The US Food and Drug Administration (FDA) will allow Florida to import medications from Canada in bulk after decades of attempts by other states to buy drugs from the country at lower prices, the agency announced today.
Florida would become the first state to be granted the FDA approval for importing the drugs and the state estimates it could save up to $150 million in its first year of the program.
In its filed complaint, Florida stated, “Certain critical prescription drugs can cost Florida almost $400 per pill, putting a significant strain on its healthcare budget.”
According to a New York Times report, the state would be able to buy the drugs from Canadian wholesalers for the state’s Medicaid program, prisons, and government clinics.
While individual patients in the US have been able to buy medicines from Canada, states have not been able to buy in bulk from Canada for such programs.
The move would be a blow to the pharmaceutical industry, which has long fought such attempts to import the drugs.
According to the Times report, the industry’s major lobbying organization, the Pharmaceutical Research and Manufacturers of America, (PhRMA) “which has sued over previous importation efforts, is expected to file suit to prevent the Florida plan from going into effect."
Today, PhRMA President and CEO Stephen J. Ubl called the FDA decision "reckless," noting in a statement: “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.”
Additional significant obstacles remain. One of them involves available supply in Canada. The Times reports that, according to Maryse Durette, a spokeswoman for Health Canada, “Canada’s drug supply is too small to meet the demands of both American and Canadian consumers. Bulk importation will not provide an effective solution to the problem of high drug prices in the US.”
Eight other states – Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin – already have legislation in place for a state drug importation program and many plan to request FDA approval or already requesting it, the Times reports.
The FDA made the approval through the drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
“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.”
While the US Congress allowed drug importation two decades ago, federal officials have delayed implementing it, citing safety concerns, which is one of the main points pharma makes in its arguments against bulk importation, the Times notes.
The FDA is authorizing the importation for two years from the date the FDA is notified of the first shipment of drugs to be imported. Before drugs can be imported, the FDA says, Florida’s Agency for Health Care Administration must:
Ensure that the drugs Florida wants to import “have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards”
Relabel the drugs to be consistent with FDA-approved labeling
In addition, Florida must submit a quarterly report to the FDA with information about the imported drugs, cost savings and any potential safety and quality concerns.
Editor’s Note: We will provide updates to this unfolding story as they occur. Last updated January 5, 2024, 4 pm.
