Wyden Asks Califf for Details on Accelerated Approval Policy

Nominee to Head FDA Asked for Plan to Hold Drug Companies Accountable for Evidence that Fast-Approved Drugs Work

Washington, D.C. – Senate Finance Committee Chair Ron Wyden, D-Ore., today asked Robert Califf, nominee to lead the Food and Drug Administration (FDA) for details on how he would implement and enforce accelerated approvals for prescription drugs if he is confirmed by the Senate.

“Some companies have taken advantage of the Accelerated Approval Pathway, falling behind on providing confirmatory evidence, while FDA has shied away from using its authority to hold drug companies accountable for fulfilling their obligations,” Wyden said. “The FDA has at its disposal several existing authorities to hold drug companies accountable for failing to complete their confirmatory clinical trials, including the expedited withdrawal of market approval. If confirmed, you agreed to show early on that you are serious about establishing the precedent for FDA’s approach to holding companies to a higher standard.”

In the letter, Wyden asked Dr. Califf for details on how he, if confirmed as FDA commissioner, would set a standard to determine when a company has failed to provide confirmatory evidence and what measures would be taken to hold those companies accountable.

The full letter can be found here.

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