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Pressurized political, COVID climates greet his return to top spot.
The heightened political debate that delayed his Senate confirmation, plus continued challenges created by the COVID-19 pandemic, ensure that Dr. Robert Califf’s tenure leading FDA will be much more contentious than his previous stint. His Senate confirmation process was punctuated by sharp queries from both sides of the aisle about access to COVID tests and therapies, agency policies for speeding new drugs to market, and FDA’s role in facilitating access to both long-acting opioids and to medicine to induce abortions, as the politicians sought to make points with constituencies leading up to mid-term Congressional elections in November.
That partisan tone was apparent in January as the Senate Health, Education, Labor & Pensions (HELP) Committee voted to advance his nomination as FDA commissioner by a close 13 to margin.1 Final Senate approval by an historically narrow 50-46 vote came only after the White House and Califf’s supporters lobbied hard to gain sufficient support, a success that is very different from Califf’s 89-4 approval back in 2016. Four Democrats and independent Bernie Sanders opposed the nomination, citing Califf’s close ties to industry and his failure to halt access to opioids. Califf won the vote of Sen. Elizabeth Warren (D-MA) and some others by agreeing to extend ethics restrictions on his future involvement with industry.
Only six Republications voted for confirmation, led by HELP Committee ranking Republican Richard Burr of North Carolina, who championed the appointment of his fellow Carolinian as a knowledgeable scientist and experienced policymaker. Most Republicans preferred to rail against FDA’s “pro-abortion agenda,” amid the agency’s recent decision to remove curbs on prescribing and dispensing medications that induce abortion at early stages of pregnancy.
Califf’s first order of business is to support the development and approval of drugs, vaccines, and diagnostics vital to taming the ongoing coronavirus pandemic. FDA’s recent decision to delay consideration of a COVID vaccine for very young children indicates that many difficult scientific and legal issues remain on the agency’s agenda. Califf will benefit considerably from the experience and assistance of Acting Commissioner Janet Woodcock, who as agreed to remain at the agency as his principal deputy commissioner.2
An immediate challenge for the commissioner is to revisit and clarify the risks and benefits of the agency’s accelerated approval (AA) programs and to ensure completion of required confirmatory trials. Califf promised such an effort to several uncertain senators concerned about FDA’s approval of and access to the Alzheimer’s drug Aduhelm and about a proposal from the Centers for Medicare and Medicare Services (CMS) to limit Aduhelm prescribing to patients participating in clinical trials. If adopted, the coverage with evidence development requirement could apply to similar Alzheimer’s treatments moving through the R&D pipeline, which has raised fears of discouraging further research in the Alzheimer’s field by patient groups and biopharmaceutical companies. The situation has fueled debate over FDA’s reliance on limited evidence in assessing new products under the AA process and the scope and timing of post-approval confirmatory studies. Meanwhile, the Department of Health and Human Services (HHS) inspector general is investigating the Aduhelm approval decision by the Center for Drug Evaluation and Research (CDER) and whether reviewers behaved properly in weighing the risks and benefits of the therapy.
Patient advocates also want FDA to increase diversity in medical product research and to advance treatments for rare diseases, improved antibiotics, and safer gene and cellular therapies. Pressure to help control the high cost of prescription drugs will continue to drive FDA support for developing complex generic drugs and biosimilars. FDA has taken action against scores of clinics and operations promoting unapproved COVID treatments, many presenting serious health risks to consumers.
Oversight of drugs and medical products is only one area presenting many hot-button issues for FDA’s leadership to track and tackle. There is pressure to clarify rules governing e-cigarettes amid concerns about flavored products luring young people into tobacco use. FDA also has to address serious health problems arising from contaminated food and seafood, including significant volumes of imported products. The safety of cosmetic products, dietary supplements, sunscreens, and other non-prescription products raise additional complex issues, many described in FDA’s annual report for 2021, which outlines these and several other high-priority regulatory programs.3
Amid all these programs, probably the most consequential assignment for FDA’s leader is to win Congressional support for agency funding and resources. This year, that entails the timely approval of new user fee agreements on drugs, generic drugs, biosimilars, and medical devices as part of a larger legislative package that must be passed by Sept. 30. Califf comes to the job with valuable experience in these areas, which he will need to manage the many controversial decisions and heavy political pressures ahead.
Jill Wechsler is Pharm Exec’s Washington Correspondent. She can be reached at firstname.lastname@example.org.