STAT+: Key Democrat moves to crack down on FDA accelerated approvals

Rep. Frank Pallone’s new bill would dramatically crack down on the Food and Drug Administration's so-called accelerated approval program.

WASHINGTON – A powerful Democratic lawmaker has introduced a bill that would dramatically rein in the Food and Drug Administration’s so-called accelerated approval program.

Under accelerated approval, the FDA can approve drugs without clear evidence that they actually prolong patients’ lives, so long as drug companies complete follow-up studies and demonstrate that the therapies actually do have a “clinical benefit.” The bill, which was introduced Monday by the chairman of a key health panel, Rep. Frank Pallone (D-N.J.), would make it easier for the FDA to crack down on drug companies that do not complete those follow-up studies.

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