FDA nominee Califf pledges to enforce accelerated approval mandates as he jockeys for Senate support

Robert Califf, President Joe Biden’s pick for the top spot at the FDA, has snared the support of the Senate Finance Committee chairman thanks to a vague pledge to reform the agency’s accelerated approval pathway if he’s confirmed.

Sen. Ron Wyden has levied his support for Califf’s bid to become FDA commissioner, the Senate Finance Committee chairman said Thursday.

Wyden’s backing follows the senator’s request last week for Califf to affirm his position on drugmakers following through with evidence gathering after receiving an accelerated approval.

“[I]t is incumbent upon FDA to ensure that the work does not end with the initial approval,” Califf said in a response to Wyden. He said the regulator must make sure drugmakers granted accelerated approval conduct timely confirmatory trials to demonstrate the value of their meds.

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“This will be a high priority for me if I am confirmed to serve as the commissioner of the FDA,” Califf added.

With Califf at the helm, the agency would tap “every authority at its disposal to encourage the diligent initiation of well-designed confirmatory studies,” the nominee said. Califf said he’d welcome the chance to work with Wyden and other members of Congress on extra authorities to fill any gaps in the FDA’s ability to demand prompt studies.

In last week’s letter to Califf, Sen. Wyden argued that the FDA’s accelerated approval pathway “allows the agency to accept lower quality evidence from pharmaceutical manufacturers in order to expedite approval of new drugs…” Some companies have “taken advantage” of the system, he said, adding that the “FDA has shied away from using its authority to hold drug companies accountable for fulfilling their obligations.”

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Wyden posed five questions to Califf, which the nominee mostly avoided answering in his response.

Wyden wanted to know how the FDA would determine whether a company has failed to comply with confirmatory evidence requirements. He also asked Califf how the agency would hold “laggard companies” accountable. Further, Wyden asked how the FDA plans to “measure compliance with clear enforcement standards," among other questions.

Despite his vague responses, Califf managed to win Sen. Wyden's backing—and he'll need all the support he can get. Last month, the Senate Committee on Health approved Califf’s nomination by a slim 13-8 vote. Much of the criticism of Califf centers around his handling of the opioid crisis when he served at the FDA under the former President Barack Obama administration.

Meanwhile, Califf recently made an ethics pledge to win over Sen. Elizabeth Warren. After his potential tenure as commissioner, the nominee has promised to take a four-year break from employment or payment from any drugmaker or medical device company he crosses paths with at the agency.

Califf also promised to remove himself from FDA decisions linked to companies he’s had relationships with for four years, up from an original recusal period of two years. Califf has had gigs at Google’s life sciences outfit Verily, and he’s on the boards of Cytokinetics and Centessa Pharmaceuticals.

The FDA has now gone more than a year without a permanent leader. Califf won the Biden administration's nomination back in October.