HHS Says Azar Memo Won’t Impact FDA Decisions on Drugs, Vaccines

HHS has clarified that last week’s memo from Secretary Alex Azar will in no way impact the FDA’s decisions on drugs and vaccines although former FDA officials say questions remain.

The Sept. 15 memo, which created alarm about HHS’ intentions regarding COVID-19 vaccine approvals, said that the secretary has the authority to sign new rules on regulating drugs, medical devices and other products overseen by HHS agencies. It’s an authority he already had though in the past his sign-off on rules was more of a formality than standard practice.

Former FDA officials say they are puzzled by the timing of the memo, given the intense scrutiny over whether the FDA is being pressured by the Trump administration to approve a vaccine before the Nov. 3 presidential election.

Former HHS General Counsel William Schultz noted that it was always formal practice for FDA rules to go through HHS and the White House, but said he was “baffled” at why Azar would issue the memo 45 days before the election.

Schultz said that HHS now requiring Azar’s signature on rules appeared to be more “symbolic” than a need to establish authority, adding that the memo raises more questions than it answers.

Peter Pitts, a former FDA associate commissioner, said HHS was smart to clarify that the memo laying out that the secretary’s sign-off on FDA rules will not impact the agency’s decisions on drug approvals. However, he said he doesn’t understand why the secretary’s signature is now needed since, in his experience, the agency had always briefed HHS on any important rule changes.

The memo reflects “very bad timing and very tone-deaf communications,” Pitts said, adding that he believes the pandemic has allowed the public to “magnify issues that aren’t really issues.”

Other former FDA officials, however, including former commissioner Scott Gottlieb, have raised alarms about the memo, describing it as “the wrong move at the wrong time” and saying it suggests the FDA’s independence may be under threat (DID, Sept. 21).

In a clarification of the memo, HHS explained that it had been working to determine who had authority to sign legally binding rules, since some had been challenged on the grounds that they were signed by people who did not actually have rulemaking power. It said the memo was not specifically targeted at the FDA and that adding Azar’s signature does not mean that any agency decisions will be subject to any additional reviews.

“You mean he just did it so that his signature can be on it,” Schultz said. “It just doesn’t make any sense.” — Jordan Williams