FDA clears mass importing of Canadian drugs
The U.S. Food and Drug Administration (FDA) has authorized Florida’s drug importation program, marking the state’s first step toward bringing in certain prescription drugs from our northern neighbors—at significantly reduced costs.
Florida’s program was the first cleared under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The pathway allows states or Indian tribes to import certain drugs via submission of section 804 importation program (SIP) proposals, so long as the reductions in costs don’t have harmful side effects.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert M. Califf, MD, said in a statement. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
Under Florida’s two-year SIP, the state’s Agency for Health Care Administration must:
- Submit additional drug-specific information for the FDA’s review and approval
- Ensure ensuring supply chain integrity
- Relabel the drugs to be consistent with the FDA-approved labeling
- Submit quarterly reports to the FDA that includes information about the imported drugs, cost savings and any potential safety and quality issues.
State sponsors will be responsible for implementing all aspects of their program, including importation and distribution, and will be required to submit adverse event reports and comply with drug recall procedures.
The shift in policy was the result of President Biden’s Executive Order on Promoting Competition in the American Economy, which directed the FDA to work with states to bring down costs.
Stephen J. Ubl, President and CEO at the Pharmaceutical Research and Manufacturers of America (PhRMA), described the decision as “reckless” in a statement.
"Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Ubl said. “PhRMA is considering all options for preventing this policy from harming patients.”
Colorado, Maine, New Hampshire, New Mexico, North Dakota, Vermont and Wisconsin have laws allowing for a state drug importation program should they also receive FDA approval, according to the National Conference of State Legislatures.
Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.