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.[1] 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.[2] 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.[3]
Multiple problems with the existing regulation were raised at the most recent NABP Task Force meeting held in September 2021.[4] 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.[5] 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.
The language within the pending (July 2022) version of FDASLA and the 2020 Importation of Prescription Drugs final rule both require state Section 804 Importation Programs to have procedures to ensure each prescription drug imported under their programs is safe and effective for its intended use.[6] For example, the Importation Program proposed by Colorado requires authenticity testing and relabeling of the imported medication, including new National Drug Codes. Colorado will also incur costs associated with the administration of the program.[7] The Department of Health Care Policy & Financing in Colorado, charged with administering the program, stated on its website that it was pursuing a vendor to perform supervision functions. That vendor would perform administration functions to the Foreign Seller (Canadian Wholesaler) and Colorado Importer (U.S. Wholesaler or Pharmacist), responsible for testing, relabeling, and drug distribution to participating pharmacies. With no current vendor to perform these administrative functions, it is difficult to determine actual cost savings for U.S. patients.
Issues regarding the reimbursement of imported prescription drugs were also raised by NAPB members.[8] Would such drugs be approved by the FDA, and would the costs for those drugs be eligible for submission to federally funded programs for reimbursement? Also, would U.S. patients living outside a state with an approved Section 804 Importation Program be allowed to purchase imported prescription drugs from another state?
A concern seldom expressed within the import debate is whether Canada would have enough supply of the needed drugs as more and more states begin importing. Would such programs result in drug shortages for Canadian consumers? Under the Drug Importation Program Frequently Asked Questions section of the Colorado Department of Health Care Policy and Financing website, one of the FAQs was whether a Colorado representative had spoken to Canadian representatives about the program.[9] The response was that the Department has had conversations with the Denver Canadian consulate and would welcome and anticipate more communication down the road.
Pharmaceutical professionals, health officials, and their legal advisors should monitor the progress of FDASLA to determine whether and how these issues are addressed as the legislation evolves.
FDASLA Act of 2022, S. 4348, 117th Congress (2022), https://www.congress.gov/bill/117th-congress/senate-bill/4348. ↑
At the time of writing, a transcript of the hearing was not available. However, video of the hearing is available on the committee’s website, at https://www.help.senate.gov/hearings/s-4348-s-958-s-4353-hr-1193-and-s-4053. ↑
See, 21 C.F.R. § 251.1, et seq. (2022). ↑
Nat’l Ass’n of Bds. of Pharmacy, Report of the Task Force on State Oversight of Drug Importation (2021), https://nabp.pharmacy/wp-content/uploads/2021/12/Report-of-the-Task-Force-on-State-Oversight-of-Drug-Importation.pdf. ↑
Id., at 2. ↑
Senate Bill 4348, at § 906, which amends the Food, Drug, and Cosmetic Act (21 U.S.C. § 384) to include the final rule’s definition of “section 804 importation program sponsor” to include “a State or Indian Tribe that regulates wholesale drug distribution and the practice of pharmacy”; cf. 21 C.F.R. § 251.2 (2022). ↑
Colo. Dep’t of Health Care Policy & Fin., Colorado’s Canadian Drug Importation Program: Frequently Asked Questions (2021), at 6, https://hcpf.colorado.gov/sites/hcpf/files/ Drug%20Importation%20Program%20FAQs%20Jan%202021.pdf. ↑
Supra note 4, at 3. ↑
Supra note 7, at 2. ↑
