FDA's Agenda in Limbo as Biden's Nominee Stalls in Senate
Dr. Robert Califf, an FDA commissioner under President Barack Obama, was viewed as a safe choice who could easily clear the Senate, given his 2016 confirmation by an overwhelming vote, 89-4.
February 09, 2022 at 12:31 PM
6 minute read
President Joe Biden's pick to lead the Food and Drug Administration has stalled in the narrowly divided Senate, an unexpected setback that could delay decisions on electronic cigarettes and a raft of other high-profile health issues pending at the agency.
Biden nominated Dr. Robert Califf for the job in November after a 10-month search that critics complained left a leadership vacuum at the powerful regulatory agency, which has played a central role in the COVID-19 response effort.
Califf, a cardiologist who was an FDA commissioner under President Barack Obama, was viewed as a safe choice who could easily clear the Senate, given his 2016 confirmation by an overwhelming vote, 89-4.
But his latest Senate bid has been snared by political controversies on both the left and right that threaten to sink his nomination and leave the FDA in limbo for months — possibly even until a new Congress convenes next year.
No vote has been set on Califf's nomination as Senate Democrats, the White House and other administration officials make a full-court press to lock up the votes needed to pass the 50-50 chamber. Former FDA officials warn that failure to move on Califf's nomination will make it even harder to find and confirm future nominees.
"If he can't get confirmed it bodes poorly for almost anyone else who could be nominated," said Dr. Stephen Ostroff, who twice served as acting FDA commissioner. "What you're seeing here is a lot of extraneous issues inserting themselves into the confirmation process and the same thing would happen to virtually anyone else nominated."
Five Senate Democrats are opposing Califf due to his consulting work for drugmakers and the FDA's track record of overseeing addictive painkillers that contributed to the U.S. opioid epidemic. That group includes Sens. Joe Manchin of West Virginia and Maggie Hassan of New Hampshire, both from Republican-controlled states ravaged by the epidemic.
With Sen. Ben Ray Luján of New Mexico absent and recovering from a stroke, Democrats need the support of six Republicans to confirm Califf.
The Biden administration remains "incredibly confident" that Califf will be confirmed, according to a White House official who spoke on condition of anonymity to discuss the effort.
Califf will have held one-on-one meetings with 49 senators by the end of this week, according to the official, an extremely aggressive outreach effort for an FDA nominee. Health and Human Services Secretary Xavier Becerra and top White House aides are also lobbying senators on his behalf.
The White House long assumed enough Republicans would support Califf to easily overcome any Democratic defections, given his strong support from the pharmaceutical lobby. Indeed, Califf seemed to be cruising toward confirmation after a cordial hearing before the Senate's health committee in December, which included friendly exchanges with most of its Republican members.
But two days after his appearance the FDA eased longstanding restrictions on abortion pills that allowed women to order them through the mail. Although Califf had no role in that decision, dozens of anti-abortion groups lobbied Republicans to vote against him based on earlier changes impacting the medications while he was at the FDA.
The influential Susan B. Anthony List warned that any Republican senators supporting Califf would lost their 'A+' rating from the anti-abortion group, which has raised tens of millions to support its preferred candidates.
Currently only a tiny handful of Republicans are publicly backing Califf, including Sen. Richard Burr of North Carolina, who represents Califf's home state and is retiring this year, and Sen. Susan Collins of Maine, one of the only remaining pro-choice Republicans in Congress.
A permanent FDA chief can't come soon enough for the beleaguered agency, which has been straining for months under an intense pandemic workload even as several scientific disputes have battered its reputation.
FDA advocates worry the increasing politicization of the nomination process will leave the FDA further adrift without clear direction.
"It is troubling to see Dr. Califf judged on issues that are a very small part of the FDA's responsibilities," said Steven Grossman of the Alliance for a Stronger FDA, which represents industry, patient and consumer groups that interact with the agency. "This narrow focus increases the likelihood there will be more and longer periods when FDA is without permanent leadership."
The White House is unlikely to send another FDA nominee to Capitol Hill if Califf can't clinch 50 votes, noted Grossman, a former HHS and Senate staffer.
In that scenario, the current acting FDA chief, Dr. Janet Woodcock, could continue leading the agency for months to come — potentially into next year. She can serve as acting commissioner as long as Califf's nomination is pending, followed by another 210 days after it is withdrawn or expires, under federal law.
But that's far from ideal. Acting commissioners serve mainly as caretakers and generally cannot set new goals or priorities for the agency.
The FDA has a slate of high-stakes decisions ahead that were expected be made with input from the incoming commissioner. Those choices include whether to ban e-cigarettes linked to the spike in underage vaping by millions of teenagers.
"The more controversial the decisions, the more difficult they become when you're in an acting position," Ostroff said.
The realization that vaping restrictions and other Democratic priorities may be in limbo could help push Califf over the finish line, observers note.
Last week Sen. Elizabeth Warren, D-Massachusetts, announced her support for Califf after he agreed to not work for any pharmaceutical company for at least four years after leaving the FDA. Califf has recently served as a board director or adviser to more than a half-dozen drug and biotech companies, according to his ethics disclosure form.
"I think all this publicity that 'maybe Califf isn't going to make it' is going to get people more focused on why they want Califf there," said Diana Zuckerman, of the nonprofit National Center for Health Research. "I think he still has a very good chance."
Matthew Perrone reports for the Associated Press. AP writer Zeke Miller contributed to this report.
NOT FOR REPRINT
© 2025 ALM Global, LLC, All Rights Reserved. Request academic re-use from www.copyright.com. All other uses, submit a request to [email protected]. For more information visit Asset & Logo Licensing.
You Might Like
View AllRead the Document: DOJ Releases Ex-Special Counsel's Report Explaining Trump Prosecutions
3 minute readUS Judge OKs Partial Release of Ex-Special Counsel's Final Report in Election Case
3 minute readSpecial Counsel Jack Smith Prepares Final Report as Trump Opposes Its Release
4 minute readTrending Stories
- 1MLB's Texas Rangers Search For a New GC and a Broadcasting Deal
- 2Does the Treasury Hack Underscore a Big Problem for the Private Sector?
- 3Gen AI Legal Tech Startup Eve Raises $47 Million Series A Investment
- 4Hicks Johnson Promotes Lori Arakaki and Daniel Scime to Firm Partnership
- 5Buchalter Opens in Chicago With 25 Lawyers, Staff
Who Got The Work
J. Brugh Lower of Gibbons has entered an appearance for industrial equipment supplier Devco Corporation in a pending trademark infringement lawsuit. The suit, accusing the defendant of selling knock-off Graco products, was filed Dec. 18 in New Jersey District Court by Rivkin Radler on behalf of Graco Inc. and Graco Minnesota. The case, assigned to U.S. District Judge Zahid N. Quraishi, is 3:24-cv-11294, Graco Inc. et al v. Devco Corporation.
Who Got The Work
Rebecca Maller-Stein and Kent A. Yalowitz of Arnold & Porter Kaye Scholer have entered their appearances for Hanaco Venture Capital and its executives, Lior Prosor and David Frankel, in a pending securities lawsuit. The action, filed on Dec. 24 in New York Southern District Court by Zell, Aron & Co. on behalf of Goldeneye Advisors, accuses the defendants of negligently and fraudulently managing the plaintiff's $1 million investment. The case, assigned to U.S. District Judge Vernon S. Broderick, is 1:24-cv-09918, Goldeneye Advisors, LLC v. Hanaco Venture Capital, Ltd. et al.
Who Got The Work
Attorneys from A&O Shearman has stepped in as defense counsel for Toronto-Dominion Bank and other defendants in a pending securities class action. The suit, filed Dec. 11 in New York Southern District Court by Bleichmar Fonti & Auld, accuses the defendants of concealing the bank's 'pervasive' deficiencies in regards to its compliance with the Bank Secrecy Act and the quality of its anti-money laundering controls. The case, assigned to U.S. District Judge Arun Subramanian, is 1:24-cv-09445, Gonzalez v. The Toronto-Dominion Bank et al.
Who Got The Work
Crown Castle International, a Pennsylvania company providing shared communications infrastructure, has turned to Luke D. Wolf of Gordon Rees Scully Mansukhani to fend off a pending breach-of-contract lawsuit. The court action, filed Nov. 25 in Michigan Eastern District Court by Hooper Hathaway PC on behalf of The Town Residences LLC, accuses Crown Castle of failing to transfer approximately $30,000 in utility payments from T-Mobile in breach of a roof-top lease and assignment agreement. The case, assigned to U.S. District Judge Susan K. Declercq, is 2:24-cv-13131, The Town Residences LLC v. T-Mobile US, Inc. et al.
Who Got The Work
Wilfred P. Coronato and Daniel M. Schwartz of McCarter & English have stepped in as defense counsel to Electrolux Home Products Inc. in a pending product liability lawsuit. The court action, filed Nov. 26 in New York Eastern District Court by Poulos Lopiccolo PC and Nagel Rice LLP on behalf of David Stern, alleges that the defendant's refrigerators’ drawers and shelving repeatedly break and fall apart within months after purchase. The case, assigned to U.S. District Judge Joan M. Azrack, is 2:24-cv-08204, Stern v. Electrolux Home Products, Inc.
Featured Firms
Law Offices of Gary Martin Hays & Associates, P.C.
(470) 294-1674
Law Offices of Mark E. Salomone
(857) 444-6468
Smith & Hassler
(713) 739-1250