theory and i'd love to know if you've put any thought to this at all because of how many people won't get a vaccine because they truly believe conspiracy theories yeah usually when you work on infectious disease like dr fauci and high do your your kind of obscure in a nobody talks about t be or or malaria so here we have this complete turnaround where vaccines and are they. Good for people are now front and center. And there's always been a small group of anti vaccination people and we see this with you know measles vaccine. They've now got a platform and they've sort of joined forces with some political and spiracy abuse and it's so easy to click on particularly when a simple explanation for this pandemic that there is somebody evil behind it. You know as somehow easier than you know the true biology which is actually kind of complicated so we have to make the truth more interesting. And you know we've got a label things with the truth and sadly the naievety about how to make social media work. Well is pretty strong. And that's coincided with the election and the epidemic. I wish i had the answer. But you know it's it's it's out there in big big numbers and hasn't it just keeps growing so when we look at the vaccine. Now i mean that's now the story you know. Now the world is waiting for the vaccine because the vaccine becomes the key that unlocks the doors. You say the lights at the end of the tunnel. The question then is how do people get the vaccine. How effective will the distribution method be and how difficult is will the vaccine short supply. The good news is that there's four other vaccines that are likely to get approved fairly quickly as well. The fact that pfizer worked so well makes us optimistic. That astrazeneca johnson and johnson vacs which those are much cheaper easier to scale and don't require that cold chain so we'll have a lot of scenes and we need to prioritize people. At risk elder people people working nursing homes and each country Will have to decide okay. Who goes first. That's still a little bit confused in the us but hopefully we'll get that straightened out very very soon because the vaccine is likely to be shipped a lot in the month of december as you said anti vaccine community has only grown over time. I think the us is now the biggest hub of anti vexes in the world it started as a fringe thing with measles now with corona it is fully fledged and because of politics it's been amplified so now you'll have some people who on the liberal side saying i don't trust that vaccine it was made under trump and then you'll have other people saying like i don't trust that vaccine that came from joe biden and the and the democrats trying to brainwash. It's a lot of people may not want to take the vaccine which may now go against everything we've worked toward. So how do you begin convincing people that the vaccine is safe like in the midst of this political crisis. Well it's clear that the fda through the professional staff. They're all the things that are supposed to do likewise pfizer. There's even an external committee that will weigh in just to make absolutely sure that the the political desire to get this quickly did not in fact the efficacy and safety review and i feel very confident because the people involved are are really doing their job. Well we don't need everyone to take the vaccine. Society will have to decide if there's some jobs like going to a nursing home in taking care of somebody's grandparents whether that person you know how strongly you encourage them to have a vaccine so they're not spreading seeing but with this level of efficacy if we can get to seventy five percent dosed then you'll block the spread of the disease with measles you'd have to get to like ninety five percent because it's even more infectious but the good news here is that we just need that maturity and i think as people see people taking the vaccine and they see that The side effects of any are very very rare. That confidence will build and that will be good for society because when you take the vaccine you're helping to protect other people.
FDA Authorizes Regeneron's Covid-19 Antibody Cocktail Drug
"As pharmaceutical giant. Fizer asks for quick emergency approval to start shipping its covert 19 vaccine. The Food and Drug Administration is authorizing the emergency use of a second anybody drug to fight the virus, Regeneron's to drug cocktail That was given to President Trump when he had the virus as we build our medications to treat the virus, it's certainly encouraging, but the real hope is the vaccines that should be reviewed by the FDA in the near term, and hopefully we're available before year's end in the
The Latest: First US immunizations could arrive on Dec. 12
"The head of the US effort to produce a corona virus vaccine says the first immunizations could happen in less than three weeks speaking on ABC's this week Dr Monsef salary the chief scientific adviser for operation warp speed says the food and drug administration committee is set to meet on December tenth two consider Pfizer's request for emergency use authorization for its cold mid nineteen vaccine we are ready to start shipping vaccines within twenty four hours from approval Sally expects vaccinations would begin on December twelfth the second day after approval he says mo journey is expected to file for approval of its vaccine by the end of this month the FDA would then meet on December seventeenth two considered that request my camp in Washington
Trump administration ready to distribute Covid vaccines if approved, ‘Warp Speed’ advisor says
"Are more advances in the fight against Kobe 19. Saturday, the FDA granted emergency use authorization for Regeneron's antibody treatment. That's what President Trump received last month when he was sick, and the FDA also now considering emergency use authorization for five years vaccine. If that approvals given, Dr Monts Monts have have slowly slowly the the head head of of the the government's government's operation operation warp warp speed. speed. Tells Tells ABC ABC it it could could go go out out quickly. quickly. We We are are ready ready to to start start shipping shipping vaccines vaccines within within 24 24 hours hours from approval, he says. The vaccines are safe. He'd be happy to have his Children take 11 thing. He has not had any contact with the incoming bidet administration. It's incoming chief of staff, Ron Claims, says There's a lot of focus on that vaccine rollout plan that's gonna be critical in the early days. Of a buying president. So we have no access to that. That's because there's been no concession from President Trump's so the transition has not begun.
FDA allows emergency use of antibody drug Trump received
"The experimental coronavirus treatment President Trump received has gotten a green light from the Food and Drug Administration. The FDA has granted in emergency use authorization to bridge general on for its antibody drug that helps the immune system Fight Cove in 19. It's a second antibody drug to receive FDA emergency approval.
Regeneron antibody ‘cocktail’ wins emergency-use authorization from FDA
"Fda granting emergency authorization to the same experimental antibody cocktail that president trump credits with helping him recover from. The corona virus similar treatment manufactured by allied lilley was granted approval for emergency. Use earlier this
FDA Authorizes Regeneron's Covid-19 Antibody Cocktail Drug
"Coronavirus treatment President Trump received has gotten a green light from the Food and Drug Administration. The FDA has granted in emergency use authorization to Regeneron for its antibody drug that helps the immune system Fight Cove in 19. It's a second antibody drug to receive FDA emergency approval. The number of people who have contracted the Corona virus in the U. S now tops 12 million, and researchers at Johns Hopkins University say death total more than 255,000. Health officials urging Americans not to travel for Thanksgiving and
When will Pfizer’s coronavirus vaccine be ready to ship?
"Has authorized emergency use of a second antibody drug to fight covert 19. The FDA says the safety and effectiveness of Regeneron's to drug cocktail is still being evaluated, but it has shown to reduce hospitals hospitalizations for patients at high risk. CBS News Medical contributor. Dr David Egas says this, along with recent headway on vaccines is promising. As we build our medications to treat the virus. It's certainly encouraging. The real hope is the vaccines that should be reviewed by the FDA in the near term, and hopefully we're available before year's end in the country. Regeneron Kaka was given to President Trump when he was being treated for Corona virus. The FDA is allowing the use of Regeneron adults and Children, 12 and over who weigh at least £88 and who are at high risk of severe illness from covert 19 because of age or some medical conditions.
FDA Authorizes Regeneron's Covid-19 Antibody Cocktail Drug
"Company Pfizer is asking for quick emergency approval to start shipping its covert 19 vaccine. As the Food and Drug Administration authorizes the emergency use of a second antibody drug Regeneron's to drug cocktail that was given to Mr Trump when he had the virus,
Pfizer, BioNTech seek emergency use of COVID-19 shots in US
"Vaccine appears to be getting closer. I am sound. She ingress oh fox news. A promising update the potential vaccine produced by pfizer. The fda scientific advisors will have a public meeting on december tenth to review visors request for emergency use of their vaccine visor. Ceo says in addition to seeking approval from the fda. The company has initiated rolling applications to other regulatory authorities around the world we were already underway to make sure we can begin immediately through also company exacts for maderas say their vaccine is ninety four point five percent effective against covid nineteen plan to request emergency use for their vaccine from the fda and the coming
"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 KYW Newsradio 1060
"Facing FDA during the Copa nineteen pandemic is how do we sure the timely review of medical product applications despite an incredible surge in volume and constraints on our ability to construct in cycles factions I am pleased to announce today that FDA has maintained the same pace of meeting its goals on applications for medical products for the last six months that has maintained in recent years we are on target to meet our user fee goals for the drugs this year by reviewing and taking timely action on at least ninety percent of brand generic and biosimilar drug applications even during the pandemic additionally this work has continued at a time when the number of applications received in some centres is substantially higher than the pre covert nineteen times I want to thank the more than seventeen thousand please of tea at the FDA for their incredible efforts one that reflects the remarkable dedication and commitment to the public health of all Americans finally I'd like to discuss with us top of mind for all Americans namely the worked FDA's doing to facilitate the development of safe vaccines and therapeutics FDA launched emergency review and development program called the corona virus treatment accelerated program or C. tap and we continue to work night and day to provide guidance and to review proposals from companies scientists and researchers who are developing therapies let me be clear the data in science will dictate when we'll have safe and effective treatments and vaccines for covert nineteen as doctor felt you just mentioned toward that end FDA's using every available authority and applying every appropriate regulatory flexibility to facilitate development and testing we have not lost sight of our solemn.
"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 The Jason Stapleton Program
"Can help to cure and actually prevent a lot of very serious diseases in this country and so he said and the fda is committed to this kind of careful scientific research and drug development now this is the important part the reason i read this to you is because of what i'm gonna tell you next it says before they can start marketing the drug though the drug enforcement administration will have to reclassify cbd which in this case because it comes from marijuana is considered a schedule one drug meaning it has no medical value and a higher risk of abuse he say one of the reasons that marijuana continues to be illegal and we're having so much so many problems with it is that the da has classified this as a schedule one drug having no actual medical value at all and the fact that the fda just approved this drug proves that it does have medical value that in fact it has been known to to reduce seizures so while we may not see marijuana become legal or or they may not admit that it's now that you can now sell or distribute marijuana at a federal level what they are going to have to do is prove and say that cbd oil has actual value and let doctors administer cbd oil to their patients now this is a really good move why because once it becomes the drug becomes available for so for sale doctors can prescribe it for any number of what they call off label uses meaning just because a particular drug is designed to prevent seizures doesn't mean you can't give it to somebody for say they got a bad back and they got inflammation while normally you have to give them some sort of other drug to reduce the inflammation you'd have to give them some sort of that you got to cut this out of your diet or you gotta have tumor or something like that now they can prescribe cbd oil and you can go out and get cbd now if you live in california you're fine you can do that anytime you want to you can go buy you can buy marijuana anywhere you want to but this allows for the sale and distribution of a very powerful of a very powerful chemical that's going to help prevent a lot of disease help treat a lot of these all about prevent about prevention but will help treat a lot of diseases and very serious problems that americans have right now and i just nothing makes me happier this is a win because we have known for years years that cbd oil had very powerful very powerful healing effects and it's a natural drug doesn't there are to my knowledge there are no known side effects of utilizing negative side effects of using cbd can you imagine that i mean you watch these shows these commercials where they're talking about the drugs that that that you can buy and at the very end they're like oh don't use this if you if you've been if you would've don't use this if you have been prone to heart attack or it can cause either leading in anal fissures and you know instant death it can cause serious complications leading to heart stop it there's fifteen things they list off and the stuff that they're listing off is way worse way worse than whatever like skin rash you've got and so you think you so why on earth would i want to take a chemical like that but they sell that all day long and now here you have something that comes from nature that's extracted from a plant that has no no negative side effects to my knowledge some of you out there might know of something but certainly nothing even coming even close to the types of negative reactions that many drugs have and there are actually to my knowledge there are also no complications with other medications that you need to worry about so this is just all around a an exceptional oil for a lot of people to be using to cure like cirta to help with everything from like i said parkinson's disease and all the way to to what was being you for all.
"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
"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.