FDA Caught in Political Crossfire

Despite the agency’s remarkable success in speeding vital new vaccines and therapies to patients to combat the COVID-19 pandemic, while also continuing to advise on and approve a broad range of vital medicines, FDA officials have been under attack. The regulators either are acting too fast and risking public safety—or too slow, mired in rules while ignoring important scientific findings.

A main difficulty is that the agency has lacked a confirmed leader for the past 10 months, making it difficult to set priorities and explain actions within the Biden administration and to the public and policymakers. As acting commissioner, Janet Woodcock has maintained a steady hand on this diverse agency that oversees a vast range of products vital to public health. In addition to vaccines and new drugs, FDA has been in the spotlight recently over its efforts to limit marketing of e-cigarettes to halt the dangerous vaping epidemic among young people. The agency is responsible for assuring the safety of much of the nation’s food supply, veterinary medicines and dietary supplements. Plus its regulation of cannabis products and cosmetics are under debate. FDA’s oversight of medical devices and diagnostics has put it in the hot seat for shortages of critical products for protecting medical personnel and for providing fast and accurate public testing for COVID infection. And there’s the continuing wave of false claims about popular treatments to combat the pandemic, some dangerous and most ineffective.

Earlier in the year, it looked likely that Woodcock would become FDA’s permanent commissioner, but that was sidelined by some Democrats and public health officials upset by the agency’s earlier approval of what turned out to be deadly opioid pain killers that are easily abused. As the long-time head of drug development and approval at the Center for Drug Evaluation and Research (CDER), Woodcock also was accused of working too closely with biopharma companies in accelerating the development and marketing of important new therapies, some turning out to have limited long-term benefits—and many posting high price tags. Although patient advocates and research groups have championed Woodcock for providing strong leadership in shifting FDA away from a more risk-averse stance, that approach has been challenged. The result is that the White House has delayed in selecting an FDA commissioner, even though federal rules require Woodcock to vacate her acting position by mid-November unless the administration nominates a new commissioner, permitting her to continue on during the Senate confirmation process.

The situation has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints. The recent debate over approval of booster shots for anti-COVID vaccines is a case in point, with FDA compelled to manage President Biden’s promise to provide third shots by late September amidst highly publicized internal agency dissension on the issue. Leading FDA vaccine officials contended that the agency was ignoring the scientific evidence in authorizing booster shots and that such a policy was inappropriate when initial vaccines were desperately needed by much of the third world.

That dispute over vaccines followed an even more blistering debate over FDA approval of a costly new treatment for Alzheimer’s disease, Biogen’s Aduhelm, based on questionable and very limited clinical evidence. The approval decision by CDER officials was blasted by members of Congress, the medical community and even some patient groups, but justified by the reviewers as likely to provide some benefit to some patients who lacked any alternative treatment for this devastating disease. Continued charges of FDA officials caving to industry pressures, though, prompted Woodcock to seek an independent review of the approval process for the drug from the HHS Inspector General.

These developments have generated media reports on tumult and dissension at FDA and continued criticism about the agency putting industry interests above the needs of public health. The Aduhelm decision was blamed for undermining FDA’s “gold standard” for ensuring drug safety and efficacy and linked to the agency’s dependence on industry-paid user fees for shifting the balance away from careful oversight and toward too-speedy approvals.

Such charges gain support from several departures of long-term agency. Most visible was the recent announcement of retirement by top vaccine approval officials, Marion Gruber and Phillip Krause, director and deputy director of the Office of Vaccine Research & Review (OVRR) in the Center for Biologics Evaluation and Research (CBER). At the same time, many leading staffers who have been at FDA for decades have announced retirement plans, such as Theresa Toigo, CDER associate director for drug safety operations.More departures are expected, as many FDA officials past retirement age are exhausted from the pressures of the past year and now seek to move on after postponing their departures during the height of the public health emergency. Public scorn for the agency’s efforts to evaluate reams of data as fast as possible has tipped the balance in favor of leaving the public spotlight.

Meanwhile, agency veteran Woodcock has worked with her staff to keep review and regulatory decisions on track. Industry leaders have supported her for the top job, but went quiet as the administration signaled that would not occur. Woodcock opened the recent annual “Convergence” conference sponsored by the Regulatory Affairs Professionals Society (RAPS) by citing FDA’s efforts to ensure access to needed diagnostics, vaccines and therapeutics during the health emergency, and in meeting the challenges in conducting clinical trials, inspecting drug and food facilities, and issuing “reams of guidances” to facilitate emergency use authorizations for vital vaccines, drugs and diagnostics—while also keeping up with the usual volume of premarket reviews of innovative products.

Woodcock concluded by expressing hope that these efforts in dealing with the pandemic will create “at least among some people” a “renewed appreciation for the importance of science, technology, and data.” She said she looks forward to a greater understanding of the “essential role play by the FDA and other public health agencies” in responding to this crisis and in protecting and promoting public health.

Jill Wechsler is Pharm Exec’s Washington Correspondent. She can be reached at jillwechsler7@gmail.com.