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 NCHR’s Diana Zuckerman explains that when FDA rescinded approval of the cancer drug Pepaxto, it was an easy call because the company took it off the market 2 years ago because of the higher death rate in a clinical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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Accelerated Approval Withdrawal Offers Hints On New FDA Approach

Inside Health Policy, March 4, 2024: NCHR was interviewed regarding the FDA rescinding accelerated approval for Pepaxto for multiple myeloma. We explain that the FDA’s new “’streamlined’ path to reverse approval decisions still takes years even after there is proof that patients taking the drug are more likely to die.

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Medicare has different standards than the FDA. That’s how it should be

STAT News, February 2, 2024: NCHR’s Diana Zuckerman’s commentary in STAT News explains why Medicare should not pay for every medical product that FDA approves, since some are more likely to harm rather than help Medicare patients. She points out that FDA does not require diversity in clinical trials and rarely includes enough older and less healthy patients that tend to rely on Medicare.

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