In response to the ongoing COVID-19 public health emergency, the United States Food and Drug Administration (FDA) issued a temporary policy related to the distribution of drug samples. Recognizing the unique challenges currently facing manufacturers that distribute drug samples as part of marketing efforts and the healthcare providers requesting those samples for patients, the FDA is temporarily easing certain requirements of the Prescription Drug Marketing Act (PDMA).

Physical Collection of Signatures Upon Receipt of Drug Samples

The PDMA and its implementing regulations allow manufacturers (or their authorized distributors of record) to distribute drug samples to a practitioner licensed to prescribe the drug or, at the practitioner's written request, to the pharmacy of a hospital or other healthcare entity, through mail or common carrier. 21 U.S.C. § 353(d)(2)(A) and 21 C.F.R. 203.30(a). When those drug samples are received, the requesting practitioner must execute a written receipt signed by the practitioner or the practitioner's designee. 21 C.F.R. 203.30(c)(1). When drug samples are delivered to the pharmacy of a hospital or other healthcare entity, the receipt must contain the signature of the person acknowledging delivery. 21 C.F.R. 203.30(c)(2). The FDA's temporary policy acknowledges that in response to the COVID-19 public health emergency, mail and common carriers may be using methods other than signatures to verify receipt of deliveries. As a result, the policy indicates that during the public health emergency, the FDA does not intend to take action against manufacturers or authorized distributors that accept alternate methods of verifying delivery of drug samples, provided that all other receipt requirements are met.

Place of Delivery of Prescription Drug Samples

Recognizing the impact that state and local stay-at-home orders and social distancing recommendations have had on the ways in which practitioners provide care and consultation, the FDA's temporary policy also addresses requirements regarding the place of delivery of drug samples.

Patient's Home

Although many practitioners are not currently meeting face-to-face with patients during the COVID-19 public health emergency, FDA acknowledges that those practitioners may still wish to request drug samples for patients. In response, the temporary policy states that FDA does not intend to take action against a manufacturer or authorized distributor that delivers drug samples by main or common carrier directly to an identified patient's home, provided that the following requirements are met:

  1. The written request for samples must be executed by the licensed practitioner, in accordance with regulatory requirements, 21 C.F.R. 203.30(a)(1), for an identified patient designated to accept the delivery of the drug samples as the licensed practitioner's designee;
  2. The receipt of the drug samples must be documented in accordance with regulatory requirements, 21 C.F.R. 203.30(a)(3) and (4); and
  3. The manufacturer or authorized distributor must meet recordkeeping and other applicable requirements under PDMA and FDA regulations.

Practitioner's Home

Additionally, the FDA's temporary policy recognizes that many practitioners may currently be practicing telemedicine from their homes, and notes that neither the PDMA nor its implementing regulations prohibit the delivery of drug samples to a licensed practitioner's home, provided that applicable regulatory requirements are met. Notably, the temporary policy indicates that this interpretation of PDMA and related regulations "reflects FDA's current thinking and is not anticipated to change following termination of the COVID-19 [public health emergency]." The policy indicates that following the termination of the public health emergency, the FDA will address this issue with further guidance and with any appropriate changes based on comments received and the agency's experience with implementation.

Retail Pharmacy

Finally, the FDA reiterated that the PDMA and implementing regulations do not allow drug samples to be distributed to a retail pharmacy. 21 U.S.C. 353(d)(1) and 21 C.F.R. 203.30(a). The temporary policy does not change these requirements during the COVID-19 public health emergency.

The FDA's temporary policy was implemented immediately without prior public comment, although it remains subject to comment in accordance with the agency's good guidance practices. Like similar measures taken by the FDA and other government agencies, this policy is a temporary response to the COVID-19 public health emergency. Manufacturers, distributors and practitioners should ensure that they continue to follow standard practices to fulfill other requirements of the PDMA and its implementing regulations.

For More Information

If you have any questions about this Alert, please contact Frederick R. Ball, Erin M. Duffy, Kristine Murphy Gallagher, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Health Law Practice Group, any member of the COVID-19 Strategy Team or the attorney in the firm with whom you are regularly in contact. 

Originally published June 18, 2020

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.