Responding to the times, the FDA issued a final guidance Monday allowing patients to get drug samples delivered to their homes for the duration of the COVID-19 public health emergency. Some rules must be followed. For instance, a licensed practitioner must request the samples in writing and designate specific patients who are to receive them. Receipt of the drug samples must be properly documented and manufacturers or the authorized distributor of record must comply with the recordkeeping and other requirements of the Prescription Drug Marketing Act (PMDA) and FDA Part 203 regulations. While direct-to-the-patient delivery is a temporary measure, the FDA said a provision allowing samples to be delivered to a physician’s home likely will become a permanent measure. Due to the rise of telemedicine, more doctors may be practicing from home offices. The FDA noted that neither the PMDA nor Part 203 prohibits delivery to a physician’s home, provided other requirements are met. The new leniency, whether temporary or permanent, doesn’t extend to everyone. The FDA reiterated that drug samples cannot be delivered to retail pharmacies, even during the pandemic.
Canada’s Minister of Health issued an interim order on the conduct of clinical trials for medical devices and drugs intended to treat COVID-19. The order, published in the June 6, 2020, Canada Gazette, applies to the import and sale of a device, other than Class I devices, or a drug, other than those described in Schedule C, that will be tested in a COVID-19 clinical trial. Products in a trial with a valid COVID-19 authorization will be exempt from Canada’s Medical Devices Regulations and certain drug regulations, according to the order. Besides explaining how to apply for a COVID-19 drug or device authorization, the interim order addresses a variety of clinical trial issues, including the need for approval from a research ethics board and labeling.