UPDATE: Feb. 16, 2022: Medtech lobby groups congratulated Robert Califf after he was confirmed as FDA commissioner on Tuesday, ending a lengthy process where the helm of the agency remained vacant. Califf rejoins the agency at a critical period, as the COVID-19 pandemic continues, and the FDA makes key decisions about how medical devices and tests will be regulated in the future.
AdvaMed, the lobbying group for medtech companies, praised Califf’s confirmation in a Tuesday statement.
"Now more than ever, FDA requires steady leadership as the country emerges from the pandemic," AdvaMed Chairman Mike Minogue, who is also the CEO of Abiomed, said in the news release. "We look forward to working with Commissioner Califf on our common goal of ensuring that the innovative medical technologies patients and providers rely on are safe and effective."
Device makers are currently locked in protracted discussions with the FDA over the Medical Device User Fee Amendments V, which provides the agency funds to review medical devices. The FDA had missed its Jan. 15 deadline to send the final agreement to Congress, with AdvaMed recently citing a "number of roadblocks," although the industry group didn’t elaborate on the specific points of contention.
The American Clinical Laboratory Association (ACLA) and Medical Device Manufacturers Association also issued remarks supporting the FDA's new leadership. At the same time, the ACLA also pointed out the role of lab-developed tests and in-vitro diagnostic test kits during the pandemic. In November, HHS reversed a Trump-administration directive, now requiring lab-developed tests to get an emergency use or traditional marketing authorization from the FDA.
Tom Sparkman, ACLA's senior vice president of government affairs and policy, said in a news release that the industry group's leaders "look forward to working closely" with Califf, while also recommending that the FDA eliminate "unnecessary and counterproductive regulatory policies that create uncertainty and impose unnecessary burdens on test development, especially as the pandemic lingers.
The U.S. Senate on Tuesday voted to confirm Robert Califf as commissioner of the Food and Drug Administration, filing a position that had remained vacant for more than a year despite the agency playing a leading role in the nation's response to the COVID-19 pandemic. The final vote was 50-46 in favor of Califf's confirmation.
Republican support proved crucial for President Joe Biden's nominee, as a group of Democrats opposed Califf over the FDA's approval of opioid painkillers during his first stint as FDA commissioner and deputy, as well as over his ties to the pharmaceutical industry.
"He's the leader we need today, but also for the future," Sen. Richard Burr, R-N.C., the senior Republican on the Senate Health, Education, Labor and Pensions Committee, said before the vote. "There's never been a more critical time for the FDA to have effective leadership." Five other Republicans joined 43 Democrats and independent Sen. Angus King of Maine in voting for Califf.
Sen. Joe Manchin, D-W.Va., led Democratic opposition to Califf, forcefully arguing that the agency's stance on opioids would not change under Califf.
"This administration under Dr. Califf will take the same-old same old policies as before," he said.
Now confirmed, Califf will take the reins as the agency's 25th commissioner with a long agenda in front of him. The FDA has been led on an interim basis by Janet Woodcock, formerly the head of the agency's drug review division and at one point viewed as a likely candidate for Biden's nomination. However, a permanent chief will have more authority to set far-reaching policies, even though Woodcock has considerable influence at the agency.
Continuing the FDA's response to the pandemic will be an immediate task for Califf. While the agency has already made many of the biggest COVID-19 decisions such as emergency authorizations and approvals for three vaccines and a handful of treatments, it still has important decisions ahead on whether to clear shots for young children and whether further boosters are needed.
Should new variants emerge, agency officials will be called upon to quickly review data on whether existing vaccines and treatments retain their potency and make calls on whether to stop distribution of ineffective drugs.
Meanwhile, COVID-19 may be leading to increased staff turnover at the regulator. FDA leaders like Woodcock and vaccines division head Peter Marks have both cited the pandemic's burden on agency staff, and several top reviewers have recently announced plans to depart or retire.
Other important policy decisions will confront Califf as well. The agency's procedures for accelerated drug approval are under scrutiny in large part because of its controversial decision last year to clear Biogen's Alzheimer's disease drug Aduhelm. Pharmaceutical companies also are often slow to complete confirmatory clinical trials, adding to criticism that the FDA too willingly approves drugs that aren't yet proven to help patients.
Richard Pazdur, head of FDA's cancer drug review division, recently made a point of toughening the agency's stance as it relates to cancer medicines, but it's not clear whether his push will extend to other divisions as well.
Califf this year also will be called upon to shepherd through renewal of the program that funds the bulk of drug reviews, called the Prescription Drug User Fee Act. While usually developed on a bipartisan basis and negotiated with industry and consumer advocates, this legislation often becomes a vehicle for lawmakers to attach new requirements on the FDA.
Califf served as FDA commissioner in the final year of President Barack Obama's administration, when he was elevated from a position as deputy commissioner. Lawmakers raised objections over opioid policies then, too, but his confirmation was cleared by a much more decisive 89-4 vote.
This time around, there was more sustained opposition, drawing out the nomination process over three months. Manchin and Sen. Mike Braun, R-Ind., even wrote an op-ed in USA Today against Califf, noting the FDA approved five opioids while he was commissioner in 2016 and 2017.
Backing Califf, on the other hand, were former FDA commissioners Scott Gottlieb, Margaret Hamburg and Mark McClellan, who, along with former Medicare chief Andy Slavitt, pointed out in an op-ed in The Hill that Califf helped design trials aimed at preventing and treating opioid addiction.
Before joining the FDA, Califf was a cardiologist and researcher at Duke University who was known for his contribution to modernizing clinical trial design. After leaving the FDA the first time, he advised Google and joined its life sciences spinoff Verily as a health policy expert.
Correction: This story has been updated to correct the number of Democratic votes in favor of confirming Califf.
Elise Reuter contributed to this update
