Lawmakers call on FDA to ensure science, not politics, guides COVID-19 vaccine approval process

Aug 24, 2020
Press Release

WASHINGTON, D.C. – U.S. Reps. Diana DeGette (D-CO), Frank Pallone, Jr. (D-NJ) and Anna Eshoo (D-CA) sent a letter today to the head of the Food and Drug Administration, Stephen Hahn, to ensure science, and not politics, are driving the agency’s COVID-19 vaccine approval process.

The move comes on the heels of FDA’s decision to issue an Emergency Use Authorization for plasma as a treatment for COVID-19, despite public health experts warning there wasn’t yet enough data to support such a move.

“We are increasingly concerned by the political pressure that is being exerted by this Administration on FDA,” the lawmakers 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 – all of whom serve as senior members of the House Energy and Commerce Committee, which directly oversees FDA – expressed to Hahn their desire to see a safe and effective vaccine made available 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 – would drive the process.  

The lawmakers cited President Trump’s recent comments about FDA being part of “the deep state,” and other politically-motivated pressures exerted by the White House, as 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,’” the lawmakers wrote. “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.”

To ensure FDA plans to maintain scientific integrity and all safety protocols throughout the vaccine-approval process, the lawmakers asked the agency to provide answers to the following questions no later than September 4:

  • 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.

A copy of the lawmakers’ letter is available here.