7 former FDA commissioners say Trump is undermining the agency's credibility
Seven former FDA commissioners accused the Trump administration of "undermining the credibility" of the agency in a Washington Post op-ed published Tuesday.
Why it matters: The editorial comes amid fears that the Trump administration has politicized the coronavirus response and is seeking expedited approval and distribution of a possible vaccine.
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."
- Gottlieb and McClellan sit on the boards of Pfizer and Johnson & Johnson, respectively, both of which are in the process of developing COVID-19 vaccines. Gottlieb, who led the agency for two years under Trump, has become a consistent voice critiquing the U.S. response to the virus.
- Kessler is an adviser for the Biden campaign.
What they're saying: "[A] safe and effective vaccine will not be enough; people will also have to choose to take it. This depends on widespread confidence that the vaccine approval was based on sound science and not politics."
- "[T]he perception of political influence matters."
- "With more than 750 Americans on average dying a day from covid-19, the FDA must be supported to play its unique and essential role. Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests. Political intrusion only prolongs the pandemic and erodes our public health institutions."
Details: The commissioners cited Trump's comment implying he may reject tougher standards for a coronavirus vaccine and a memo in which Health and Human Services Secretary Alex Azar revoked the FDA's authority to issue new rules on foods, medicines and medical equipment, including vaccines.
- "These actions are eroding the public’s confidence," the commissioners wrote. "This month, an Axios-Ipsos poll found that 42 percent of Americans lacked trust in FDA decision-making."
Yes, but: "Despite recent political actions, we continue to have confidence in the integrity and high-quality scientific work of FDA staff," the commissioners 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."