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In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The announcement is an abrupt—but not unexpected—reversal from a previously issued controversial decision by the Trump administration’s HHS to end the Unapproved Drugs Initiative in November 2020. The reinstatement means that companies that market unapproved drugs should reassess their risk under FDA’s preexisting enforcement priorities.

In its May 27 notice, HHS stated that the November 2020 announcement by former HHS Secretary Alex Azar terminating FDA’s enforcement program against unapproved marketed drugs was “legally and factually inaccurate” and issued without consultation with FDA. “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, among other legal authorities, and is not supported by the facts,” the Federal Register notice states. “In addition, the [November 2020] HHS notice could result in significant harm to public health by suggesting that unsafe or ineffective drugs could circumvent the drug approval process.”

Generally, under the FFDCA, new drugs may not be introduced into interstate commerce unless FDA has approved a drug application based on proof of safety and effectiveness. However, following the 1938 and 1962 amendments to the FFDCA that created the safety and efficacy requirements for drugs, some existing drugs were permitted to be manufactured and sold without approval under the FFDCA’s grandfather clauses. Through a compliance policy guide that was amended over the years (CPG 440.100), FDA encouraged companies to seek New Drug Applications (NDAs) for unapproved marketed drugs and articulated the agency’s risk-based enforcement strategy.

With respect to grandfathered drugs, FDA explained that to qualify for an exemption from the agency’s new drug approval requirement, the drug product, as formulated, would have to have been marketed prior to either 1938 or 1962. Specifically, FDA stated that the grandfather clauses “have been construed very narrowly by the courts. FDA believes that there are very few drugs on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population.” When ending the Unapproved Drugs Initiative, however, the Trump administration implied that the agency had misinterpreted the definition of what constitutes a new drug, and, as a result, required more products to obtain FDA approval for marketing than what the statute contemplated.

Looking forward, FDA stated that it “plans to issue guidance on [its enforcement authority over unapproved drugs] consistent with good guidance practices.” Pending the issuance of new guidance, the agency “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.”

While the reinstatement of FDA’s Unapproved Drugs Initiative will likely impact only a small number of products on the market, it is, nonetheless, remarkable because it signals a realignment of FDA and HHS decisionmaking around enforcement policies.