BioPharma, Policy, Legal

La FDA, c’est moi: In memo, HHS’ Azar asserts power to sign new rules, traditionally purview of agencies’ lawyers

The New York Times reported that in a memo, Alex Azar stated that the power to sign new rules is “reserved” for him, a move that one expert called a “power grab.” It is unclear how it will affect authorizations of vaccines against the coronavirus.

The head of the Department of Health and Human Services has sent out a memo that experts say would make it harder for the Food and Drug Administration and other agencies under the department to issue new rules regarding drugs, vaccines, medical devices and other products, according to a news report.

Citing the document and calling it a “stunning declaration of authority,” The New York Times reported Saturday that the memo, written by HHS Secretary Alex Azar last Tuesday, asserted that power to sign new rules is “reserved to the Secretary.” However, it is unclear whether the memo would change the way vaccines against the Covid-19 virus, SARS-CoV-2, are vetted or authorized. The memo would take the power to sign new rules from the agency lawyers who usually do it and hand it to Azar.

The article cited experts as expressing worry that the memo could exacerbate perceptions that the Trump administration is meddling in what are supposed to be scientific decisions by agencies like the FDA and Centers for Disease Control and Prevention. One expert called the move “a power grab.”

Concerns have grown in recent weeks about politicization of FDA decisions, particularly around therapeutics for Covid-19 and vaccines against the virus that causes it. In a town hall last week, Democratic presidential candidate Joe Biden said he does not trust President Trump on vaccines and instead trusts Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases.

FDA Commissioner Stephen Hahn has been the recipient of significant criticism amid allegations that he has allowed political influence over the agency’s decisions. These include accusations that the emergency use authorization granted for plasma taken from recovered Covid-19 patients was made for political considerations, while Hahn himself was criticized for not standing up for FDA staffers when Trump baselessly accused the agency of acting as a “deep state.” That criticism was renewed when Hahn told The Financial Times he would be open to allowing the authorization of a vaccine before Phase III clinical trials were complete.

Photo: Tasos Katopodis, Getty Images