In response to the COVID-19 emergency, the FDA is announcing a temporary policy regarding enforcement of the requirement for drug samples.
The U.S. Food and Drug Administration (FDA) is issuing updated guidance to address questions they’ve received asking for clarification regarding their enforcement of requirements on the distribution of drug samples under the Prescription Drug Marketing Act (PDMA) of 1987 . The PDMA is part of the Federal Food, Drug, and Cosmetic Act, and the relevant implementing regulations regarding drug samples are in 21 CFR part 203 (part 203), subpart D.
The relevance of this modification affects health care providers, patients affected by COVID-19 and related conditions, and the life science companies themselves, according to information highlighted in The National Law Review.
The drug sample revisions, issued by the FDA earlier in June, affect how licensed practitioners provide care and consultation to their clients during a public health emergency. In response to the COVID-19 emergency, the FDA is announcing a temporary policy regarding enforcement of the requirement for drug samples. This policy covers samples only to be sent to the requesting healthcare practitioner licensed to prescribe the drug, or to a professional at the pharmacy of a hospital or health care entity.
Under the current FDA guidance during the public health emergency (PHE), the FDA clarified drug samples can not be distributed to licensed retail pharmacies. That set of regulations has effectively not changed.
The revised guidance is in part due to patients meeting with their health practitioners via phone or video conference call. “The FDA understands that during the COVID-19 PHE, many licensed practitioners are not meeting face-to-face with patients, and these licensed practitioners would like to be able to request that manufacturer or authorized distributor can send drug samples directly to the identified patient’s home,” the updated guidance memo reads.
The FDA recognized that due to various statewide quarantines, the stay at home recommendations, as well as the almost universally recommended social distancing guidelines designed for the protection of both patients and healthcare providers, that the standard procedures must have exemptions.
Similarly, the FDA does not intend to take regulatory or enforcement actions against any manufacturer or authorized distributors that have been delivering drug samples by mail or common shipping carrier directly to the identified patient.