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The FDA has permitted Florida to import a vast amount of medications from Canada at significantly lower prices than those in the U.S., overriding longstanding opposition from the pharmaceutical sector. Florida anticipates that the program could save it up to $150 million in the first year by importing medicines for conditions such as HIV, AIDS, diabetes, and hepatitis C. However, this step faces resistance from the pharmaceutical industry, and concerns have been raised about the Canadian drug supply’s capacity to meet the needs of both American and Canadian consumers.
Florida Allowed by FDA to Import Medications from Canada
The Food and Drug Administration has approved Florida’s request to import medications from Canada at reduced prices, overriding decades-long objections from the pharmaceutical industry. The approval issued to Florida is a significant policy shift in the United States, potentially aiding efforts to regulate drug prices. States can now make bulk purchases for Medicaid programs, government clinics, and prisons from Canadian wholesalers.
Florida anticipates saving up to $150 million in its first year of the program, importing medicines for H.I.V., AIDS, diabetes, hepatitis C, and psychiatric conditions. Several states have submitted applications to the FDA for similar programs. However, obstacles remain as some drug manufacturers have agreements with Canadian wholesalers prohibiting exports, and the Canadian government has already taken steps to block the export of prescription drugs that are in short supply.
Although Congress passed a law allowing drug importation two decades ago, implementation was delayed for years due to safety concerns. In 2020, President Trump moved the law forward, announcing that states could submit importation proposals to the FDA for review. President Biden added momentum the following year, instructing federal officials to continue working with states on importation plans.
Florida’s Application and Additional State Applications
Florida applied and later sued the FDA, accusing the agency of a “reckless delay” in approving the request. The lawsuit resulted in Friday’s announcement, in which a federal judge set a Jan. 5 deadline for the FDA to act on the state’s application. FDA Commissioner, Dr. Robert Califf, stated that the agency is vetting additional state applications to ensure they align with the program’s goals.
Eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin — have laws allowing for a state drug importation program, and many are seeking or planning to seek FDA approval. Colorado’s application is currently pending with the FDA.
Challenges and Public Support for Drug Importation
Despite broad public support shown in a 2019 KFF poll, states may face challenges from drugmakers in Canada. Some drugmakers have contracts with drug-shipping companies prohibiting deliveries to the U.S., according to a report by Colorado officials.
As the 2024 presidential election approaches, candidates are highlighting efforts to reduce drug prices. However, experts in pharmaceutical policy argue that importation from Canada would not address the root cause of high drug prices, namely the ability of pharmaceutical makers to fend off generic competition by gaming the patent system, and the government’s failure to negotiate directly with drugmakers over cost.
Next Steps for Florida After FDA Approval
With its approval in hand, Florida has more work to do. The state must send the FDA details on the drugs it plans to import and demonstrate that they are potent and authentic. Florida’s approval to import lasts for two years from the date of the first drug shipment. The FDA will monitor Florida to ensure it upholds safety rules and delivers significant cost savings to consumers.
In Canada, health officials have expressed concerns over the push to import from their country. The Canadian government has published its own rule to prevent manufacturers and wholesalers from exporting drugs that are in short supply.
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