Drumbeat of Calls to Protect FDA From Political Influence Grows

There is no sign of a slowdown in letters to the FDA seeking assurances that the agency will not bend to political pressure to approve a COVID-19 vaccine ahead of the Nov. 3 presidential election.

In the latest missive to FDA Commissioner Stephen Hahn, more than 120 experts and academics urged Hahn to defend the agency against political influence. Posted online last week, the open letter continues to attract new signatures every day.

The agency has previously received multiple letters from lawmakers and others regarding COVID-19 vaccine authorizations. Leaders of the House Energy and Commerce Committee, for example, urged Hahn in a letter to ensure that the vaccine approval process is science-based and not made in response to the administration’s demands (DID, Aug. 26).

In another letter sent early last month, Public Citizen urged the agency not to grant an emergency use authorization as it would raise concerns about a vaccine’s safety and effectiveness, and could scare off patients (DID, Aug. 7).

The E&C committee later called on Hahn to testify about political influence on the agency after he indicated that the agency might issue an EUA for a COVID-19 vaccine before the completion of a phase 3 study. The committee’s leaders later lashed out that the White House for allegedly  blocking Hahn from testifying (DID, Sept. 21).

The committee’s concerns of political pressure prompted separate letters to leading COVID-19 vaccine developers urging them to uphold their joint pledge to make all clinical trial data on their vaccines publicly available (DID, Sept. 16).

The latest letter from the experts and academics, signed by almost 130 individuals as of Tuesday, urges Hahn to release the data on which the agency bases any upcoming decision to authorize or approve a COVID-19 vaccine and to present the decision without exaggerating its benefits or minimizing its harm.

Notable names on the open letter include: Aaron S. Kesselheim, professor of medicine, Harvard Medical School/Brigham and Women’s Hospital; Arthur Caplan, director, division of medical ethics, NYU Grossman School of Medicine; and Amelia Dale Horne, former chief of the vaccine evaluation branch in the FDA’s Center for Biologics Evaluation and Research.

Reports of political pressure on the agency during the pandemic have “threatened the public credibility of the agency,” the letter says, and it urges the commissioner to “publicly challenge claims made by government officials that are inconsistent with the evidence the agency used to make its decisions.”

Hahn has said multiple times that he will not allow the agency to be swayed by political pressure and that he will not overrule any vaccine decisions made by the agency’s career staff (DID, Sept. 11).

Read the full letter here: bit.ly/3mTYxep. — Jordan Williams