FDA Has Legal Power to Impose Faster Drug Withdrawal, Researchers Say

The FDA should be as willing to withdraw an accelerated approval as to grant it, write a team of researchers, arguing for a balance between speed and certainty.

“The pendulum has swung toward speed,” note researchers led by University of Pennsylvania’s Holly Fernandez Lynch in an article published Friday in JAMA Health Forum.

The FDA has “sufficient legal authority right now to require postmarket efficacy studies to verify clinical benefit and to impose expedited withdrawal more expansively than it has to date,” they write, “allowing [the agency] to avoid the current regulatory limbo between traditional and accelerated approval.”

The researchers discuss ways the FDA could improve its withdrawal authority, noting that the agency “could continue to experiment with encouraging sponsors to precommit to voluntary withdrawal … but the terms of such agreements should be explicit and incorporated as formal conditions of approval.”

Drugs or indications also should not “maintain approval if confirmatory studies fail, even while additional confirmatory studies are pursued,” continue the researchers.

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