FDA grants first-ever approval for a state to import Canadian drugs

In what could be an important boost to efforts to hold down prescription drug costs, the U.S. Food and Drug Administration (FDA) announced it is authorizing the state of Florida to import some prescription drugs from Canada.

In a January 5 letter to Florida’s secretary for health care administration, the FDA said an importation proposal (SIP) the state submitted last year met the requirements of section 804 of the Federal Food, Drug and Cosmetic Act (FD&C) demonstrating that it will significantly reduce costs to consumers without posing additional risks to public health and safety. The authorization will stay in effect for two years.

While individual Americans have long been allowed to buy prescription drugs from Canada, where prices for most drugs are significantly lower, the FDA’s approval of Florida’s program marks the first time a state has received permission to do so. Florida has said it plans to import drugs for treating diabetes, AIDS, H.I.V. and hepatitis C, and estimates the program could save its taxpayers up to $150 million annually once it is fully implemented.

The FDA’s announcement generated immediate pushback from the Pharmaceutical Research and Manufacturers Association (PhRMA), the industry’s lobbying arm. In a statement on its website PhRMA President and CEO Stephen J. Ubl said, “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan. 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. Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients.”

Efforts to permit large-scale drug importations have been ongoing for decades on the state and federal level. In 2000, for example, Congress enacted the Medicine Equity and Drug Safety (MEDS) Act, which added Section 804 to the FD&C Act, permitting wholesalers to import prescription drugs directly from Canada and some other industrialized countries, subject to certain limitations and safeguards.

In 2021 President Biden issued an executive order that directed the FDA to work with states to import prescription drugs from Canada. In 2019 Florida established its Canadian Prescription Drug Importation Program in an effort to lower prescription drug prices. In 2022 the state sued the FDA, charging it with “continued inaction” to approve the program despite the executive order.

Even with today’s announcement, it may be some time before Florida can implement its importation program. As part of its approval, the FDA is requiring the state to:

• submit additional drug-specific information for the agency’s review and approval,
• ensure that the drugs Florida wants to import have been tested for, among other thing, authenticity and compliance with the FDA-approved drugs’ specifications and standards,
• relabel the drugs to be consistent with FDA-approved labeling, and
• submit a quarterly report to the FDA that includes information about the imported drugs, their cost savings and any potential safety and quality issues

In addition, the state will be responsible for ensuring supply chain integrity, monitoring and submitting adverse event reports and complying with drug recall procedures.