Loyola University Chicago, School of Jaw, JD 2022
The Food and Drug Administration (“FDA”) is one regulatory agency that has been on the forefront of the American fight against COVID-19. Historically, the agency has been highly respected for its success in apolitical operation despite its mission of (1) protecting the public health and (2) innovating in the development of medical products. One of its most important tools in the face of a public health crisis is the once obscure regulatory mechanism called the Emergency Use Authorization (“EUA”). But as public trust in the FDA falters, Americans are surely wondering how effective a protective measure can be when it seems to be used as political ammo.
The FDA’s place in all of this
Organizationally, the FDA is an executive agency organized under the Department of Health and Human Services (“HHS”). Especially for such a robust and powerful agency, this hierarchical structure poses a unique, but until now, relatively unprovoked opportunity for tension between the Commissioner of the FDA and the Secretary of HHS. However, these are indeed unprecedented times, and even the FDA has become politicized.
What exactly is an Emergency Use Authorization (“EUA”)?
An EUA is a mechanism to strengthen public health protections in the face of a public health crisis, like the current COVID-19 pandemic. As amended by Project Bioshield Act of 2004, Section 564 of the Food, Drug & Cosmetics Act allows the FDA commissioner to issue an EUA to address certain types of emergencies. This regulatory tool allows the FDA to authorize the use of an unapproved medical product or of an approved medical product for unapproved uses when there are no adequate or approved alternatives.
Unlike typical FDA authorizations, the EUA approval process allows the FDA to use available information to balance risks of the unproven products with any known benefits. An EUA can only be granted in a declared state of national emergency and is not a substitute for a standard approval. Although the FDA doesn’t proscribe a timeline for typical vaccine development, EUA approval is intentionally expedited in comparison.
On December 11, 2020, the FDA’s advisory committee recommended the Pfizer vaccine be granted EUA status. The FDA has only granted an EUA for a vaccine once before for Anthrax vaccine Adsorbed. Ultimately, it was revoked.
Remember hydrochloride? Yeah, that was an EUA…
In their very nature, EUAs are subject to skepticism. Paired with errant statements from a rhetoric-heavy president, they stand to lose all credibility. While the FDA has granted EUAs in past disease outbreaks like H1NI flu in 2009 and Zika in 2016, COVID-19 response has generated an unprecedented 300 EUAs since February 2020.
One now infamous product, antimalarial drug hydroxychloroquine, received an EUA which was revoked shortly thereafter. If not for then-President Trump’s wholehearted endorsement, the EUA may have come and gone with relatively little attention. But instead, medical experts and the public alike condemned the apparent politicization of the drug.
The FDA has since received criticism from the White House and directly from former President Trump through Twitter (although the posts have since been redacted). Shortly thereafter, the Trump administration resisted the FDAs announcement of revamped vaccine authorization guidance concurrent with a push from the Trump Administration to get a vaccine approved before Election Day. The problematic political pressure exerted on the FDA’s decision making process regarding COVID drugs had raised concerns about the agency’s ability to operate impartially.
Great, there is a vaccine. Will it work?
Creation of a vaccine is only half the battle. It’s not easy to get it to where it needs to go, and at the (cold – very cold) temperatures it needs to stay at. Cities have unintentionally mis-stepped in finding adequate partners for distribution. And historically, people are really bad at following up for a second dose of a two-part vaccine.
There is a lesson to be learned from all of this. Clearly, the FDA has limited safeguards against a President or HHS secretary from meddling for political influence. To prevent this from happening again, Congress could potentially insulate the FDA similar to the structures of agencies like the Federal Trade Commission. For example, the FDA could be moved from under the watchful gaze of the HHS. Alternatively, the FDA commissioner could only be replaced during their terms “for cause” in efforts to shield them from the whims of the Commander-In-Chief.
Hopefully Americans everywhere can contemplate this over a cocktail of fully approved COVID-19 vaccines in the coming months.