The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency. The Prescription Drug Marketing Act of 1987 (PDMA) describes manufacturers’ drug sample storage, handling, and recordkeeping obligations as well as the written request and receipt requirements for prescribers.
Many manufacturers utilize their field sales representatives to deliver drug samples directly to, and collect written receipts from, prescribers at prescriber offices during sales calls. The COVID-19 crisis has disrupted field sales representatives’ ability to have face to face visits with prescribers, preventing them from delivering samples and collecting required receipts. In addition, as a result of the crisis, many prescribers are providing telehealth services from their homes, impacting prescribers’ ability to receive, store and distribute samples at their offices.
In recognition that the COVID-19 crisis has affected how prescribers see their patients, FDA’s temporary guidance explains its current position on enforcement of the policy requiring samples to be sent to the requesting prescriber or his or her designee:
- Delivery to a Patient’s Home. FDA will not take action against a manufacturer that delivers drug samples by mail or common carrier to an identified patient’s home; provided that (a) the written request by the prescriber is for an identified patient of that prescriber who has been designated to accept delivery of the drug samples as the prescriber’s designee; (b) receipt of the sample is documented in accordance with PDMA; and (c) the recordkeeping and other requirements of the PDMA and FDA regulations are met.
- Delivery to the Prescriber at Home. In recognition that prescribers may be practicing telemedicine from their homes, the FDA guidance clarifies that nothing in the PDMA specifies where a prescriber may receive delivery of drug samples. Accordingly, samples may be delivered to a prescriber’s home; provided all other requirements of the PDMA are met. This interpretation of the PDMA reflects FDA’s current thinking and is not anticipated to change following termination of the COVID-19 crisis.
- Delivery to Pharmacies. Under the PDMA, drug samples may not be distributed to retail pharmacies. The current guidance does not change this policy.
FDA’s rapid response to the COVID-19 crisis allows manufacturers to adapt their promotional sample distribution practices to the needs of patients and prescribers during the pandemic. However, in implementing these revised approaches, manufacturers must still ensure that they comply with the existing provisions of the PDMA and their own policies. The following are practical considerations that a manufacturer should bear in mind as it implements revised processes for sample dissemination in light of FDA’s guidance:
- Prescriber Licensing Verification: Cross-reference home addresses and office addresses with state licensing requirements for prescribers to confirm licensure in the state where the samples are to be delivered. Alternatively, some states have issued executive orders that provide regulatory flexibility for prescriber licensure during the pandemic, which might permit distribution to a physician in one state who practices in an adjoining state.
- Annual Audit: If samples are currently in the possession of field representatives and will be returned to a central location for redistribution, conduct the annual reconciliation audit at the time samples are returned.
- Handling Instructions: If samples are in the possession of field representatives and will be returned to a central location for redistribution, ensure any handling and storage instructions for the returned samples are disseminated, followed and documented.
- Patient Privacy: If the manufacturer plans to distribute samples directly to patients, ensure the receipt of Protected Health Information (PHI) is consistent with existing privacy policies. Create a mechanism to require the prescriber to obtain each patient’s authorization to disclose his or her PHI to the manufacturer. Have systems in place to ensure that the PHI is only used for the purpose of sample fulfilment.
- Physician Sample Inventory Monitoring: Because field sales representatives may be unable to perform a periodic physical audit of prescriber sample inventories, the manufacturer should evaluate its sample distribution practices in light of potential increased opportunities for fraud and diversion.