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Regulatory Focus™ > News Articles > 2020 > 9 > Experts call on Hahn to shield FDA from political influence

Experts call on Hahn to shield FDA from political influence

Posted 25 September 2020 | By Michael Mezher 

Experts call on Hahn to shield FDA from political influence

More than 30 leading experts and academics in regulatory science and medicine have signed an open letter calling on US Food and Drug Administration (FDA) Commissioner Stephen Hahn to protect the agency from political interference.
 
The letter comes days after President Donald Trump, who has repeatedly claimed that a coronavirus disease (COVID-19) vaccine could be authorized before the November election and accused FDA staff of being part of “the deep state,” said he may block an anticipated guidance setting stricter standards for COVID-19 vaccine emergency use authorizations (EUAs). (RELATED: Marks, Hahn confirm COVID vaccine EUA guidance coming, Regulatory Focus 11 September 2020; Hahn pledges no politics in COVID vaccine decisions, Regulatory Focus 23 September 2020).
 
“The FDA must remain one of the preeminent public health institutions in the world, as it has been for decades. The FDA’s scientists are highly trained and respected in their fields and perform essential work in protecting Americans from unsafe or ineffective medical products through rigorous evaluation. But in recent months, their ability to do this work in a fair and impartial way appears to have been compromised by political pressure, resulting in several regulatory actions that have threatened the public credibility of the agency,” the letter reads.
 
The letter goes on to demand that Hahn reaffirm FDA’s independence from “partisan political influence” and ensure transparency about the agency’s decision-making with regard to COVID-19 vaccines.
 
Other actions called for in the letter include refraining from issuing an EUA for a vaccine before sharing key data and consulting with other federal agencies, the Infectious Diseases Society of America and FDA’s own Vaccines and Related Biological Products Advisory Committee and publishing review memos from Office of Vaccine Research and Review staff at the time of approval or authorization.
 
“Given how politicized this decision has become, seeking their input and taking seriously their objections before issuing an EUA will do a great deal to affirm public trust that has been lost in the process,” the letter states.
 
Aaron Kesselheim, professor of medicine at Harvard Medical School and one of the authors of the letter, told Focus that the letter is a reaction to the “almost daily stream of concerning statements and tweets coming out of the executive branch about the FDA and in particular the vaccine approval process.”
 
“We thought it was important to take a step back and affirm the basic principles about why the FDA exists and highlight the great work that the FDA’s scientists have done and can still do, when given the appropriate levels of support, in protecting patients and the public health,” he added.
 
Kesselheim said he is frustrated by the “unfair criticism leveled at the FDA,” but feels the agency has made missteps by not asserting its expertise more strongly and distancing itself from political influence.
 
“If and when there is an FDA-approved vaccine, it won’t help unless people are confident enough to use it based on trust in the process and knowledge that the government has the public health — not some political motives — as its primary interest,” Kesselheim said.
 
Letter

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