FDA Allows Florida to Import Cheaper Drugs From Canada

Fact checked by Nick Blackmer

Key Takeaways

• Florida recently received approval from the FDA to import drugs from Canada.

• These medications are cheaper than they are in the U.S.

• The program is expected to save millions of dollars in drug costs.

The Food and Drug Administration (FDA) has approved a proposed plan from the state of Florida to import select drugs from Canada. This is the first step in Florida being able to import these medications.

This authorization will last two years from the date the FDA is notified of the first shipment of drugs that will be imported, the FDA said in a press release. The importation will be allowed under section 804 of the Federal Food, Drug, and Cosmetic Act.

This move raises a lot of questions about why Florida would want to import drugs from Canada, which drugs will be available, and who will benefit from this. Here’s what you need to know.

Canadian Drugs Are Cheaper

It all comes down to cost.

“The appeal is to lower cost of prescription drugs to the consumer,” Anthony J. Pattin, PharmD, clinical associate professor in the School of Pharmacy and Pharmaceutical Sciences at the University at Buffalo, told Verywell. “Prescription drugs from Canada are cheaper for various reasons.”

The reason why medication is less expensive in Canada is complicated, Tobias Gerhard, PhD, director of the Rutgers Institute for Health, Health Care Policy and Aging Research, told Verywell.

“Canada’s government, like most of the world, negotiates prices with pharmaceutical companies and sets maximum allowable prices,” he said. “The U.S. government does not negotiate drug pricing with pharmaceutical companies.”

Canada has what’s known as a “single payer” healthcare system funded by its federal government, Pattin explained, and the negotiations with drug companies lower prices of medications for the country’s healthcare system.

“The United States is not a single-payer system, and in the past, the government has not negotiated lower drug prices,” Pattin said. “However, a new federal law, the Inflation Reduction Act, was signed in August 2022. It will allow the federal government to negotiate lower drug prices for Medicare patients for a select number of drugs. It is expected this will save the industry billions of dollars.”

Who Is Eligible for Cheaper Drugs?

This is currently just a program that will be eligible to select Florida residents. Those include people in the Medicaid program, inmates, and patients at county health departments that are managed by the Florida State Department of Health.

However, this is a program that other states could take advantage of as well.

“All states can create a drug importation policy,” Pattin said. “However, there are specific regulations that must be followed to implement a program. States must first request approval from the FDA.”

Which Drugs Are Impacted?

The FDA noted that Florida officials must submit drug-specific information for review and approval before they’re approved. They also will need to be re-labeled to be consistent with FDA-approved labeling.

Florida said it plans to import medications for HIV/AIDS, diabetes, hepatitis C, psychiatric disorders, and more.

Related: A Verywell Report: Insulin Price Cuts Barely Move the Needle for Americans

Why Isn’t Every State Doing This?

Some other states are trying to follow a similar approach right night.

“Other states have drug importation laws, including Colorado, Maine, and New Hampshire,” Pattin said. “Colorado passed a bill in 2019 for a drug importation. However, it appears that the program has not been successful, according to Colorado’s Drug Importation Program 2023 annual report.”

Among other things, the report noted that there were several challenges, including trouble getting certain medications due to manufacturer contracts that prohibited drugs being exported, resistance from drug companies, and lack of regulatory clarity from the federal government, Pattin said.

It can also be tough to get enough drugs from Canada to supply multiple states.

“Due to the limited drug supply, it won’t be easy to make any significant impact on drug prices for American citizens,” Pattin said. “Canada has a total population of 40 million, while the state of Florida has 22 million residents alone. It isn’t feasible that multiple states can use this strategy because of limited drug supplies.”

Florida Faces Opposition

Pharmaceutical companies largely oppose this.

“There is significant resistance by drug manufacturers,” Pattin said. “The Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents pharmaceutical companies, is a big opponent of this regulation. They are looking at all of their options to oppose this, including filing a lawsuit to impede the implementation of Florida’s plan.”

There aren’t necessarily safety concerns around this plan, though.

“Part of the deal is that states that import drugs have to re-label the drugs to meet United States regulatory requirements,” Pattin said. “Additionally, they have to ensure drugs are safe and not counterfeit, so that may involve independent testing of the drug supply.”

When Will Florida Be Able to Import Drugs?

Not just yet. State officials need to meet more regulatory requirements laid out by the FDA.

“It will still take some time before the program is actually importing drugs,” Pattin said. “The state of Florida will still have to submit what drugs they plan to import and a plan to ensure the drugs are safe and effective. Additionally, Florida may encounter similar problems to those mentioned in Colorado’s program.”

However, experts said this move should help some Florida residents.

“The fact remains that drugs in the U.S. are more expensive than in most of the world,” Gerhard said.

What This Means For You

If you’re a Florida resident, you may be able to save money on select prescription medications in the future. If you live in another state, this plan won’t impact you. However, if you’re having trouble accessing affordable medication, talk to your doctor. They may be able to recommend a generic or similar option to help.

Read the original article on Verywell Health.