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# FDA Reverses Trump HHS Unapproved Drug Initiative Notice
- URL: https://www.fdaweb.com/fda-reverses-trump-hhs-unapproved-drug-initiative-notice/
- Published: 2021-05-26T12:00:00.000Z
- Updated: 2026-09-14T17:00:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149407

FDA says it is withdrawing a “legally and factually inaccurate notice and request for information” that the Trump administration HHS published 11/25/20 to terminate FDA’s unapproved drug initiative (UDI). A sharply worded *Federal Register* [notice](https://public-inspection.federalregister.gov/2021-11257.pdf?ref=fdaweb.com) signed by FDA acting commissioner **Janet Woodcock** says the HHS notice contained multiple legal and factual inaccuracies, requiring that it be withdrawn.

The notice says that central to the legal and factual inaccuracies in the [original notice](https://www.fdaweb.com/hhs-moves-to-terminate-fda-unapproved-drugs-initiative/) is the then-HHS misinterpretation of the term “new drug.” It says that for decades FDA has interpreted the word “drug” in the term “new drug” to refer to an entire drug product and not just its active ingredient, and noted that courts have consistently accepted that interpretation.

It also discusses FDA’s UDI, the 45 initiative actions the agency has taken since 2006 that it says led to hundreds of potentially unsafe drugs being voluntarily removed from the market, and a 2006 compliance policy guide on marketing unapproved drugs that was updated in 2011.

The current notice says the HHS 2020 notice tried to terminate the UDI by withdrawing the compliance policy guidance. The 2020 notice also requested information regarding the definition of “new drug” and whether certain drugs might be grandfathered or qualify as generally recognized as safe and effective (GRASE) and thus not subject to the new drug approval requirement.

“We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the HHS notice,” the new notice says. It notes that the law provides that the HHS secretary would take such actions through the FDA commissioner.

After describing several legal issues with the original HHS notice and multiple misstatements and flawed facts, Woodcock says the HHS notice does not accurately reflect the department’s or FDA’s thinking because it is inconsistent with the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA regulations, and judicial precedent and is not supported by the facts. She also says the notice could result in significant harm to public health by suggesting that unsafe or ineffective drugs could circumvent the drug approval process.

“We recognize that the withdrawal of the compliance policy guide may have created confusion for the public, including regulated industry, as to how FDA intends to prioritize its enforcement resources in this area,” the new notice says. “FDA therefore plans to issue guidance on this topic consistent with good guidance practices. The guidance will provide appropriate updates regarding FDA’s enforcement policies for marketed unapproved new drugs. In the interim, before such guidance is issued, FDA will continue to exercise its existing general approach to prioritizing regulatory and enforcement action, which involves risk-based prioritization in light of all the facts of a given circumstance. Risk-based enforcement best supports FDA’s public health priorities.

Woodcock also points out that FDA’s long-standing interpretation of the terms “new drug,” “grandfathered,” and “GRASE” is unchanged and the 2020 notice did not affect the requirements that apply to new drugs under the laws FDA administers. “The HHS notice did not, and legally could not, provide a new pathway for the legal marketing of unapproved new drugs,” she states. “Neither HHS nor FDA has the authority to exempt a product or a class of products that are new drugs under the FFDCA from the new drug approval requirements of the FFDCA.”