What’s going on at the FDA? 10 agency updates

What’s going on at the FDA? 10 agency updates

https://www.beckershospitalreview.com/pharmacy/what-s-going-on-at-the-fda-10-agency-updates.html

The FDA is a government agency tasked with protecting public health by making sure prescription drugs are safe and efficient. 

In the last couple of months, several studies have been published questioning how the agency does its job, a new commissioner took over and the agency created a program to improve drug quality. 

Ten FDA updates reported by Becker’s Hospital Review since December: 

Editor’s note: This is not an exhaustive list. Events are listed in order from most to least recent. 

  1. FDA approvals relying on weaker evidence, study finds
    While the FDA has gotten faster at approving new drugs, it is relying on weaker evidence in granting those approvals.
  2. FDA warning letters to devicemakers down nearly 90 percent
    The number of warning letters the FDA sent to medical devicemakers fell by almost 90 percent between 2015 and 2019, and it could be because the FDA is too focused on pleasing the device industry.
  3. FDA, NIH allowed clinical trial sponsors to keep results secret
    Institutions that conduct clinical trials — such as pharmaceutical companies and universities —  do a poor job following a law that requires them to post clinical trial results on a government website, and the government agencies that are supposed to enforce that law are ignoring it.
  4. JAMA editorial blasts FDA’s reporting of medical device problems
    The FDA needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an editorial published in JAMA Internal Medicine.
  5. FDA rush to meet drug approval deadlines doubles adverse patient effects, study finds
    More drugs are approved in December than any other month, but end-of-year approvals are associated with twice the number of adverse effects, including hospitalizations and deaths.
  6. FDA creates Center of Excellence program to improve compounded drug quality
    The FDA formed the Compounding Quality Center of Excellence program to mitigate quality issues with compounded drugs.
  7. Senate confirms Dr. Stephen Hahn as FDA chief
    Stephen Hahn, MD, became the latest FDA commissioner after the Senate voted 72-18 to confirm him.
  8. Decline in number of FDA inspections raises concerns about safety of pharma supply chain
    The number of FDA inspections of drug manufacturing facilities has declined, partly because of a lack of inspectors, raising concerns about the safety of the global pharmaceutical supply chain.
  9. Rapid FDA drug approvals raise patient safety concerns
    The FDA has been approving new drugs so quickly that some patient safety advocates are voicing concerns.
  10. Serious drug side effects likely underreported to FDA, study finds
    Underreporting prescription drug side effects may be much more common than previously thought.

7 Responses

  1. They just want to kill Us Faster! That’s exactly what I’m seeing here. IF the older medications work, DONT Reinvent the Wheel. IF these New drugs aren’t coming from other countries that use them daily? Then what they’re passing through quickly is NOT safe! Beware of

  2. Today we are racing against time to determine how to find the original source of the coronavirus. Millions of dollars and directed research in university hospitals will focus on it throughout the world. This is acute care. It needs to be done.

    I have been a researcher in fisheries and wildlife. It gets little attention hpwever it is possible that the first cross over occurred at a market that sold more than lobster; wild animals were sold for food and with them likely the coronavirus. I studied beaver habitat and got giardia.

    The slow moving attitude towards figuring out our human bodies in connection with habitats leads to government regulation bodies that are at a loss. The FDA, CDC and their equivalents around the world need to broaden their scope and quickly share findings. It means that we will forge ahead with knowledge moving quickly into clinical practise.

    The meeting in Davos will I hope bring together health, climate change, economics and affect all whom attend. We must be central to any issues as true partners.

  3. Pretty scary! This is what happens when industry insiders and profiteers make sure the laws regulations are rendered meaningless. Reporting anything that could cut into corporate profits or make a corporation look bad, is just not allowed. The industry and their highly paid lobbyists and politicians, made sure that even CMS, or any other agency that was supposed to track outcomes or deaths, was unable to collect meaningful data. No medical or mass media news outlet covered that story, since they are all dependent on corporate or foundations dark money.

    This is called regulatory capture, the misinformation about the so called opioid epidemic should have been a wake-up call. Reframing the nations Epidemic of Despair for marketing purposes as Americans died, endured surgery without anesthetic, and low income and minority people were locked up, was a brilliant marketing and propaganda strategy.

    We are no longer a democracy, the corporations and banks have taken over. The FDA, CDC, NIH are all much too corrupt to function in any meaningful way. The FTC, totally under corporate control, allowed lies and false narratives that directly impacted our health, and led to deaths to be repeated by media. They failed to regulate any online advertising, as lies and marketing replaced facts.

    Our politicians are still after all of these years quibbling over “lowering prescription drug prices” compromising with the corrupt corporations, because they took money from the very same industry. They paid expert propagandists and marketers to place the blame on doctors, pharmacists, and patients, instead of the insurance industry, pharma, and the corporations running our federal agencies.

    They even re-framed pain and torture as something that can be ignored for the patients own good. This was while American patients died from lack of medical care, sepsis, the flu, and medieval diseases. They allowed quacks, frauds and grifters to write healthcare policy, and market unproven cures, while the dead went uncounted. Thousands of Americans will be hospitalized this year with the flu, and quite a few children will die, because there was a profit to be made.

    The mass media did not cover this topic as they allowed content marketers, industry insiders to direct the “news” they provided. Every news outlet depends on millions of dollars in ad revenue from the pharma industry. They are not going to jeopardize that with facts and meaningful reporting. The industries are still misleading us with nonsense about innovation, while the only innovation we have seen is in how they deceive the public, and increase their stock prices.

    We are witnessing the End of Democracy and the Truth!

    • That’s why it’s time to do what was just done in Virginia!!
      Time to march to DC and over throw the morons and take this country back. Nothing will come of talk protests etc If it’s not done soon we will totally lose this country!! It scared the idiots shitless in Virginia!!

      • They arrested Nazis and white supremacists that were inciting violence in Virginia. These are the same people protesting for less regulations, legal corruption, and more privatization at the FDA. A steady stream of lies and propaganda, is inciting hate, spreading misinformation and destroying what is left of our democracy.

        In Virginia, propagandists lied to gun owners, and told them the “government was taking their guns.” This was not factual, these lies were meant to incite violence. Nazis and white supremacists, with the help of right wing commentators, complicit police departments and mass media, tried to incite violence to keep people from understanding how corrupt corporations have been lying to them.

        The FDA has been systematically dismantled, by corporate funded politicians, corrupt lobbyists, and unlimited money in politics. These government agencies were supposed to protect public health, but now they only answer to the corporations. In order to hide the corruption, they had their propagandists, blame minorities,and liberals. It was more profitable to spread hate and violence and divide the country.

        The same things are going on at other federal agencies too. The FDA let Boeing do it’s own safety inspections, after corporate funded politicians, took funding away from key positions. The same at the Department of Agriculture, now meat producers can do their own inspections. People died when Boeing planes crashed, yet the corrupt administration did nothing. Rates of food poisoning and deaths from contaminated food are rising, but the corrupt administration is getting rid of more safeguards, that were meant to protect the American people.

        Some people are waking up to the fact that they were played, years of lies and propaganda in mainstream media, led to this. People are dying in horrific mass shootings so that the gun industry can sell more guns. This is not even about American gun ownership, it is about selling more guns to other nations, and inciting global violence. What we are seeing is the effect of corrupt, unregulated capitalism. Don’t get angry, just follow the money.

    • We are Republic last I checked..

      • The politicians are not listening. They’re dictating to us make us complying slaves to them! They have forgotten that the Houses, Capital and courts are “THE PEOPLE’S.” They forgot they WORK for Us not For Themselves or what They WANT.
        I Totally agree that Americans need to stick together, NOT allow the FAKE, Indoctrinating main stream media , The schools and Gov To continue DIVIDING US any longer! THIS is they’re PLAN. Divide us so We DO NOT Organize and that shouldn’t be all done on social media either. We need to go back using techniques our forefathers used before phones. Paul Revere used notes and lanterns. Our privacy has been so Infringed Upon, theyve stolen it. They’re constantly drilling away at Stealing our Liberty, Freedoms and God given Rights.
        I don’t believe Voting is going to get us out this mess. It’s Been Bought and Rigged. Sorry Folks. And NEVER give up your 2A. It designed to keep a Tyrannical Gov in line.

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