Last week, HHS Secretary Alex Azar assumed all final authority in deciding new rules regarding food, medical devices and new medications.
Mark Van Scyoc / Shutterstock
Pharmaceutical companies developing vaccines against the novel coronavirus pledged to put the integrity of the scientific process ahead of politics, but now, a political move by the Secretary of Health and Human Services has muddied the waters surrounding regulatory decisions.
Last week, HHS Secretary Alex Azar assumed all final authority in deciding new rules regarding food, medical devices and new medications, which would include any vaccine against COVID-19, which has claimed the lives of 199,000 people in the United States. First reported by The New York Times, Azar issued a memorandum Sept 15 that finalizing any new rules “is reserved to the Secretary.” At this point, it is unclear how this may affect potential approval of a vaccine for the novel coronavirus.
There have been concerns that the White House could force an Emergency Use Authorization of a vaccine candidate ahead of the Nov. 3 election in order to gain swing voters for the president’s re-election bid. Last month, President Donald Trump predicted a vaccine could be available to the public by the end of the year. There have been rumors the U.S Food and Drug Administration could grant an Emergency Use Authorization to one of the vaccine candidates being supported by Operation Warp Speed due to political pressure. Such concerns increased following the FDA’s granting of EUA for convalescent plasma following a public lambasting of the agency by the president over an earlier decision to wait for more data.
The new memo signed by Azar, a former executive at Eli Lilly, includes all 27 agencies under the HHS umbrella, but as the Times noted, the FDA puts forth a significant number of regulations than other industries, second only to the Centers for Medicare and Medicaid Services.
A spokesperson for Azar told the Times the memo was a housekeeping issue that would have no impact on how the agency deals with vaccine approvals.
“The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him. Any speculation about this memo being motivated by policy considerations is utterly misinformed. This good-government action is only prospective in effect and minimizes litigation risk for the department’s public health actions, prevents potential future abuse of authority, and is consistent with congressional intent. The memo should have no effect on operational work and does not pertain in any way to guidances or any vaccine or drug approval or authorization,” HHS said in a statement.
Azar announced the rule change not only after nine pharmaceutical companies signed the pledge to uphold scientific integrity, but also the publication of an opinion piece in USA Today authored by FDA career executives, including Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA. The career civil servants noted in their opinion piece that if the FDA loses credibility from real or perceived interference, public trust will erode and people will begin to doubt and question any recommendation made by the agency.
“The FDA is at its best when its scientific, clinical and other experts are free to do what they do best — follow the science to address the public health issues and revise policy if the understanding of the science changes,” they wrote. “When it comes to decisions to authorize or approve the products we regulate, or to take appropriate action when we uncover safety issues, we and our career staff do the best by public health when we are the decision-makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.”
Former FDA Commissioner Scott Gottlieb, who was appointed by Trump, told CBS news show Face the Nation that he did not believe Azar’s restructuring would bring forth a COVID-19 vaccine that was not ready for use in the general public. He said the only people capable of drafting a package for EUA are the staff members at the FDA and he said they are career professionals who will not be “easily cowed” into signing off on a vaccine unless they scientifically believe in its efficacy and safety. Additionally, Gottlieb noted that pharmaceutical companies will not be willing to go to market with a medication that is not ready for prime time, especially a medication that does not have the involvement of the professionals at the FDA in its approval.
During his tenure at the FDA, Gottlieb used the FDA’s guidance power and his authority as commissioner to combat vaping and also fought to prevent the consolidation of power in the hands of the HHS Secretary. He told Face the Nation that Azar’s move was unfortunate and “sends exactly the wrong message.” He said this creates an implication that the independence of the FDA is being eroded or influenced and called it a major distraction.
