On May 26, the Food and Drug Administration (FDA) reversed a Trump Administration policy that revoked the agency’s longstanding Unapproved Drugs Initiative (UDI).
On November 15, 2020, then HHS Secretary Alex Azar issued a notice and a request for information entitled “Termination of the Food and Drug Administration’s Unapproved Drugs Initiative; Request for Information Regarding Drugs Potentially Generally Recognized as Safe and Effective” 85 Fed. Reg. 75331 (Nov. 25, 2020) which withdrew FDA’s Marketed Unapproved Drugs Compliance Policy Guidance (CPG). The CPG had long set out how FDA prioritized enforcement against drugs that were not subject to approved drug applications and were being marketed unlawfully in violation of the Federal Food, Drug, and Cosmetic Act (FDC Act). The notice also sought information from the public on drugs that could be deemed “grandfathered” and therefore exempt from the safety and/or efficacy requirements of the FDC Act or that might otherwise be considered generally recognized as safe and effective and would not have to be subject to an approved drug application. The CPG was part of the UDI launched in 2006 to reduce the number of drugs that were being marketed without approved applications and demonstrations of safety and efficacy. Under the UDI, FDA prioritized for enforcement those unapproved drugs most likely to pose risks to human health and took action against hundreds of products. The Trump Administration revoked the UDI, arguing that it resulted in high drug prices and drug shortages, provided limited new clinical data evidence for older drugs, and was improperly initiated through guidance instead of notice-and-comment rulemaking.
In FDA’s withdrawal notice, Acting Commissioner Janet Woodcock noted that the agency found no evidence that the Trump Administration first consulted with, involved, or notified FDA before issuing the notice, in violation of the FDC Act. Additionally, the November 2020 notice made several legal and factual misinterpretations when terminating UDI. Notably, the Trump Administration’s notice misinterpreted the well-established, legal definition of a “new drug.”
The notice also challenged the Trump Administration’s claim that UDI resulted in higher drug prices and highlighted the harm repealing UDI would have had on public health by suggesting that unsafe or ineffective drugs could have become exempt from the drug approval process. Since 2006, FDA initiated 45 actions that led to the removal of hundreds of potentially unsafe drugs from the market for safety concerns including serious adverse events, inadequate labeling, or lack of compliance with current good manufacturing practices. Of those 45 actions, 17 were taken as a result of informal requests, 15 were taken as a result of warning letters, and 13 were taken due to Federal Register notices announcing FDA would take enforcement action.
FDA also opined that UDI was not a new policy that should have been adopted through notice-and-comment rulemaking but instead described FDA’s ability to communicate enforcement priorities through existing legal authorities. According to the notice, communicating enforcement policies through guidance rather than legislative rules is consistent with the Administrative Procedure Act and FDA’s good guidance practices.
The Biden Administration has reversed several similar pronouncements from the last days of the Trump Administration including one that was purportedly intended to increase drug review timeline transparency and another which exempted seven types of surgical and patient examination gloves and proposed to permanently exempt more than 80 Class II devices from premarket notification requirements. Notably, the Biden Administration delayed implementation of the Trump administration’s “SUNSET” rule due to ongoing litigation, which would require that regulations be automatically sunset and be rescinded unless agencies, subject to certain exceptions, perform retrospective reviews to assess the economic impact of a regulation’s requirements consistent with the Regulatory Flexibility Act ten years after each regulation is issued.