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.
The Accelerated Approval Program allows the FDA to accept evidence from drug companies in a trial that shows an improvement in an indicator of disease but does not yet show a clear clinical benefit, such as longer life spans for patients. Part of the program’s goal is to more quickly approve new drugs that address a serious unmet need. For example, the FDA approved the Alzheimer’s drug Aduhelm under an accelerated approvals pathway. Many drugs approved under these pathways are costly and can raise overall premiums.
During a recent meeting, Califf promised Wyden that if confirmed, he would require companies to provide evidence within 30 days of receiving accelerated approval. Wyden wants Califf to detail what measures he might take if large pharmaceutical companies do not meet this standard and if Califf would call on Congress to help enforce these standards.
“The FDA Commissioner has a powerful role and bully pulpit from which they can advocate for reforms and protect the public interest,” Wyden wrote in a letter to Califf on Friday.