Skip to Main Content

WASHINGTON — Has Congress’s watchdog agency just given Tennessee Senator Lamar Alexander the ammunition he needs to push a stalled biomedical reform through the Senate?

The Government Accountability Office on Wednesday issued two critical reports suggesting that the Food and Drug Administration isn’t properly planning how to keep pace with medical science.


One report notes that the FDA lacks goals, targets, and time frames for keeping up with scientific advances — and also fails to track the money it spends on these efforts. The other finds fault with the FDA’s strategic plan, which is supposed to speed approvals of drugs and devices, especially combination medical products, such as heart stents that also deliver blood thinners to prevent clots.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!