Miami, Florida – The importation of drugs approved by Health Canada into the United States may become a reality under a new program established by the FDA. Recently, the FDA approved a proposal for the Section 804 Importation Program (SIP) in Florida, making it the first state to receive approval for importing pharmaceuticals approved by a foreign regulator. This groundbreaking move could pave the way for other states, like Colorado, to seek FDA approval for similar programs.
While the availability of Canadian-approved drugs in the US is promising, it presents unique challenges for foreign manufacturers who may face potential mass tort litigation in the US for the first time. These manufacturers must carefully evaluate their US litigation strategy, particularly considering the role of Health Canada in approving and monitoring the medications, rather than the FDA.
The SIP program has implications not only for foreign manufacturers but also for US-based companies involved in the importation of Canadian-approved drugs. US distributors and pharmacies acting as importers under the SIP program may face increased litigation exposure.
Under the SIP program, an SIP sponsor, which can be a state or Indian Tribe, must submit a proposal to the FDA outlining its plan for importing specific prescription drugs that meet the necessary requirements. The drugs eligible for importation must have been approved by Health Canada and have an FDA-approved counterpart for re-labeling purposes.
The SIP also involves testing and pharmacovigilance requirements, with importers and manufacturers responsible for conducting tests to ensure compliance with FDA specifications. Additionally, the SIP sponsor must regularly update the FDA on the program’s progress and any safety issues.
For foreign manufacturers participating in the SIP program, navigating US mass tort litigation poses new challenges. They may need to consider legal strategies related to personal jurisdiction and forum non conveniens arguments. Additionally, the applicability of preemption arguments for drugs approved by Health Canada is a novel question that may impact state law claims.
US importers of Canadian drugs under the SIP program also face unique considerations. While they may not hold the regulatory license for the drugs they import, their involvement in testing and labeling responsibilities could expose them to claims of negligence. These importers may need to rely on evidence of compliance with SIP requirements to defend against such claims.
The approval of Florida’s SIP proposal is a significant step toward the potential importation of Canadian-approved drugs into the US. However, there are still challenges to overcome, including completing the full application process and addressing concerns about drug safety standards and potential shortages in Canada.
As the implementation of SIP moves forward, both foreign manufacturers and US importers must carefully navigate the legal implications of their involvement in the program. The availability of Canadian-approved drugs in the US market could have far-reaching effects on the pharmaceutical industry and mass tort litigation landscape.