If Trump bypassed the FDA on a COVID-19 vaccine it could ‘upend’ the traditional approval structure and erode the public’s trust in the executive agency, expert says

• President Donald Trump suggested that the White House could bypass the US Food and Drug Administration on approving a coronavirus vaccine. 
• Marc Sanchez, an FDA attorney, and consultant, said the remark was an “unfortunate attempt to increase the pressure on the FDA.”
• Sanchez said doing that would erode public trust in the agency and in a vaccine. 
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President Donald Trump suggested on Wednesday that the White House could bypass the US Food and Drug Administration on approving a coronavirus vaccine.

Marc Sanchez, an FDA attorney and consultant, said doing so would not only “upend” the FDA’s structure but erode the public’s trust in the agency to roll out a safe and vaccine on its own.

Sanchez said the comment was an “unfortunate attempt to increase the pressure on the FDA.”

“FDA has historically been slower than its counterparts around the world in approving novel medical devices and drugs, taking seriously the role of protecting public health and safety over speedy approvals,” Sanchez said. 

The FDA announced stricter protocols when it came to approving an emergency coronavirus vaccine, and FDA commissioner Dr. Stephen Hahn made a promise that the “FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families.”

“FDA will not authorize or approve any Covid-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness,” Hahn told the Senate Health Committee. “Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes, and science will guide our decisions.”

He added: “FDA will not permit any pressure from anyone to change that.”

However, during the news conference at the White House on Wednesday, Trump erroneously cast any delay in releasing a COVID-19 vaccine to the public as “a political move.”

“That has to be approved by the White House. We may or may not approve it,” Trump said. “Why would they be adding great length to the process?”

Sanchez told Business Insider that he is not aware of whether the president is able to make such a move. But said that considering that the FDA is an executive agency, he supposed “there could be a situation where President Trump revoked this delegation and makes a decision directly,” which “would totally upend not only the FDA structure but how we think of executive agencies generally.”

“FDA relies on public trust, and the FDA staff I have worked with and befriended in over a decade of practice understand this keenly,” Sanchez said. “It is terrible to think of FDA losing that trust.”

He added that the independence of the agency is critical so that people can remain confident in the vaccine and the overall quality of the agency.

Sanchez drew on the contentious reputation of the Centers for Disease Control and Prevention, which has recently been embroiled in public disputes with the Trump administration over health guidelines and recommendations amid the coronavirus pandemic.

“There’s this core public trust, and we have that in the FDA. Part of that core trust is that its independent, and that independence is rooted in science and public health, protecting public health through good science,” he said, adding that he thinks the CDC has failed to establish such independence and reliance on “pure science.”

Sanchez highlighted that the FDA work with hydroxychloroquine, and how despite political pressure they still based their rulings on scientific information. 

He explained that FDA approval for vaccines in many cases gets more scrutiny than other drugs because they affect essentially the entire population. He said the organization goes through multiple steps from clinical work in several different phases to do a risk-benefit analysis and evaluate the safety and efficacy of a vaccine.

“Normally that process would take years and we’re talking about it in a non-pandemic, a non-priority drug. It’s a very long process to go through,” Sanchez said. “Obviously, we’re trying to truncate that process in the interest of public health, but not trying to take shortcuts in a way that introduce new risk or upset that balance of risk and benefit.”

He added, however, that the political commentary and focus on a vaccine, including claims by Trump to have one ready before the election, has added some degree of pressure to researchers, who would normally do their work without any rush.

“Now we have the management themselves receiving political pressure that then kind of continues to push down. So I think that’s principally what we’ve seen or can see happen is ordinary reviewers being told to hurry their work or to produce a result more quickly,” he said. “And so I think that’s part of that public trust element that we’ve got to make sure that they continue to do the work aware of the pandemic and the public health need for this, but not making a decision or rushing their work to make mistakes.”