Biologics

House E&C Committee Wants Politics Out of Vaccine

David McFarland

— 2 min read
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The three Democratic leaders of the House Energy and Commerce Committee have written to FDA commissioner Stephen Hahn seeking assurance that science and the protection of public health will drive agency decisions to authorize or approve a Covid-19 vaccine, and not political expedience. The 8/24 letter was sent several days after Trump administration officials complained about the pace of FDA actions and FDA then issued an emergency use authorization (EUA) for coronavirus blood plasma as a treatment.

“The trust of the American people and the health of the nation depend on FDA and the Trump administration abiding by this standard,” wrote Reps. Frank Pallone (D-NJ), Anna Eshoo (D-CA), and Diana DeGette (D-CO). The three praised FDA’s actions “to provide leadership and expertise on the required evidence and safety considerations for the future authorization or approval of a Covid-19 vaccine.” They referenced the agency’s June guidance and other statements on how it will approach vaccine approval.

The representatives project that due to the time needed to enroll and conduct Phase 3 trials and the duration of minimum safety monitoring requirements in the FDA guidance, it is unlikely that a Covid-19 vaccine will be approved before the spring of 2021.

Referring to the administration’s statements last week, the representatives said, “As FDA commissioner it is your responsibility to lead and defend the agency, yet when the President and his chief of staff accused FDA of being part of the ‘deep state’ you remained silent. Unfortunately, this is merely the latest example of science being politicized throughout the Trump administration’s Covid-19 response.”

The letter asks for responses to these questions: 

  •          What safeguards are in place to mitigate against any political pressure from the President, the White House, and HHS, and also to protect even the appearance of any political interference or expediency?
  •          What further actions will FDA take to ensure that the evidence of safety and efficacy of a future vaccine will guide any decision to issue an EUA before full licensure approval of a Covid-19 vaccine?
  •          What, if any, remaining discussions, infrastructure assessments and modifications, and decisions must be made about post-market surveillance before vaccine authorization or licensure, and what is the timeline for completing these steps?
  •          Will all meetings, materials, and recommendations made by the Vaccines and Related Biological Products Advisory Committee related to a Covid-19 vaccine or vaccine candidate be made public in real-time? Detail what components will be publicly available and how they will be released to the public.
  •          What steps will be taken to communicate to FDA staff their obligation to raise all concerns about political interference undermining FDA’s public health mission and science-based authority, as well as options available to them, including contacting Congress or the committee?

“Should political pressure arise,” the representatives wrote, “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.”

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