The Trump Administration Has Been Working With American Companies And Universities To Accelerate Coronavirus Related Applications Through The FDA
The Facts:
THE TRUMP ADMINISTRATION HAS MADE THE DEVELOPMENT OF VACCINES, TESTS, AND THERAPEUTIC TREATMENTS FOR THE CORONAVIRUS A NUMBER ONE PRIORITY
- On March 2, 2020, the President announced a new partnership with pharmaceutical and biotechnology companies in order to accelerate the development of vaccines and therapeutic treatments to combat the coronavirus.
- The agreement will ensure the development of vaccines and therapies moves forward " with maximum speeds ."
- Secretary of Health and Human Services Alex Azar has worked with pharmaceutical companies and the coronavirus task force to remove obstacles, address supply chain challenges, and speed up the research and development process.
- The Trump administration has " slashed red tape " in order to speed up the development of vaccines and therapies.
- The Food and Drug Administration (FDA) announced a new program, called the Coronavirus Treatment Acceleration Program (CTAP), which is allowing the FDA to use every tool to bring new therapies to sick patients " as quickly as possible ."
- The FDA has the ability to respond to requests from companies developing coronavirus treatments within 24 hours ; the agency explained that it's goal is "to get the right FDA staff in touch with them and work to get studies going fast."
- Additionally, the FDA is "reviewing expanded access request within three hours ."
THE FDA'S NEW PROGRAM IS BEING PUT INTO ACTION AND TESTING AND TREATMENTS ARE BECOMING AVAILABLE TO THE PUBLIC
- Due to the FDA's new program, there are 10 therapeutic agents in active trials and 15 more in planning stages.
- Dr. Stephen Hahn, the head of the FDA, said the agency is moving aggressively with testing therapies and treatments for the coronavirus.
- Hahn explained that the FDA is streamlining all processes to ensure that the FDA can get applications into the "treatment arena" and to the "hospitals as quickly as possible."
- On March 24, 2020, Governor Andrew Cuomo announced that New York will start using potential treatments , thanks to accelerated approval from President Trump and the FDA.
- U.S. health officials have been working with the biotech company Moderna to develop a vaccine, which began human trials on March 16 .
- In response to the first human trial, Dr. Fauci praised the process as a " record pace."
- Due to the FDA's emergency use authorization, rapid five minute point of care coronavirus testing will be coming to urgent care clinics .
- The new testing will be run on an ID NOW platform, which is the " most widely available molecular point of care testing platform in the nation."
- On April 6, 2020, the Department of Health and Human Services announced that ID Now COVID-19 tests and devices will become available for public health labs in every state and territory .
- Dr. Deborah Birx, the Coronavirus Task Force Coordinator, said that the administration is also working with universities and private companies to develop rapid coronavirus antibodies testing.
- The testing will help health care workers " peace of mind " by determining if they have the antibody; with the antibody, there is 99.9% chance of not being reinjected.
- On April 2, 2020, the FDA approved the first coronavirus antibody testing in the United States.
- CNN's Dr. Gupta: FDA approval of COVID antibodies test is " a big deal."
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THE TRUMP ADMINISTRATION HAS BEEN WORKING TO ACCLERATE THE DEVELOPMENT OF VACCINES, TESTS, AND THERAPEUTIC TREATMENTS
The White House Task Force Has Been Working With Pharmaceutical Companies To Ensure There Are No Barriers While Developing Vaccines And Therapeutic Treatments To Combat The Coronavirus
On March 2, 2020, The President Announced A Partnership With Pharmaceutical And Biotechnology Companies To Accelerate The Development Of Vaccines And Therapeutic Treatments To Combat The Coronavirus . PRESIDENT DONALD TRUMP: "Well, thank you very much. Today, we are meeting with the pharmaceutical and biotechnology companies - the biggest in the world, most prestigious, the ones that get down to the bottom line very quickly - to discuss how the federal government can accelerate the development of vaccines and therapeutic treatments for the coronavirus." ( The White House , 3/2/20)
The Trump Administration Agreed To Ensure The Development Of Vaccines And Therapies Move Forward "With Maximum Speeds." TRUMP: "We work to - we're working very hard to expedite the longer process of developing a vaccine. We're also moving with maximum speed to develop therapies so that we can help people recover as quickly as possible. We have a lot of recovery going on. We want to see if we can advance that. It's likely that therapies will be available before a vaccine is actually ready, and we'll seek to bring all effective treatments to market as soon as possible." ( The White House , 3/2/20)
Sec. Azar Said He Made Sure To Identify What Issues Pharmaceutical Companies Face By Asking How The Administration Can Speed Up The Process And Help With Supply Chain Challenges. SEC. AZAR: "We're here working with the pharmaceutical company leaders on three key issues: how do we speed vaccines, how do we speed therapeutics, and what are the supply chain challenges that we may be facing for pharmaceutical products here in the United States." ( The White House , 3/2/20)
In An Effort To Develop Vaccines And Therapies Quickly, The Trump Administration "Slashed Red Tape" To Speed Up Coronavirus Applications
The Trump Administration Has "Slashed Red Tape" In Order To Speed Up The Development Of Vaccines And Therapies . PRESIDENT TRUMP: "Today, I want to share with you exciting progress that the FDA is making with the private sector as we slash red tape like nobody has ever done it before. Somebody was on yesterday, on one of the networks, and said that there's never been a President even close that's been able to do what I've done in slashing all of the red tape and everything to get very important things to the market - medical. So we slashed red tape to develop vaccines and therapies as fast as it can possibly be done - long before anybody else was even thinking about doing this. And, as you know, earlier this week, we began the first clinical trial of a vaccine candidate for the virus, and that was launched in record time." ( The White House , 3/19/20)
The Food And Drug Administration (FDA) Has Announced A New Program, The Coronavirus Treatment Acceleration Program (CTAP), Which Is Allowing The FDA To Use Every Tool It Can To Bring New Therapies To Sick Patients "As Quickly As Possible." "Also on Wednesday, the FDA announced a new program geared at expediting the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while also supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this new virus." ( Fox News , 4/2/20)
· The FDA Has The Ability To Respond To Requests From People Developing Coronavirus Treatment Within 24 Hours, And The Agency Explained That It's Goal Is "To Get The Right FDA Staff In Touch With Them And The Work To Get Studies Going Fast." "In explaining the effects of CTAP, the FDA highlighted its ability to respond to requests from people developing COVID-19 candidates within 24 hours. The agency's goal is to get 'the right FDA staff in touch with them and the work to get studies going fast.'" ( Fierce Biotech , 4/1/20)
- The FDA Is Also "Reviewing Expanded Access Request Within Three Hours." "The Coronavirus Treatment Acceleration Program is designed to bring new therapies to COVID-19 patients as quickly as possible while supporting research to determine whether those therapies are safe and effective. The agency said that it was reviewing study protocols within 24 hours in many cases and reviewing expanded access requests within three hours." ( Modern Healthcare , 4/2/20)
THANKS TO THE TRUMP ADMINISTRATION'S POLICIES, CORONAVIRUS TESTING AND TREATMENTS ARE BEING ROLLED OUT TO THE PUBLIC
As The FDA's Accelerated Process Has Found Results, The Public Now Has Access To Treatments
Due To The FDA's New Program, There Are Now 10 Therapeutic Agents In Active Trials And 15 More In Planning Stages. "According to the agency, its efforts to expedite have led to there being 10 therapeutic agents in active trials and 15 more in planning stages." ( JDSUPRA , 4/6/20)
Dr. Stephen Hahn, Head Of The FDA, Said That The Agency Is Moving Aggressively With Testing Therapies And Treatments For The Coronavirus. "Dr. Stephen Hahn, the head of the Food and Drug Administration (FDA), said the agency is pushing forward 'very aggressively' with the testing of potential therapies and treatments for the novel coronavirus." ( Fox News , 4/2/20)
- Hahn Explained That The FDA Is Streamlining All Processes To Ensure That The FDA Can Get Applications Into The "Treatment Arena" And To The "Hospitals As Quickly As Possible." "Hahn added, 'We're streamlining all processes to make sure that we can get the applications that come to us into the treatment arena and the hospitals as quickly as possible.'" ( Fox News , 4/2/20)
- After The FDA Approved An Experimental Treatment, Researchers Now Have The Option To Request To Test The Procedure On Coronavirus Patients. "Experimental treatment of coronavirus patients with plasma from recovered patients has begun in New York and Houston after the Food and Drug Administration (FDA) approved such efforts. The effectiveness of the treatment is unknown, but the FDA approved it as a treatment on March 24, giving researchers the option to request emergency authorization to test the procedure." ( The Hill , 4/2/20)
- On March 24, 2020, Governor Andrew Cuomo, Announced That New York Will Start Using Potential Treatments, Thanks To Accelerated Approval From Trump, FDA. GOV. ANDREW CUOMO: "So in many ways, we have exhausted every option available to us. We've closed all the businesses, we've reduced the street density and we've increased testing to the highest level in the country we're also trying all the new drug therapies, the hydroxychloroquine which the President speaks about and is optimistic about and we hope for optimistic results also. We're actually starting that today, the President and the FDA accelerated that drug coming to New York, so the hospitals will start using that drug today. The FDA also authorized an experimental procedure by the New York State Department of Health where the Department of Health actually takes plasma from people who are infected, who have the antibodies, and will try putting that plasma into a person that is still struggling with the disease, hoping that the antibodies make a difference." (CNN Newsroom, 3/24/20)
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U.S. Health Officials Have Been Working With The Biotech Company Moderna To Develop A Vaccine, Which Began Human Trials On March 16. "U.S. health officials have been fast-tracking work with biotech company Moderna to develop a vaccine to prevent COVID-19. They began their first human trials on a potential vaccine March 16." ( CNBC , 4/1/20)
- In Response To The First Human Trial, Dr. Fauci Praised The Process As A "Record Pace." REPORTER: "Can I get Dr. Fauci to talk about the vaccine file today and whether the timetable for vaccine, is it possible to accelerate it, is it still 12 to 18 months?" DR. FACUI: "Thank you for the question, the vaccine candidate that was given the first injections to the first person took place today. You might recall when we first started I said it would be two to three months, and if we did that, that would be the fastest we're ever gone from obtaining the sequence to being able to do a phase 1 trial. This has been now 65 days, which I believe is the record. What it is, it's a trial of 45 normal individuals between the ages of 18 and 55. The trial is taking place in Seattle, there will be two injections, one at zero day, first one, then 28 days, there will be three separate doses 25 milligrams, 100 milligrams, 250 milligrams, and the individuals will be followed for one year, both for safety and whether it induces the kind of response that we predict would be protective, and that's exactly what I've been telling this group over and over again. so it's happened, the first injection was today." (CNN Newsroom, 3/16/20)
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Due To The FDA's Action, Rapid Point Of Care Coronavirus Testing Is Now Available For Every State And Territory In The United States
Due To The FDA's Emergency Use Authorization, Rapid Five Minute, Point Of Care Coronavirus Testing Will Be Coming To Urgent Care Clinics. "A five-minute, point-of-care coronavirus test could be coming to urgent care clinics next week, and experts say it could be 'game-changing.' The U.S. Food and Drug Administration issued Emergency Use Authorization to Illinois-based medical device maker Abbott Labs on Friday for a coronavirus test that delivers positive results in as little as five minutes and negative results in 13 minutes, the company said. The company expects the tests to be available next week and expects to ramp up manufacturing to deliver 50,000 tests per day." ( USA Today , 3/28/20)
- The New Testing Will Be Run On An ID Now Platform, Which Is The "Most Widely Available Molecular Point Of Care Testing Platform In The Nation." "The test runs on the company's ID NOW platform, a 6.6-pound portable device the size of a small toaster. There are currently about 18,000 ID NOW instruments in the U.S. - the most widely available molecular point-of-care testing platform in the nation, Frels said. Unlike high-throughput batch testing platforms that can run hundreds of tests at a time but take several hours, the ID NOW platform is a bench-top instrument used at physician offices and urgent care clinics. The platform is typically used to run tests for other respiratory illnesses, such as the flu, strep and RSV - and similarly uses samples from throat and nose swabs." ( USA Today , 3/28/20)
On April 6, 2020, The Department Of Health And Human Services Announced That ID NOW COVID-19 Tests And Devices Will Become Available For Public Health Labs In Every State And Territory. "HHS is providing these tests and devices to public health labs (PHLs) in every state and territory, and Washington, D.C. To ensure that remote and rural populations are also being reached, the Indian Health Service will receive tests and devices to distribute to selected IHS and tribal locations. Additionally, HHS is procuring ID NOW COVID-19 tests and devices for the Strategic National Stockpile (SNS). Abbott is producing 50,000 ID NOW COVID-19 rapid point-of-care tests per day to supply the commercial market. The International Reagent Resource exit disclaimer icon (IRR), operated by the Centers for Disease Control and Prevention, will procure additional tests each week to support requests from PHLs. The test devices will begin arriving at PHLs as early as Monday, April 6. Test resupply for the state health labs will be routed through the IRR." ( Health And Human Services , 4/6/20)
After Partnering With Universities And Private Companies, The First Coronavirus Antibody Testing Was Approved By The FDA
Dr. Deborah Birx, The Coronavirus Task Force Coordinator, Said That The Administration Is Also Working With Universities And Private Companies To Develop Rapid Coronavirus Antibodies Testing. "Dr. Deborah Birx, the coronavirus task force coordinator, said she's been asking universities and private companies to develop rapid coronavirus tests to confirm whether health-care workers that have been treating coronavirus patients already have the antibodies to fight it." ( CNBC , 4/1/20)
The Testing Will Help Health Care Workers' "Peace Of Mind" That If They Have The Antibody, There Is 99.9% Chance Of Not Being Reinfected . "She said the U.S. owes it to health-care workers - many of whom have been treating coronavirus patients for a month now - 'the peace of mind that would come from knowing that you already were infected, you have the antibody, you're safe from reinfection 99.9% of the time.' She said U.S. universities can get those tests out by Friday." ( CNBC , 4/1/20)
On April 2, 2020, The FDA Approved The First Coronavirus Antibody Testing In The United States. "The Food and Drug Administration on Thursday approved a new test for coronavirus antibodies, the first for use in the United States. Currently available tests are designed to find fragments of viral genes indicating an ongoing infection. Doctors swab the nose and throat, and amplify any genetic material from the virus found there." ( The New York Times , 4/2/20)
- CNN's Dr Gupta: FDA Approval Of COVID Antibodies Test Is "A Big Deal." KATE BOLDUAN: "The FDA announced they are authorizing the first antibody test. When it comes to the coronavirus, this is of course different from testing for the virus. This is testing for antibodies that would be in your system, what does that mean and how important is this?" DR. SANJAY GUPTA: "Well, I think first of all, you have good medical knowledge and you come from a medical family, you described it well. This is a test sort of looks for not the virus and not active infection but indicated that you were exposed and your body reacted for the virus. It is a strip and it has some virus on it, you take someone's plasma and you add it to the strip. It will react to the virus and changes color, you know at that point that you have antibodies and there are ways to tell how significant and how many antibodies and what percentage of antibodies you have. It is a really good test, your question is, is this a big deal? Yes, people want to know have I been exposed and not known it, a lot of people don't develop symptoms. If I have been exposed and my antibodies come back positive, do I have some degree of confidence that I am protective. We talked about sending people back to work and talking about doing it geographically. That makes sense thinking of people being protected going back to work." BOULDUAN: "This is the kind of test and you can do it in so many other things and HIV and they can get it going on Friday. It is not a tough thing to do, we can all say let's do it." (CNN's "Kate Bolduan," 4/2/20)
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