Failure of ALS drug puts a spotlight on controversial FDA approvals

Washington Post, March 16, 2024: New study results showing that the ALS drug Relyvrio does not work raises important questions about FDA’s decision to be flexible about approval even when the scientific evidence is lacking. We explain that the pendulum has swung too far and each questionable approval results in more pressure on FDA to make more questionable approvals.

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Why journalists should scrutinize the FDA’s accelerated drug approval process

March 7, 2024 article by Association of Health Care Journalists explains the problems with the FDA accelerated approval process and gives advice on how to cover the evidence accurately. NCHR’s Diana Zuckerman explains that when FDA rescinded approval of the cancer drug Pepaxto, it was an easy call because the company took it off the market 2 years ago because of the higher death rate in a clinical trial.

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