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

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.

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