HHS Power Grab is ‘Distraction to FDA:” Gottlieb
Former FDA commissioner Scott Gottlieb says a recent move by HHS secretary Alex Azar to redirect his authority to prevent FDA and other health agencies from introducing any new rules on their own is a “distraction to FDA at the time that they should be focused on the Covid response.” Appearing on CBS’ Face the Nation 9/20 (see transcript), Gottlieb said the timing of this HHS action makes no sense. “I don’t believe in the underlying basis of what they did,” he told CBS host Margaret Brennan. “But the timing of this is just really poor right now because it’s going to distract the agency. And frankly, it creates headlines that could leave the perception that the agency is being bullied.”
Gottlieb's comments came in reaction to a New York Times report about the Azar memo. Azar’s chief of staff Brian Harrison defended the move as a “housekeeping action, which should have no operational impact because all rules already required departmental clearance... Assertions that this was aimed at any specific division or leader are dishonest or uninformed.”
Azar’s rulemaking assertion could call into question all the rules that were implemented where lower level agency staff were delegated the authority to sign those rules, according to Gottlieb. “And in fact, on my second to last day on the job, I recodified the tobacco deeming regulation because I was concerned that they could take this kind of a step and then use it as a basis to call into legitimacy the codification of that deeming rule,” he explained. “So I recodified it myself, even though it was put in place under the Obama administration.” He predicted that certain groups will legally challenge the tobacco deeming rule and possibly other rulemaking by alleging that that rule was inappropriately implemented because the authority to sign that rule was delegated to a lower level career official inside the agency. “And I think if the basis for why the secretary did this is because he thinks the past delegations were inappropriate, that potentially could create another avenue to have legal challenges,” Gottlieb said.
Asked by Brennan whether there is any scenario where president Trump could legally override FDA and authorize a vaccine, Gottlieb said he doesn't see a scenario where this can happen. “This isn't like posting new guidelines on CDC’s Web site in the middle of the night,” he said. “In order to issue an authorization, an emergency use authorization or an approval, the only people capable of actually drafting that package are the people at FDA. And they’re not going to be forced to do it unless they scientifically believe in it. I know the folks who are involved in this process, the career professionals who are engaged in this process, and they’re not going to be easily cowed.”
Gottlieb also said he believed that no vaccine manufacturer would be willing to commercialize a vaccine based on a politically influenced authorization or approval. “The vaccine doesn't just ship into the supply chain,” he said. “And I do not believe any manufacturer is going to commercialize a vaccine based on an authorization or approval that doesn't have the consent and the agreement and the involvement of the career professionals inside the FDA. I just don't see that happening. So this isn’t something that I think is easily subject to outside influences.”
On Sunday and presumably in reaction to news about the memo, HHS posted a statement to clarify its action.