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The agency published guidance to clarify its enforcement of distribution of drug samples for drug marketing during COVID-19.
On June 8, 2020, FDA published a guidance document that answers questions about FDA’s enforcement of Prescription Drug Marketing Act of 1987 (PDMA) requirements during the COVID-19 pandemic, specifically related to the distribution of drug samples. PDMA, which is part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), established requirements for the distribution of prescription drug samples by mail or common carrier and requires licensed practitioners to request drug samples in writing. It also mandates requirements for storage, handling, and recordkeeping for drug samples.
According to the guidance document, because of the COVID-19 public health emergency (PHE), manufacturers that use drug samples in their marketing programs are relying more on mail and common carriers instead of these samples being provided by sales representatives. The guidance details the agency’s policy for “the collection of physical signatures upon delivery of drug samples and the ability of licensed healthcare providers to request that drug samples be delivered to various locations during the COVID-19 PHE.” The document addresses delivery to a patient’s home, delivery to licensed practitioners’ homes, and delivery to pharmacies. According to a statement by FDA, the agency “does not intend to object to the delivery of prescription drug samples to patients’ homes if requested by their licensed health care professional ….”