FDA Issues First Approval for Large-Scale Drug Imports From Canada

WASHINGTON — The Food and Drug Administration on Friday authorized Florida to purchase millions of dollars’ worth of medications from Canada, a move long opposed by the pharmaceutical industry.

The goal of the approval is to give states access to medications at far lower prices than they can get them from U.S. wholesalers.

It is also a major policy shift, set in motion by former President Donald Trump, but dramatically accelerated by President Joe Biden.

In its letter of approval, issued to the Florida Agency for Health Care Administration, the FDA said, “Florida has demonstrated that it meets the statutory obligation to ensure that importation [of medications from Canada] will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.”

The authorization is for two years, starting on the day the FDA is notified of the first imports.

Individuals in the United States have been allowed to buy directly from Canadian pharmacies for years, and while Congress passed a law allowing states to begin such drug importations more than 20 years ago, federal health officials delayed implementing it, citing safety concerns.

States have long desired the ability to purchase medicines in bulk to secure lower prices for those enrolled in their Medicaid programs, patrons of government-run clinics and for serving prison inmates.

In a filing with the FDA in mid-November, Florida state officials estimated the state would save an estimated $150 million in its first year of the program, importing medicines that treat HIV, AIDS, diabetes, hepatitis C and some mental health conditions. 

But while state officials were celebrating the decision, the Pharmaceutical Research and Manufacturers of America, or PhRMA, the industry’s lobbying organization, roundly panned it.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” said PhRMA President and CEO Stephen J. Ubl in a written 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,” he continued. 

“Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients,” Ubl said.

In a press release, the FDA said its authorization of drug imports under the Federal Food, Drug, and Cosmetic Act is in accordance with Biden’s executive order on promoting competition in the American economy.

As part of the order, it said, the president “directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety.” 

But the agency also stressed that authorization is just the first step of a process. Before drugs can be imported, Florida’s Agency for Health Care Administration must:

• Submit additional drug-specific information for the FDA’s review and approval.
• Ensure that the drugs Florida seeks 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 the FDA-approved labeling.
• Submit a quarterly report to the FDA that includes information about the imported drugs, cost savings. and any potential safety and quality issues. 

“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M. Califf, M.D., in a written 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,” Califf added.

Dan can be reached at [email protected] and @DanMcCue