BIDEN ADMIN/CORONAVIRUS/FDA/VACCINES: “The Biden Administration did a terrible disservice to people throughout the world by allowing the FDA and CDC to call a ‘pause’ in the use of the Johnson & Johnson COVID-19 vaccine. The results of this vaccine have been extraordinary but now it’s [sic] reputation will be permanently challenged. The people who have […]

Read More… from 4/13/2021


BIDEN-HARRIS ADMIN/CDC/FDA/JOE BIDEN/NIH: “Our Administration will lead with science and scientists — with a CDC and NIH that are free from political influence, a Surgeon General who is independent and speaks directly to the people, and an FDA whose decisions are based on science and science alone.” ––Joe Biden, Twitter.com, January 18, 2021 7:02 am […]

Read More… from 1/18/2021


CORONAVIRUS/SCOTT GOTTLIEB/TRUMP ADMIN/VACCINES: “Former Food and Drug Administration Commissioner Dr. Scott Gottlieb, now on the board of Pfizer, said that the United States was offered more of the company’s successful coronavirus vaccine as recently as November — but didn’t take the deal… Gottlieb, who was Trump’s FDA chief until April 2019, noted that the U.S. […]

Read More… from 12/14/2020


CORONAVIRUS/FDA/VACCINES: “I have really good news. Today, our nation has achieved a medical miracle. We have delivered a safe and effective [coronavirus] vaccine in just nine months. This is one of the greatest scientific accomplishments in history. It will save millions of lives, and soon end the pandemic once and for all. I am thrilled […]

Read More… from 12/11/2020


CORONAVIRUS/COVID-19/FDA/VACCINES: “While my pushing the money drenched but heavily bureaucratic @US_FDA saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!“ ––Donald Trump, Twitter.com, December 11, 2020 1:11 am […]

Read More… from 12/11/2020


CORONAVIRUS/COVID-19/FDA/JOE BIDEN/MEDIA/VACCINES: “Yesterday marked another tragic, preventable milestone in our fight against COVID-19, but this news is a bright light. I’m grateful for every scientist, researcher, and public health expert who made it possible. RT @nytimes Pfizer’s Covid-19 vaccine received a vote of confidence from FDA advisers, clearing the way for the agency to authorize […]

Read More… from 12/10/2020


CORONAVIRUS/FDA/VACCINES: “We’re very hopeful that the FDA will authorize the Pfizer [coronavirus] vaccine within days. We got to get it moving. And Moderna vaccine almost immediately thereafter. Large numbers of tests and samples have been done, so hopefully that’ll go very quickly. If authorized, tens of millions of vaccine doses will be available this month. […]

Read More… from 12/8/2020


CORONAVIRUS/COVID-19/FDA/MEDIA/PHARMA/QUOTE/TRUMP AS PRESIDENT/VACCINES: “‘President Trump told us for some time we would be getting a Vaccine by the end of the year and people laughed at him, and here we are with Pfizer getting FDA approval by the end of this month. He was right.’ @MariaBartiromo“ ––Donald Trump, Twitter.com, November 10, 2020 2:01 am […]

Read More… from 11/10/2020


2020 ELECTION/CORONAVIRUS/COVID-19/FDA/PHARMA/VACCINES: “As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!“ ––Donald Trump, Twitter.com, November 9, 2020 1:40 pm […]

Read More… from 11/9/2020


CORONAVIRUS/FDA: “The [coronavirus] medications that I took were standard, pretty much routine, other than the one, which is a miracle. It’s the antibody stuff, which is incredible, how it works. And we’re going to be delivering that to hospitals. We’re waiting for the emergency use authorization… And I got the FDA to approve things at […]

Read More… from 10/11/2020


CORONAVIRUS/COVID-19/FDA/NEW YORK/SENIORS/VACCINES: “Governor Andrew Cuomo of New York wants to put New York at the END of the Vaccine List in that he doesn’t trust the @FDA or Federal Government, even though the Vaccines are being developed by the finest Labs in the World. Wish he trusted us on Nursing Homes!“ ––Donald Trump, Twitter.com, September […]

Read More… from 9/25/2020


CORONAVIRUS/COVID-19/FDA/VACCINES: “Big news. Numerous great companies are seeing fantastic results. @FDA must move quickly! RT @nytimes Johnson & Johnson has begun the final stage of clinical trials for its coronavirus vaccine. Unlike some of its competitors, the vaccine does not need to be frozen and may require just one shot instead of two.“ ––Donald Trump, […]

Read More… from 9/23/2020


FDA/JOE BIDEN/TRUMP ADMIN: “Did you ever seen any administration put so much pressure on the FDA?… I mean, there’s no bounds to what this guy [Donald Trump] does and his team does. We should listen to the scientists… What’s he doing?” -Joe Biden, “Andrew Mitchell Report,” MSNBC, Aug. 27, 2020 […]

Read More… from 8/27/2020


CORONAVIRUS/FDA/HHS/TRUMP AS PRESIDENT: “Health and Human Services Secretary Alex Azar pushed back Wednesday against claims that President Trump pressured the Food and Drug Administration (FDA) to authorize the use of convalescent plasma to treat coronavirus patients, but he did credit Trump for removing ‘unnecessary bureaucratic red tape that stands in the way of saving lives.’… […]

Read More… from 8/26/2020


CORONAVIRUS/COVID-19/FDA: “FDA Commissioner Dr. Stephen Hahn is walking back comments on the benefits of convalescent plasma, saying he could have done a better job of explaining the data on its effectiveness against the coronavirus after authorizing it for emergency use over the weekend… The FDA’s decision to authorize emergency use came a day after President […]

Read More… from 8/25/2020


CORONAVIRUS/FDA: [Tim Boyum: “Over the weekend, you criticized, sort of, the FDA, for potentially delaying whether it’s a [coronavirus] vaccine or therapeutic. Do we have evidence of that or is that a gut feeling that you have?”] “Well, I think there’s some evidence and I think it’s a big gut feeling, and in the meantime, […]

Read More… from 8/24/2020


COVID-19/FDA: [Reporter: “Convalescent plasma, as a treatment, has been around for, you know, over 100 years… What went into the effort for this to be approved for COVID-19? And was that holdup political in nature?”] “Well, I think that there might have been a holdup, but we broke the logjam over the last week, to […]

Read More… from 8/23/2020


CORONAVIRUS/COVID-19/FDA: “Many doctors and studies disagree with this! RT @TwitterMoments The FDA is revoking its emergency use authorization of hydroxychloroquine and chloroquine for treating COVID-19 amid growing evidence that the drugs are ‘unlikely to be effective’ in treating the coronavirus.“ ––Donald Trump, Twitter.com, August 22, 2020 2:26 am […]

Read More… from 8/22/2020


2020 ELECTION/CORONAVIRUS/COVID-19/FDA/PHARMA/VACCINES: “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA“ ––Donald Trump, Twitter.com, August 22, […]

Read More… from 8/22/2020


CORONAVIRUS/FDA: [Reporter: “Oleandrin — have you heard of that as a possible therapy for coronavirus?”] “I’ve heard of it, yes.” [Reporter: “Have you pressed the FDA to approve it?”] “No, I haven’t. I haven’t… Is it something that people are talking about very strongly? We’ll look at it. We’ll look it. We’re looking at a lot […]

Read More… from 8/17/2020


FDA/TRUMP AS PRESIDENT/VACCINES: “If you had another president other than me, you wouldn’t be talking [coronavirus] vaccines for two years, you know that. What I did with FDA has been amazing, according to everybody. Literally, it’s been amazing. And no, I’m pushing it very hard and I want to push it very hard, I will […]

Read More… from 8/6/2020


CORONAVIRUS/COVID-19/DEMS/FDA “The highly respected Henry Ford Health System just reported, based on a large sampling, that HYDROXYCHLOROQUINE cut the death rate in certain sick patients very significantly. The Dems disparaged it for political reasons (me!). Disgraceful. Act now @US_FDA @TuckerCarlson @FoxNews“ ––Donald Trump, Twitter.com, July 6, 2020 4:32 pm   […]

Read More… from 7/6/2020


CORONAVIRUS/COVID-19/FDA: “So with the hydroxychloroquine is something that I have been pushing very hard. I got the very early approval from the FDA. It was going to take a long time, and Dr. Stephen Hahn, the Head of the FDA, gave us an early approval, a very quick approval, a 24-hour approval. I mean, it […]

Read More… from 3/30/2020


FDA/OHIO/TRUMP AS PRESIDENT: “Thank you Dr. Hahn & the FDA for your fast approval of this respected Ohio company recommended by Governor @MikeDeWine. Great potential! https://t.co/jAiIUAXwaL“ –Donald Trump, Twitter.com, March 30, 2020 6:07 am […]

Read More… from 3/30/2020


CORONAVIRUS/FDA/OHIO/TRUMP AS PRESIDENT: “Hope the FDA can approve Mask Sterilization equipment ASAP. As per Governor @MikeDeWine, there is a company in Ohio, @Battelle, which has equipment that can sterilize masks quickly.” –Donald Trump, Twitter.com, March 29, 2020 11:12 am […]

Read More… from 3/29/2020


CORONAVIRUS/DRUGS/FDA/TRUMP AS PRESIDENT: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)…..” –Donald Trump, Twitter.com, March 21, 2020 9:13 am […]

Read More… from 3/21/2020


FDA/TOBACCO INDUSTRY/TRUMP AS PRESIDENT: “The Trump administration Thursday [1-2-20] rolled out a limited ban on flavored e-cigarettes, enraging anti-tobacco advocates who called the measure a political capitulation that would cause more kids to become addicted to nicotine. The new plan will bar the sale of all sweet and fruity flavored vape pods and cartridges within […]

Read More… from 1/2/2020


FDA/NOMINATIONS/TRUMP AS PRESIDENT: “President Donald Trump’s nominee for FDA commissioner declined at his confirmation hearing Wednesday [11-20-19] to promise to move forward with an e-cigarette flavor ban that the administration has put on hold…Hahn added that he was committed to ending vaping by teenagers. Trump in September announced his intention to ban flavored vapes including […]

Read More… from 11/20/2019


FDA/HHS/NOMINATIONS/TRUMP AS PRESIDENT/TRUMP PEOPLE: “President Trump said Friday [11-1-19] that he intended to nominate Dr. Stephen M. Hahn, a top executive at The University of Texas M.D. Anderson Cancer Center, to be the next commissioner of the Food and Drug Administration. If he is confirmed by the Senate, Dr. Hahn would fill the vacancy left […]

Read More… from 11/1/2019


CANADA/DRUGS/FDA/PHARMA/TRUMP AS PRESIDENT: “The Trump administration said on Wednesday [7-31-19] that it was taking steps to make it easier to import less expensive prescription drugs from other countries, particularly Canada. The move has long been supported by progressives but has encountered fierce opposition from the pharmaceutical industry. The proposal would permit pilot programs developed by […]

Read More… from 7/31/2019


FDA/TRUMP AS PRESIDENT: “Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month….” -Donald Trump, Twitter.com, March 5, 2019 3:54 pm […]

Read More… from 3/5/2019


DRUGS/FDA/TRUMP AS PRESIDENT: “President Donald Trump signed the ‘Right to Try Act’ Wednesday [5-30-18], a measure aimed at helping terminally ill patients access drug treatments that are yet to be fully approved by the Food and Drug Administration. Trump, at a White House ceremony surrounded by patients and families who will be affected by the […]

Read More… from 5/30/2018


CHINA/DRUGS/FDA/TARIFFS/TRUMP AS PRESIDENT: “The Trump administration’s proposed tariffs on thousands of Chinese-manufactured products would target dozens of key products used by drugmakers, as well as medical devices including pacemakers and artificial joints. The 25 percent tariff would be placed on raw ingredients for drugs such as insulin used by diabetics, the anti-allergic-reaction drug epinephrine, as […]

Read More… from 4/3/2018


FDA/SCOTT GOTTLIEB: “Federal health officials this week allowed a genetic testing firm to sell kits to consumers to test whether they carry gene mutations that put them at higher risk for breast and ovarian cancer. The action, part of a broader regulatory shift, is the first time the Food and Drug Administration has allowed a […]

Read More… from 3/9/2018


DRUGS/FDA/HHS/PHARMA/SCOTT GOTTLIEB: “Scrutiny of prescription drug prices isn’t going away, no matter how badly investors wish that it might. Scott Gottlieb, commissioner of the Food and Drug Administration, laid out the flaws in how drugs are priced in the U.S. in a speech on Wednesday [3-7-18] before a health-insurance trade group… Excessive market concentration among […]

Read More… from 3/7/2018


DRUGS/FDA/HHS/PHARMA: “In an effort to encourage new treatments for opioid addiction, the Food and Drug Administration plans to begin permitting pharmaceutical companies to sell medications that help temper cravings, even if they don’t fully stop addiction. The change is part of a wider effort to expand access to so-called medication-assisted treatment, or MAT. The agency […]

Read More… from 2/25/2018


DRUGS/FDA: “The Food and Drug Administration has approved the first blood test to evaluate concussions, otherwise known as mild traumatic brain injuries, in patients after accidents, military wounds, sports collisions and other causes. The blood test from Banyan Biomarkers Inc. could be useful in diagnosing brain injuries that lead to an estimated 2.5 million emergency-room […]

Read More… from 2/15/2018


FDA/TRUMP AS PRESIDENT: “President Donald Trump, in his State of the Union address, gave a boost to so-called Right to Try legislation that would give terminally-ill patients greater access to experimental drugs. Public-health advocates are pushing back, characterizing the Right to Try movement as a solution to a nonexistent problem. Right to Try laws, having […]

Read More… from 1/31/2018


FDA/HHS: “The Food and Drug Administration is not moving quickly enough to ensure that contaminated food is removed from store shelves, despite being given the necessary authority, federal investigators have concluded. The inspector general of the Department of Health and Human Services examined 30 of 1,557 food recalls between 2012 and 2015. The investigators found […]

Read More… from 12/27/2017


FDA/PHARMA/SCOTT GOTTLIEB: “The Food and Drug Administration plans to allow quick approval of some cancer drugs if they show early and ‘outsized’ survival benefits for patients even in small studies, the FDA’s commissioner said Thursday [11-30-17]. Scott Gottlieb told the House Energy and Commerce subcommittee on health that the agency expects to see this situation […]

Read More… from 11/30/2017


DEFENSE/FDA: “The Defense Department — and not FDA — would have the power to approve drugs and medical devices under the defense policy bill that’s being hammered out by a conference committee, alarming congressional staff and Health and Human Services officials who say it would undermine medical safety and potentially put soldiers at risk. Section […]

Read More… from 11/6/2017


DRUGS/FDA/HHS/SCOTT GOTTLIEB/TOM PRICE: “As the opioid epidemic in the U.S. continues to kill more and more Americans, the Food and Drug Administration wants to lift the stigma on the idea of using drugs to treat a drug habit. FDA Commissioner Scott Gottlieb told a U.S. House committee on Wednesday [10-25-17] that his agency is looking […]

Read More… from 10/25/2017


FDA/NOMINATIONS/SCOTT GOTTLIEB: “U.S. Food and Drug Administration Commissioner Scott Gottlieb, considered a potential successor to recently departed Health and Human Services Secretary Tom Price, said on Tuesday [10-10-17] he believed he could best serve the Trump administration in his current role… He declined to say whether he had been approached about the job by the […]

Read More… from 10/10/2017


DRUGS/FDA/SCOTT GOTTLIEB: “The new commissioner of the Food and Drug Administration declared high drug prices are ‘a public health concern that FDA should address,’ and he began offering concrete steps the agency will employ to speed new, complex drugs to market through more efficient processes partially designed to address high drug prices. Commissioner Scott Gottlieb […]

Read More… from 10/2/2017


FDA/TRADE DEALS/TRUMP AS PRESIDENT: “A Trump administration plan to shift work on international food safety issues to a trade office under the supervision of a former animal-drug company executive is sparking an outcry from internal and external critics who say the move signals the U.S. is more interested in promoting exports than in science-based public […]

Read More… from 10/2/2017


FDA: “The Food and Drug Administration is stepping up oversight of fledgling medical treatments that aim to harness the potential of stem cells—as well as some businesses that the agency said were selling unapproved and possibly harmful treatments. The FDA announced it was crafting rules to govern the development of treatments based on the cells. […]

Read More… from 8/28/2017

Posted in FDA


FDA/TRUMP AS PRESIDENT: “The Food and Drug Administration has received dozens of reports over a decade about hair-straightening treatments that contain the carcinogen formaldehyde and can sicken salon workers and customers with burning and blisters in the nose and throat, nausea, and flulike symptoms. Yet six years after a consumer-safety group petitioned the agency to […]

Read More… from 8/18/2017


DRUGS/FDA/TRUMP PEOPLE/SCOTT GOTTLIEB: “Food and Drug Administration Commissioner Scott Gottlieb is calling for his agency to institute rigorous new safety standards for how immediate-release opioids are prescribed, in an effort to curb the nation’s opioid crisis. Dr. Gottlieb, in a talk kicking off an FDA workshop of public-health officials on painkiller safety and abuse, said […]

Read More… from 7/10/2017


FDA/POLITICS: “U.S. Senate Republican Leader Mitch McConnell told Reuters on Wednesday [5-24-17] he expects bipartisan support for approval of a bill authorizing taxpayer and industry funding for the U.S. Food and Drug Administration. The bill to reauthorize the Prescription Drug User Fee Act would let the FDA continue to collect hundreds of millions of dollars […]

Read More… from 5/24/2017


FDA/TRUMP PEOPLE/SCOTT GOTTLIEB: “The U.S. Senate on Tuesday [5-9-17] voted 57-42, mostly along part lines, to confirm Scott Gottlieb as the new commissioner of the Food and Drug Administration. Dr. Gottlieb, a veteran health-care investor and physician, is well known to many drug-industry executives. He worked for years as a consultant to companies including GlaxoSmithKline […]

Read More… from 5/9/2017


CABINET/FDA/TRUMP PEOPLE/SCOTT GOTTLIEB: “The White House is expected as early as Friday to nominate Dr. Scott Gottlieb, a physician and conservative health policy expert, to lead the U.S. Food and Drug Administration, sources familiar with the matter said. If confirmed by the Senate, Gottlieb would be in charge of implementing President Donald Trump’s plan to […]

Read More… from 3/10/2017