WASHINGTON — Senate Finance Chair Ron Wyden, D-Ore., is pressing the White House’s nominee to lead the Food and Drug Administration, Robert Califf, to pledge to crack down on drugmakers’ use of fast-track approval pathways as the nominee seeks the chairman’s support.
Wyden’s support of Califf is crucial to his confirmation vote in the closely divided Senate, especially given some other Democrats’ concerns over the nomination. But Wyden’s requests don’t necessarily mean he’s a “no” vote, a Finance Committee staffer said. Several Senate Democrats recently expressed skepticism about voting to confirm Califf, and several, including Sens. Bernie Sanders, I-Vt., and Maggie Hassan, D-N.H., have said they will not confirm the Biden administration’s nominee.
Wyden is concerned that the FDA is not holding drug companies accountable and that drugmakers are taking advantage of the accelerated approval pathway. Califf previously said he sees the promise of the accelerated approval pathway that allows the agency to approve a drug before evidence clearly shows a clinical benefit. Wyden wants to ensure Califf will not allow drugmakers to get away with skirting the agency’s standards.
