TALLAHASSEE, Fla. – The U.S. Food and Drug Administration (FDA) has recently approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the United States. This marks the first time that a program of its kind has been implemented, enabling a state to import drugs approved by a foreign regulator. The program, known as the Section 804 Importation Program (SIP), allows U.S. states or tribes to apply for approval to import drugs that were initially approved by Health Canada instead of the FDA.
Florida is the first state to receive FDA approval for the SIP program, with other states also expressing interest in seeking approval. While the availability of Canadian-approved drugs in the U.S. is a significant development, it raises important legal considerations for foreign manufacturers and U.S. distributors and pharmacies.
Foreign manufacturers must carefully evaluate their U.S. litigation strategy, including potential legal defenses and the role of Health Canada in approving and monitoring the medications. In particular, they should anticipate challenges to the jurisdiction of U.S. courts and consider the doctrine of forum non conveniens, which allows a court to dismiss a case if it is determined that another forum would be more appropriate.
One potential defense for manufacturers is preemption, which asserts that compliance with federal requirements makes it impossible for them to comply with state laws. It remains uncertain whether preemption arguments can be successfully raised for drugs approved by Health Canada under the SIP program, as there may be conflicting obligations under federal and state law.
Another key consideration is the labeling of imported drugs. Manufacturers can invoke the “learned intermediary doctrine,” which places the duty to warn about drug risks on prescribing physicians rather than manufacturers. However, the doctrine’s applicability may vary across jurisdictions, and plaintiffs may challenge its effectiveness if the alleged injury was not disclosed on the drug’s label.
For U.S. distributors and pharmacies acting as importers under the SIP program, their role in the supply chain may expose them to potential liability. While distributors and retailers are often successful in asserting preemption defenses in typical drug supply chains, the unique circumstances of the SIP program, including the involvement of foreign regulators and importers’ responsibilities in testing and relabeling, may impact the viability of these defenses.
Overall, the approval of Florida’s SIP proposal has paved the way for the importation of Canadian-approved drugs into the U.S. However, there are still significant challenges and opposition to overcome before the program can be fully implemented. As the program progresses, foreign manufacturers and U.S. importers must carefully consider the legal implications and develop strategies to navigate potential litigation and liability issues.