Reports say Azar is asserting control over FDA as vaccine trials near completion, while Hahn is blocked from testifying on COVID-19.
FDA’s role in approving of one or more coronavirus vaccines—especially before the Election Day November 3—came under fresh scrutiny this weekend, amid reports that HHS Secretary Alex Azar has asserted greater control over the agency and Commissioner Stephen Hahn, MD, was blocked from testifying before Congress.
The New York Times first reported that Azar issued a memo on Tuesday barring the nation’s top health agencies, including FDA, from having the last word on any new rules on food, drugs, medical devices, or other products, which would include vaccines. The Times said it had obtained the memo, which said that final sign off “is reserved for the secretary.”
The report said the memo did not make clear whether the process for evaluating and approving vaccines for coronavirus disease 2019 (COVID-19) would be altered. Three such vaccines are in phase 3 clinical trials. News of the memo comes as AstraZeneca, one of the companies with a vaccine in late-stage development, released details of its trial over the weekend, following two separate halts following adverse events in trial participants. The study has resumed elsewhere but is still on hold in the United States, according to The Times.
Observers familiar with the FDA warned that this latest episode would only fuel public fears that political concerns, not science, were driving vaccine development. On September 8, pharmaceutical companies behind leading vaccine candidates responded by signing a pact that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.” Besides AstraZeneca, those signing include Pfizer, Moderna, Johnson and Johnson, and Sanofi.
Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest, told The Times the new policy was “a power grab” that could slow routine regulatory processes. Lurie is a former associate commissioner of the FDA.
The FDA memo comes the same week that the Trump administration, under pressure, withdrew a heavily criticized CDC guideline on COVID-19 testing after it was revealed the document had been posted on the agency’s website over the objection of its scientists.
Hahn blocked? Meanwhile Friday, two Democrats from the House Energy and Commerce Committee issued a statement saying the White House had blocked FDA’s Hahn from testifying before their panel with a scheduled update on the agency’s response to COVID-19.
Chairman Frank Pallone, D-New Jersey, and Health Subcommittee Chair Anna Eshoo, D-California, said in their statement, “The American people deserve to hear Commissioner Hahn’s response to those concerns during a public hearing and what actions he is taking to ensure that the agency’s COVID-19 decisions remain science-based. The White House’s muzzling of the FDA’s top scientist further injures public trust and confidence in FDA.”
Hahn did appear Friday on Twitter: “I am often asked about how and when FDA will authorize or approve a vaccine to protect against COVID-19. Here is my answer: when the agency’s scientific experts have completed their review and are ready to do so, and not a moment before.”