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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