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Enforcement Edge
July 16, 2020

FDA Relaxes Certain Drug Sample Distribution Rules During COVID-19 Pandemic

Enforcement Edge: Shining Light on Government Enforcement

Last month, FDA issued new guidance that, during the current COVID-19 public health emergency, the agency will not enforce some of the delivery requirements of the Prescription Drug Marketing Act of 1987 (PDMA). The PDMA governs the distribution of prescription drug samples and imposes criminal penalties for non-compliance. The US Department of Health and Human Services' Office of Inspector General also looks to PDMA non-compliance as a potential red flag for other compliance violations concerning free drug samples, such as fraudulent billing and unlawful resale or diversion. FDA's new guidance—"Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency"—recognizes that certain PDMA delivery requirements might currently be impractical or jeopardize the health and safety of those involved in drug sample delivery and receipt. Most notably, the FDA has temporarily blessed home deliveries of drug samples and suspended the receipt-signature requirement for the duration of the public health emergency. These actions are significant (albeit temporary) shifts from pre-pandemic agency practices.

Ordinarily, the PDMA and its regulations require that drug samples delivered by mail or common carrier must go only to (1) a licensed prescriber or (2) a healthcare entity's pharmacy (i.e., not a retail pharmacy). The person receiving a drug sample must also complete and sign a written receipt, which must be returned to the manufacturer or distributor of record.

FDA's new enforcement policy explains that because the PDMA and related regulations do not specify where a licensed prescriber must receive drug samples, the FDA is temporarily permitting the delivery of drug samples directly to a prescriber's home. Notably, FDA has stated that it does not anticipate changing its legal interpretation that permits deliveries to prescribers' homes after the COVID-19 public health emergency, and that it will "address this issue in future guidance with any appropriate changes based on comments received on this guidance and the Agency's experience with implementation." FDA's new enforcement policy also temporarily permits the delivery of drug samples directly to patients during the public health emergency.

The new policy also provides that FDA will not enforce the requirement of a signed receipt for the duration of the public health emergency. Rather, FDA explains that manufacturers and authorized distributors can employ alternatives for verifying sample delivery and receipt, as long as the delivery receipt's contents satisfy all other applicable requirements set forth in 21 C.F.R. § 203.30(c) (e.g., listing the quantity and strength of the delivered drug sample). Despite FDA's actions to relax various PDMA requirements during the public health emergency, the agency has reiterated that drug samples still may not be distributed to retail pharmacies.

As pharmaceutical companies consider how to adapt and invest in new distribution strategies, vendors, and business rules, they should give careful consideration to the opportunities created by the FDA policy—while also recognizing its time-limited nature.

© Arnold & Porter Kaye Scholer LLP 2020 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.