On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) Marketed Unapproved Drugs Initiative (UDI). However, on May 27, HHS and FDA jointly published a notice in the Federal Register withdrawing the termination notice.
Withdrawal of Termination Notice
The withdrawal describes the termination notice as “legally and factually inaccurate,” including with regard to misinterpreting the statutory definition of “new drug,” among “other misstatements.” In addition, the withdrawal asserts that HHS exceeded its authority and deviated from the required administrative procedure in unilaterally issuing the notice without consulting with FDA.
The withdrawal notice states that FDA intends to issue new guidance on its enforcement authority over unapproved new drugs, and that in the interim, FDA will continue to exercise its risk-based approach to prioritization of enforcement action against unapproved drugs.
Background on the UDI
To end the UDI program, HHS had announced last year that it was withdrawing FDA’s Compliance Policy Guide (CPG), “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs,” as well as all “compliance manuals, website statements and other informal issuances” relating to the policy. Those documents describe how FDA intends to prioritize regulatory action under its existing enforcement authority regarding currently marketed unapproved new drugs, including that FDA generally intended to apply a risk-based approach.
The withdrawal notice touts how the UDI yielded 45 enforcement actions since 2006, which “have led to hundreds of potentially unsafe drugs being voluntarily removed from the market, including several drugs with significant safety concerns.” The withdrawal notice specifically cites how these compliance actions have spurred manufacturers to seek and obtain FDA approval of carbinoxamine and quinine sulfate drug products with proper labeling for safe and effective use. In addition, FDA takes that position that FDA-approval of drugs, including with regard to the chemistry and manufacturing, “helps ensure the drug is produced reliably and consistently.”
Problems with the termination notice
The withdrawal notice states that HHS and FDA “did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA” before issuing the termination notice for the UDI program. Moreover, the withdrawal notice says, HHS failed in the termination notice to properly interpret the statutory term “new drug,” deviating from longstanding FDA interpretation and applicable judicial precedent.
The withdrawal notice also describes “other misstatements” in the termination notice, including that it erroneously described the UDI program and FDA’s CPG 440.100 guidance as a new policy that should have been adopted through notice-and-comment rulemaking. The notice also rejects as “supported by flawed facts” the arguments in the termination notice that the UDI and CPG caused increased drug prices. In the withdrawal notice, FDA takes issue with HHS’s reliance in the termination notice on an observational study limited to only 26 drugs that was not adjusted for inflation.