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 Pulse, in “Could ACIP Delay Wind Up in Court?” by David Lim and Lauren Gardner.
Following is an excerpt:
ACIP LEGAL FALLOUT — The Trump administration’s delay of what was supposed to be this week’s regularly scheduled meeting of the CDC’s vaccine advisers — and its anticipated overhaul of the panel — raised questions about what legal recourse drug companies and others might have.
As we’ve reported since now-HHS Secretary Robert F. Kennedy Jr.’s star rose with President Donald Trump’s electoral win, the department head has vast discretion to remake the Advisory Committee on Immunization Practices — and Kennedy plans to replace at least some of them because of perceived conflicts of interest.
But it may not be so simple.
The CDC typically adopts the ACIP’s recommendations, which have become an integral step in ensuring both clinical use and insurance coverage of newly approved vaccines.
References to the committee and its expected actions have been baked into federal and state laws — 2016’s 21st Century Cures Act directs the panel to consider any new vaccines or indications at its next meeting following FDA approval, and 2022’s Inflation Reduction Act requires ACIP-recommended shots covered under Medicare Part D to be offered at no cost to beneficiaries.
ACIP also votes on whether a pediatric vaccine should be added to the Vaccines for Children program, which offers shots at no cost to low-income kids.
“A court should most certainly look at the history and the context in addressing any action” that affects the committee’s work, said Richard Hughes IV, a lawyer at Epstein Becker Green and a former Moderna executive.
