On Jan. 5, Florida became the first state approved by the FDA to import cheaper medicines from Canada, but the plan is facing backlash from experts in Canada and the U.S.
Here's what to know:
1. The FDA authorized the state's plan through Section 804 of the Federal Food, Drug, and Cosmetic Act, but for each product Florida plans to import, the agency has to OK the proposal. Florida is also required to re-label drugs to meet FDA standards, test the drugs for authenticity and compliance, and submit quarterly reports on the cost savings and safety.
2. The importation plan differs from the nation temporarily ordering penicillin G benzathine, a syphilis drug, from a French drugmaker because this importation is because of a monthslong drug shortage rather than an effort to decrease drug prices.
In late August, Florida filed a lawsuit against the FDA, accusing the agency of "recklessly" delaying the decision on whether to approve the state's importation proposal.
3. Florida estimates the first year of the two-year program would save up to $180 million. The medications on the docket include HIV, AIDS, psychiatric and hepatitis C medications.
4. Pharmacy supply chain experts in Canada criticized the plan, arguing it could spur new or worsen ongoing drug shortages.
"It's almost laughable that the U.S. thinks that they're going to solve their problems about prices with Canadian drug supply, which is already stretched to the limit," Jacalyn Duffin, MD, PhD, a professor emerita of medical history and medicine at Queen's University in Kingston, Ontario, told CNBC.
On Jan. 16, Health Canada said it was disappointed with the FDA's decision, adding that the country "will take all necessary measures to protect the Canadian drug supply."
The American Society of Health-System Pharmacists and the American Pharmacists Association have also voiced concerns with Florida's new allowance. The ASHP said importing medications "is not a meaningful response to drug pricing" and can harm the pharmacist-patient relationship. The APhA argued it jeopardizes patient safety as the plan risks introducing counterfeit drugs to the U.S. market.
5. At least eight other states have submitted proposals to the FDA to import medicines: Colorado, Maine, North Dakota, New Mexico, New Hampshire, Texas, Vermont and Wisconsin. The agency rejected a proposal from New Hampshire in 2022, according to CNBC.