A sign marks the headquarters for the Food and Drug Administration in Silver Spring, Md., in this file photo. After nearly nine months of searching, President Joe Biden says he’s close to naming his choice to lead the FDA. (AP)
WASHINGTON — Straining under a pandemic workload and battered by a string of public controversies, one of the leading agencies in the government’s fight against covid-19 is finally on the verge of getting a new commissioner.
After nearly nine months of searching, President Joe Biden says he’s close to naming his choice to lead the Food and Drug Administration, which oversees vaccines, drugs and tests. Former FDA officials and other experts say the decision cannot come soon enough for the agency’s beleaguered regulators.
Thousands of FDA staffers are exhausted after racing for more than a year and a half to review products to battle the coronavirus, and the agency’s reputation for rigorous, science-based regulation has been threatened by contentious disputes over covid-19 booster shots and an unproven new Alzheimer’s drug.
“The FDA is under a cloud like we’ve never seen before,” said Lawrence Gostin, a public health specialist at Georgetown University. “The choice of a commissioner is going to be absolutely essential for a vibrant future for the agency.”
In the coming weeks, the agency will decide on the scope of booster shots for adults who received the Moderna and Johnson & Johnson vaccines. Regulators will also rule on whether Pfizer’s vaccine is safe and effective for children as young as 5.
That comes atop other high-stakes decisions, including whether to ban e-cigarettes from vaping giant Juul and other manufacturers because of their risks to teens.
Nominating someone for the FDA role was expected to be a priority earlier this year, given the urgency of the pandemic. But the agency’s longtime drug director, Dr. Janet Woodcock, has been serving as acting commissioner since January. The White House faces a legal deadline of mid-November to name a replacement.
Administration officials say Biden will make a decision before Nov. 15. The news this week that Dr. Francis Collins will be stepping down from his post leading the National Institutes of Health has added new urgency to resolve the question of FDA leadership.
That issue came into sharp focus last month when two longtime FDA vaccine regulators publicly opposed the Biden administration’s plan to give boosters to most healthy Americans. Both said they would retire from the agency.
Headquartered in the Maryland suburbs outside Washington, the FDA is often cited as regulating products that make up 25% of U.S. consumer spending. At the center of this sprawling bureaucracy, the FDA commissioner is subject to pressure from the White House, members of Congress, corporate lobbyists, consumer advocates and medical groups.
More than a half-dozen names have been floated for the position since Biden took office.
Former FDA Deputy Commissioner Dr. Joshua Sharfstein, the agency’s No. 2 official in the early Obama administration, was an early favorite among medical experts and consumer advocates. But he is opposed by many of the powerful industries that the FDA regulates, including the pharmaceutical lobby.
Dr. Michelle McMurry-Heath, who also worked at the FDA under Obama, has also reportedly been vetted for the job. But her current role heading the biotech industry’s top lobbying group puts her at odds with several key Biden priorities, including lower drug pricing.
For months, Woodcock was expected to be nominated, given her popularity among FDA staff and the drug industry. But several key Democratic senators have signaled they would oppose her confirmation because of the FDA’s handling of addictive opioid painkillers like OxyContin under her watch.