FDA nomination slips after Biden admin fails to send papers to Congress

A plan to speed Robert Califf’s nomination for FDA commissioner through the Senate next month is on hold after the Biden administration failed to submit the necessary paperwork to Congress in time, three people with knowledge of the matter told POLITICO.

The delay means that Califf is now unlikely to get a confirmation hearing until mid-December at the earliest, effectively ruling out the possibility of a full Senate floor vote on his appointment before the end of the year.

The Senate HELP Committee — which has jurisdiction over the nomination — had hoped to slate Califf’s hearing for the week of Dec. 6, the people with knowledge of the matter said. The proposed timeline would have then given the full chamber a narrow shot at voting to confirm the cardiologist and Obama-era FDA chief before it adjourned, filling President Joe Biden’s highest-profile health policy vacancy.

But that was contingent on the administration submitting required paperwork to the committee by Nov. 19. It missed that deadline, likely pushing Califf’s confirmation vote into January. The document submission is a formality in the confirmation process, but must be completed to ensure senators have all the materials they need to fully consider a nominee.

A Democratic Senate HELP Committee aide said that the panel received Califf’s paperwork on Monday, and was working “to schedule a hearing as soon as possible.”

After this article’s publication, a White House official stressed that there was no hard deadline for submitting the nomination documents, only an “arbitrary timeline.”

The timing issue represents the latest complication in a monthslong effort to install a permanent leader atop an FDA that sits at the center of the Covid-19 response and vaccination campaign.

Even before Biden officially took office, his administration was eyeing longtime career FDA regulator Janet Woodcock to run the agency. But Woodcock ran into opposition from a handful of Senate Democrats over the FDA’s track record on opioid approvals and perceptions she was too close to the drug industry.

The White House spent the next several months seeking alternative candidates, approaching more than a dozen potential nominees before settling on Califf, who headed the FDA for a year in the Obama administration.

The drawn-out process has frustrated FDA staffers exhausted by two years of pandemic pressure and left in the dark on who would be their next permanent leader. It also puzzled some in the broader drug community, who have privately questioned why the administration took so long to find a nominee — only to pick one who was bound to face the same criticisms that were lobbed at Woodcock earlier this year.

Three Democratic senators have already expressed deep reservations about Califf’s candidacy over his connection to the FDA’s decision-making on opioids, as well as his work for a variety of pharmaceutical companies.

Still, the White House is counting on Califf winning some Republican support in the evenly divided Senate, as well as the vast majority of Democrats. HELP Chair Patty Murray has already endorsed his candidacy.

Murray is scheduled to meet virtually with Califf on Dec. 1, the HELP Committee aide said.