Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) today sent a letter to Food and Drug Administration (FDA) Commissioner Stephen Hahn calling on him to ensure that sound science and the protection of public health alone drive FDA’s COVID-19 vaccine approval process.
“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 three Committee leaders expressed a shared desire to see a safe and effective vaccine made available to the American people as soon as possible, but pointed out that Congress’ $8 billion investment in a vaccine was made with the expectation that safety and efficacy - not political expediency - drive the process. They wrote that while Commissioner Hahn’s past statements on the subject were encouraging, President Trump’s recent lies about FDA being part of “the deep state," and other politically motivated pressures exerted by the White House, are gravely concerning.
“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,’" Pallone, Eshoo and DeGette continued. “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."
In addition to seeking reassurance that FDA will maintain scientific integrity and all safety protocols throughout the vaccine approval process, the Committee leaders also outlined a series of questions for which they seek answers by September 4. Their questions include:
* What safeguards are in place to protect against political interference or the appearance of political interference;
* What actions FDA plans to take to ensure that safety and efficacy alone will guide vaccine approval;
* What assessments, modifications or decisions have yet to be made regarding post market surveillance, and clarification on FDA’s timeline for completing these steps;
* Whether all materials and recommendations related to a COVID-19 vaccine candidate will be made available to the public in real time; and
* How FDA plans to ensure that FDA staff understand their obligation to raise concerns, should any arise, including to Congress and the Committee.
