Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency.” The FDA stated that it was issuing this guidance to address questions it has received related to the distribution of drug samples during the COVID-19 public health emergency (PHE) under the Prescription Drug Marketing Act of 1987 (PDMA). This guidance is critical because life sciences companies have adopted a variety of methods to distribute drug samples as part of their marketing programs in response to COVID-19, rather than traditional methods that include deliveries by sales representatives.
In accordance with this guidance, life sciences companies that have engaged mail and common carriers may permit alternate methods of verifying the delivery of drug samples that normally require an adult signature. The FDA stated that it “does not intend to take action against a manufacturer or authorized distributor of record that accepts alternate ways of verifying delivery and receipt of drug samples instead of obtaining the signature of the person acknowledging delivery, provided, however, the receipt obtained by the manufacturer or authorized distributor of record complies with all other receipt requirements in PDMA and 21 CFR 203.30(c).”
Additionally, the FDA is permitting alternate places to deliver drug samples during the COVID-19 PHE. The PDMA normally requires drug samples be sent to the requesting health care professional (HCP) or, at the written request of such HCP, to the pharmacy of a hospital or other health care entity. However, due to restrictions in connection with COVID-19, the FDA does not intend to take action against a manufacturer or authorized distributor of record that delivers drug samples by mail or common carrier directly to:
- A patient’s home, provided that: (i) the HCP has submitted an executed written request to the manufacturer or authorized distributor that identifies the patient of the HCP who has been designated to accept the drug sample delivery; (ii) the receipt of the drug sample is documented in accordance with PDMA requirements for drug samples delivered by mail or common carrier; and (iii) the manufacturer or authorized distributor complies with PDMA recordkeeping and other applicable requirements.
- An HCP’s home, provided that the HCP submits an executed written request to the manufacturer or authorized distributor for the delivery of the drug samples to their home being used as an office, and all other applicable provisions in part 203 are met. Notably, the FDA confirmed that it does not anticipate changing this policy following termination of the COVID-19 PHE.
It is critical to note that drug samples cannot be distributed to a retail pharmacy. The FDA confirmed that it does not intend to change this policy in response to the COVID-19 PHE.
Life sciences companies and their authorized distributors should carefully review this temporary FDA guidance to ensure compliance with PDMA requirements during the COVID-19 PHE. For more information, contact the author or your Dinsmore attorney.