The FDA Safety and Landmark Advancements Act of 2022 (“FDASLA”), introduced in May, contains provisions regarding importing prescription drugs from Canada and the UK. After two years, the FDA could expand the FDASLA’s reach to allow the import of drugs from other Organization for Economic Co-operation and Development (OECD) countries. Although not originally included, the drug import provisions were added as an Amendment to FDASLA by the U.S. Senate Committee on Health, Education, Labor, and Pensions in June 2022. The full legislation was referred out of committee to the full Senate on July 13, 2022.
While this may seem like an important event in the ongoing debate over the benefits and risks of allowing certain prescription drugs to be imported from Canada or other foreign countries, the language within the Amendment is virtually identical to existing language within the FDA Importation of Prescription Drugs final rule effective November 30, 2020.
Multiple problems with the existing regulation were raised at the most recent NABP Task Force meeting held in September 2021. The primary issue dealt with basic supply chain issues. The representatives of Colorado’s and New Mexico’s Section 804 Importation Programs made it clear that the Programs lacked consideration of the details within supply chain logistics of moving medications from manufacturers to patients and, instead, focused on obtaining drugs from foreign sources. NABP Task Force members judged that the route from manufacturer to patient needed to be as short as possible to minimize risk. Members feared that countries like China and India provided most of the ingredients used to manufacture the drugs with “questionable oversight.” Such issues are significant and make it extremely difficult for the NABP or any state or federal agency with oversight authority to protect public health and ensure that prescription drugs are safe and effective for patients within the United States.
Concern was also raised regarding which agencies would be given enforcement responsibilities. Cases that arise could potentially involve multiple agencies in different countries worldwide. Even if issues only involved drugs manufactured in and imported from Canada, it is not clear who would be responsible for ensuring that no counterfeit or unsafe drugs were provided to patients within the United States. Multiple Task Force members questioned whether there would be any cost savings for U.S. patients who purchased prescription drugs from foreign sources.