Category: Off-Label Marketing

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

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The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

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FDA’s Revocation of the Hydroxychloroquine and Chloroquine EUA May Test the Limits of PREP Act Immunity

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On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the Strategic National Stockpile. (https://www.fda.gov/media/138945/download) The FDA concluded, based on clinical trial data and the continuing failure of treatment guidelines to support use of CQ or HCQ to treat patients with COVID-19, that “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”

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FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine

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The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.

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