Policy & Medicine - Legal, Regulatory, and Compliance Issues
In July 2022, Florida Governor Ron DeSantis hinted at potential litigation over the state’s Canadian drug import plan while at a press conference ahead of signing an executive order on pharmacy benefit managers (PBMs).
In May 2022, the United States Food and Drug Administration (FDA) released Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide. In the guidance, the FDA pointed to strict limitations regarding what can be imported from Canada and provided direction on how state plans can be approved, including the requirement that they result in a significant cost savings to consumers. It also included a long list of drugs that will be excluded from any state’s importation plan – to include all biologics, controlled substances, infused drugs, intravenous drugs, intrathecal drugs, intraocular drugs, and drugs that are subject to a risk evaluation and mitigation strategy (REMS).
However, the FDA has not yet done anything to approve Florida’s November 2020 request to approve the state’s plan for Canadian imports. Florida plans to begin its importation by importing a few drug classes which will include maintenance medications to help individuals and consumers that have chronic health conditions such as asthma, COPD, diabetes, and HIV/AIDS. DeSantis noted that the plan would save “hundreds of millions of dollars” by allowing Canadian imports of “the same drugs,” and that without an approval of the plan, “we may even end up in litigation over this.”
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In fact, the FDA has not signed off on any of the five state plans in the works – Florida, Colorado, Maine, New Mexico, or Vermont – and PhRMA’s lawsuit to block the rule that allows such imports is also in a holding pattern. This is despite April 2022 communications with states regarding their import plans, holding a forum to discuss best practices and listening to some of the challenges. While the FDA found the conversation to be constructive and helpful, it did not make any commitments, instead saying it will notify the states in the future in writing when a decision has been made either way – to authorize or not authorize – regarding its Section 804 Importation Program proposal.
DeSantis noted during his press conference that the state has a “massive warehouse” ready to go to relabel the drug imports from Canada, as required by the FDA. He also pushed back on statements from the FDA and PhRMA that have raised concerns about safety issues with imports.
DeSantis’ statements follow his July 6, 2022, Freedom of Information Act (FOIA) request for details on why the FDA has not yet reviewed Florida’s importation plan. “Maybe they just don’t want to give Florida a win, and that wouldn’t be surprising knowing what they’re doing,” DeSantis said. “It may be that pharma has told them they don’t want this. So we’ve got to stop making policy just based on what pharma wants.”
Thomas Sullivan is Editor of Policy and Medicine, President of Rockpointe Corporation, founded in 1995 to provide continuing medical education to healthcare professionals around the world. Prior to founding Rockpointe, Thomas worked as a political consultant.
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