On October 6, 2020, FDA Commissioner Stephen Hahn, M.D., stiffened his spine against the White House and issued long-awaited guidance for developers of COVID-19 vaccines. At the heart of the guidance are strict new requirements of a review by a panel of experts and asking drug makers to monitor patients for two months after final dose of the vaccines. The White House opposed those requirements.
The credibility of the Food and Drug Administration and its commissioner are hanging on a razor’s edge as drug makers race to develop a vaccine for COVID-19 that has already killed over 210,000 Americans. Will the public believe the vaccines are safe and effective?
Previous Commissioners Accuse Trump of Undermining Credibility
Previous White House efforts to influence the FDA’s approval process of a COVID-19 vaccine so alarmed seven former FDA Commissioners that they penned an op-ed in the Washington Post on September 29, 2020, accusing the Trump administration of “undermining the credibility” of the agency.
This came after the president tweeted on August 22, 2020, that, “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed and saving lives!”
The former commissioners Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach, cautioned the White House against taking “the unprecedented step of trying to tip the scales on how safety and benefits [of the vaccine] will be judged.”
They noted a recent Axios-Ipsos poll that found that 42% of Americans lacked trust in FDA decision-making.
Hahn Accused of “Political Hit Job”
Perhaps with the unprecedented and public support of the former commissioners, Commissioner Hahn didn’t cave to the pressure, causing the president to again accuse Hahn and the agency of carrying out a “political hit job” against him. The president tweeted the accusation while being treated with, among other things, steroids, for the COVID-19 virus.
We’ll give the final word on the agency’s credibility to the former commissioners, who wrote, “The FDA has already effectively communicated its strict standard for evidence from these trials to the manufacturers, despite comments from the White House. The health professionals whom people still trust won’t recommend a vaccine that hasn’t met the FDA’s standards. Drug makers have also pledged to use the FDA’s scientific standards.”
On November 3, American citizens will have their say over whom to trust for evidence and science. After that they will have to decide if they trust the vaccines.
