Florida will soon be able to import prescription drugs from Canada. What to know

Florida is the first state to be given the OK by federal regulators to import certain prescription drugs from Canada, a move that is expected to help save taxpayers millions.

The U.S. Food and Drug Administration authorized the state’s request to import medication from Canada on Friday, the deadline given by a judge in a lawsuit over the issue.

While some people already buy medicines from pharmacies in Canada or Mexico, it’s technically illegal to import them, according to the Associated Press.

With this approval, Florida will be able to import medications for its Medicaid recipients, as well as for facilities run by the Florida Department of Children and Families, people who are under the care of the Florida Agency for Persons with Disabilities, patients at county health departments and inmates in the custody of the Florida Department of Corrections.

“After three long years of waiting for FDA approval, we are excited to finally have the opportunity to see this vision come to fruition and provide Floridians access to safe and affordable prescription drugs,” said Jason Weida, secretary for Florida’s Agency for Health Care Administration, in a statement. “As we move forward, we will continue to work every day to find ways to lower costs for Florida’s vulnerable populations.”

The state on Friday said it estimates the program will save Florida taxpayers $183 million per year once the program is fully implemented, with plans to import medications to treat various conditions, including HIV, AIDS, mental illness, prostate cancer and urea cycle disorder. The state expects to save up to $180 million in the first year.

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However, before the state can begin importing drugs from Canada, Florida’s Agency for Health Care Administration will have to tell the FDA what drugs it wants to import, verify that the drugs are tested, authentic, comply with the FDA’s standards, and relabel the drugs to be consistent with FDA-approved labeling. The FDA will have to review and approve the drugs.

The state agency will also be required to submit a quarterly report to the FDA that includes information about the imported drugs, cost savings and any possible safety and quality issues. Under the authorization, Florida will be allowed to import select drugs from Canada for two years from the date the FDA is notified of the first drug shipment to be imported.

Other states have also submitted requests to the FDA to import medications from Canada. FDA Commissioner Robert Califf said the agency is committed to working with states and Indian tribes who create proposals that demonstrate programs that would “result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

Prescription drugs cost more in the U.S. than in other countries, in part because the U.S. doesn’t impose a limit as to how much pharmaceutical companies can charge, while other countries, like Canada, do. However, Medicare, the federal health insurance program for seniors, can now negotiate with drug companies on certain high-cost medications because of the Inflation Reduction Act, with negotiated prices set to go into effect in 2026.

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In 2021, the U.S. Government Accountability Office did an estimate comparison of the prices for 20 brand-name drugs in the U.S. to the same drugs in Australia, Canada and France. Its analysis found that retail prices in the U.S. for these drugs were 2 to 4 times higher than in other countries. Florida says some medications cost almost $400 per pill.

While Congress passed a law allowing drug importation two decades ago, federal officials kept delaying it over safety concerns, one of the main arguments drug companies have used against it, the New York Times reported.

Then in 2020, President Donald Trump green-lit states to submit proposals to the FDA to import medications from Canada. President Joe Biden continued the push in 2021 with an executive order directing the FDA to work with states and Indian tribes to ensure that their importation programs could help reduce the cost of medication for people in the U.S., while still ensuring that the drugs were safe.

In Florida, Gov. Ron DeSantis in 2019 signed into law a bill that would let the state import prescription drugs from different countries, including Canada. The state first needed to get its drug importation program approved by the FDA. The state applied in 2020, and nearly two years later, sued the federal agency over its delay in reviewing its proposal. A federal judge ordered the FDA to decide on Florida’s proposal by Jan. 5.

Will importing medicine from Canada make U.S. prices cheaper?

There’s support in the U.S. to import medications from Canada. A 2019 survey by KFF, a nonprofit health research group, found that nearly 80% of respondents support buying prescription drugs imported from licensed Canadian pharmacies. However, some experts have expressed skepticism about how effective the importation of Canadian medications will be in reducing the cost of pricey, brand-name drugs.

“Pharma is smart. They know exactly how much Canada needs to buy. They’re not going to oversell to Canada knowing it can be imported into the U.S., especially for a big state like Florida,” said Emma Dean, assistant professor of health management policy at the University of Miami Patti and Allan Herbert Business School.

“It’s politically popular. People like to think that they can pay Canadian prices, the practical reality is they probably won’t change most people’s prices they pay,” Dean added.

The pharmaceutical industry is also against the push to import medications from other countries. It’s warning that allowing medications from foreign countries could pose a health risk, despite the fact that the imported drugs would have to comply with FDA standards.

“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,” Pharmaceutical Research and Manufacturers of America, a trade group for pharmaceutical companies, said in a Friday statement.

Canada likely won’t make it easy, either.

In 2020, Canada prohibited companies from exporting certain medications meant for the Canadian market to other countries like the U.S. if it would cause or worsen a drug shortage in Canada. The Canadian government has also previously cast doubt on whether the U.S. push to import Canadian medication would reduce drug prices, noting that the Canadian market is smaller.

In a statement released Friday evening, the Public Health Agency of Canada said that the 2020 measure covered “all drugs that are eligible for bulk importation to the U.S., including those identified in Florida’s bulk importation plan, or any other US state’s future importation programs.”

Anne Génier, spokesperson for the agency, said the Canadian government’s priority is protecting the domestic supply of prescription drugs.

“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.” she wrote.