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Who Will Approve a COVID Vaccine in the US?

Summary

As life sciences companies sprint toward COVID-19 vaccines and therapies, the discussion below considers who has the authority to make the call on their availability at the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS).

Operation Warp Speed, a joint public–private task force tasked with expediting COVID-19 countermeasures, recently expressed growing optimism of meeting its goal of facilitating delivery of “300 million doses of a safe, effective vaccine by January 2021.” HHS Deputy Chief of Staff for Policy Paul Mango said:

“We have no insight into the data until the [Data Safety Monitoring Board] (DSMB) says we can look at it. They could come back and say, ‘This is not a good vaccine.’ They could come back before we even have 30,000 folks enrolled and say, ‘We’ve seen enough. This looks great. Pass it on to the [FDA].’ We just don’t know.”

And that is true in practice. The FDA’s mission includes “protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, [and] biological products,” among other things. The FDA approves New Drug Applications (NDAs), Biologics License Applications (BLAs), and—as we have seen recently during the COVID-19 national public health emergency—Emergency Use Authorizations (EUAs).

The FDA takes a considered, risk-balancing approach in the matter of drugs (21 United States Code (USC) § 355) and biologics (42 USC § 262, further subsuming the requirements of the Food, Drug, and Cosmetic [FD&C] Act), requiring substantial clinical evidence from sponsors demonstrating safety and efficacy when administered to a given population for a given clinical indication. For an EUA (under 21 USC § 360bbb-3)—owing to the urgency of a public health emergency—the FDA typically considers whether it is “reasonable to believe” that the medical product under consideration provides a greater clinical benefit than the risks associated with its use, based on the available “totality of scientific evidence” (21 USC § 360bbb-3(c)(2)).

The FDA determines the fate of any medical product that a sponsor seeks to introduce into interstate commerce. But that authority is not conferred on the FDA directly in either the FD&C or Public Health Service Acts. Rather, as a textual matter of statute and regulation, Congress has conferred the authority to approve drugs and biologics (which includes vaccines, at 42 USC § 262(i)(1)) and to authorize the same under a public health emergency, to the Secretary of HHS. While it is easy to think of the 2 as distinct entities, much of the FDA’s regulatory authority flows from what is delegated to it by HHS through the Secretary, as conferred upon the department by Congress in statutory law.

For NDAs, “Any person may file with the Secretary an application with respect to any drug” (emphasis added), the Secretary being defined elsewhere in statute as “the Secretary of Health and Human Services” (21 USC § 321(d)). For BLAs, “The Secretary shall approve a biologics license application” (emphasis added), the Secretary being “[u]nless the context otherwise requires… the Secretary of Health and Human Services” (21 USC § 201(c)). And for EUAs, “the Secretary may authorize the introduction into interstate commerce […] of a drug, device, or biological product intended for use in an actual or potential emergency” (emphasis added, 21 USC § 360bbb-3(a)(1))’ the Secretary likewise is the HHS Secretary (21 USC § 321(d)).

The HHS Secretary has typically passed these authorities down to the FDA Commissioner through memorialized Delegations of Authority (such as the 2016 Staff Manual Guide 1410.10 – Delegations of Authority to the Commissioner of Food and Drugs) who, in turn, may delegate further down to center directors or office directors (e.g., the 2012 Staff Manual Guide 1410.204 – Issuance and Revocations of Licenses for the Propagation or Manufacture and Preparation of Biological Products). And while much authority has been delegated to the FDA for the purposes of drug approval, biologics licensing, and emergency use authorization, the power remains with the Secretary as a matter of statute. If the HHS Secretary were to ever have a difference of opinion with an FDA decision in one of those matters, it is possible that the HHS Secretary could exercise that Congressionally conferred authority personally, consistent with other provisions of law. In light of the unique challenges created by COVID-19, this may be important to consider as part of the current public health emergency.

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