U.S. Reps. Frank Pallone, Jr., (D-NJ), Anna G. Eshoo (D-CA) and Diana DeGette (D-CO) are calling on the Food and Drug Administration (FDA) commissioner to ensure that sound science and the protection of public health alone drive FDA’s COVID-19 vaccine approval process.
“Any political involvement in a future vaccine or treatment threatens to undermine the credibility of the agency, and public confidence in vaccines and treatments approved for use by FDA,” the lawmakers wrote in a letter to FDA Commissioner Stephen Hahn.
Pallone is the chair of the House Energy & Commerce Committee, while Eshoo chairs the Health Subcommittee and DeGette chairs the Oversight and Investigations Subcommittee.
“We are increasingly concerned by the political pressure that is being exerted by this Administration on FDA,” Pallone, Eshoo, and DeGette wrote. “This makes it all the more imperative that FDA take the threat to the public’s vaccine confidence into account when conducting the benefit-risk assessment of a potential COVID-19 vaccine.”
The lawmakers added that Congress’ $8 billion investment in a vaccine was made with the expectation that safety and efficacy – not political expediency – drive the process.
“It is essential that FDA maintain its scientific independence, adhere to required standards and protocols, and as you have repeatedly and recently promised, make decisions ‘based solely on good science and data,’” the lawmakers continued in their letter. “Should political pressure arise, we believe it is your duty to the American people to notify Congress and the American people. Any political involvement in a future vaccine or treatment threatens to undermine the credibility of the agency, and public confidence in vaccines and treatments approved for use by FDA.”
The committee leaders outlined a series of questions for Hahn, including what safeguards are in place to protect against political interference or the appearance of political interference; what assessments, modifications or decisions have yet to be made regarding post-market surveillance, and clarification on FDA’s timeline for completing these steps; and how does FDA plan to ensure that FDA staff understand their obligation to raise concerns, should any arise, including to Congress and the Committee.