Former FDA Commissioner McClellan Says FDA Can be Trusted to Resist White House Pressure

Former FDA Commissioner Mark McClellan says it’s possible that a COVID-19 vaccine will be available for some portions of the population before year’s end but that it was never realistic to expect one before the Nov. 3 presidential election.

Given the FDA’s “high bar for authorizing a vaccine, it has never been likely that a vaccine would be approved before the election,” McClellan said. “We shouldn’t use that single point in time as a yardstick to measure success.”

The bottom line, he said, is that COVID-19 vaccines are being developed at a historic pace, and if a safe and effective vaccine is approved sometime this fall or winter, it will be a monumental achievement, he testified before a House Energy and Commerce subcommittee Wednesday.

“If this process stays on track, it is possible that one or more vaccines may be authorized for initial use in certain populations before the end of the year,” he said.

McClellan said he trusts the FDA to properly regulate any COVID-19 vaccine candidates regardless of White House pressure though he was one of seven former FDA commissioners who said in a Washington Post op-ed published Wednesday that political interference is eroding the integrity of the process.

“I am confident in the path ahead for developing safe and effective vaccines — so long as FDA’s expert staff continues to guide it,” McClellan told the E&C’s oversight and investigations subcommittee.

McClellan — who served as FDA commissioner from 2002 to 2004 and is now on the board of Johnson & Johnson, which is developing a vaccine candidate — said the FDA’s long-held standards and guidance, if allowed to work unabated, can both combat the virus and reassure the public.

In the op-ed, in which he was joined by Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler and Andy von Eschenbach, the former commissioners cited the White House review of an expected FDA guidance on strengthening what’s required before an Emergency Use Authorization is issued, along with several other “actions that are eroding the public’s confidence” in the approval of a safe vaccine. The opinion piece also cited a Sept. 15 memo from HHS Secretary Alex Azar that “revoked the FDA’s authority to establish rules for food and drug safety, instead claiming that sole authority for himself,” among other concerning actions.

“At risk is the FDA’s ability to make the independent, science-based decisions that are key to combating the pandemic and so much more,” the former commissioners wrote. — Suz Redfearn