FDA panel recommends revoking the approval of controversial drug for preterm births
NBCAUG 2022
This drug’s ineffectiveness exposes the flaws in the FDA's accelerated approval program. After approval, drug companies are required to conduct follow-up tests, but there’s no timetable and no incentive for doing so. Drugs that don’t work, or might even cause harm, are allowed to remain on the shelves for too long after approval.
The FDA's accelerated approval track isn’t perfect, but it’s necessary. In some cases, it could take decades to learn if a drug is an effective cure, and many with terminal diseases don’t have that type of time. With willing recipients of the drugs on hand — and the FDA enforcing necessary tests and requiring confirming data from companies — this program has been, and should continue to be, a positive.