Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO, in “FDA Set to Unveil New Covid Vax Guidelines Today,” by Lauren Gardner and David Lim.
Following is an excerpt:
LOOKING INTO VAX CRYSTAL BALL — The Covid-19 vaccine framework that FDA Commissioner Marty Makary teased last week is expected to drop today, two people familiar with the plan and granted anonymity to discuss the timing told Prescription Pulse. An FDA YouTube event indicates that Makary and vaccine chief Vinay Prasad will speak on “an evidence based approach to Covid vaccination” at 1 p.m. today.
While details of the guidance remain closely held, some clues are likely found in the FDA’s late Friday letter approving Novavax’s Covid vaccine.
Who can get it: The license covers a limited population — adults 65 and older and people ages 12 to 64 with at least one underlying condition putting them at high risk for severe disease — compared with the two messenger RNA shots available for Covid recommended for all people 12 and older.
The universe of individuals considered high-risk isn’t small, based on the CDC’s list of relevant conditions, and the agency’s outside-expert panel is expected to vote next month on narrowing the scope of people recommended to receive Covid vaccines. But that treatment discrepancy — and the FDA label’s venture into the CDC’s typical territory of recommending vaccination practices — has raised concerns among public health experts.
“They made that decision for the CDC. It’s really not theirs to do,” Dr. Paul Offit, a pediatrician who serves on the FDA’s vaccine advisory panel, said of the FDA. “The FDA is a regulatory body; the CDC is a recommending body.”
Richard Hughes, a vaccine lawyer at Epstein Becker Green, questioned whether the FDA’s “policymaking” in the Novavax approval could be considered arbitrary and capricious — a common judicial review standard for federal decisions.
“Was this based on a whim, or was it based on science? And if it was based on science, what science was it based upon?” he asked.
