New FDA chief can't come soon enough for beleaguered agency

New FDA chief can't come soon enough for beleaguered agency


WASHINGTON (AP) — 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.”

The pressure comes as the FDA faces more coronavirus-related decisions that are likely to affect tens of millions of Americans and determine how the nation fares against future waves of infection.

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 due to their risks to teens.

The FDA role was expected to be one of Biden’s first nominations earlier this year, given the urgency of the...

Full Article