In early 2024, the FDA authorized Florida’s plans to import certain prescription drugs from Canada for the next two years, if doing so will lead to lower costs.
In a statement, Secretary of Florida’s Agency for Health Care Administration, Jason Weida, said, “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. As we move forward, we will continue to work every day to find ways to lower costs for Florida’s vulnerable populations.”
Canada, however, is not happy with the arrangement. Like many countries, Canada is currently experiencing a high number of drug shortages. A statement from Health Canada said, “Regulations have been implemented under the Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada. This includes all drugs that are eligible for bulk importation to the US, including those identified in Florida’s bulk importation plan, or any other US state’s future importation programs.”
Health Canada says it will be monitoring the Canadian drug supply to ensure that rules are followed and that drugs are not sent to Florida or elsewhere if the distribution will lead to shortages for Canada.
Other stakeholders also disapprove of the FDA plans, with PhRMA describing the plan as “reckless.” The association has raised concerns previously with importation plans because of safety. PhRMA’s website states: “Importation schemes have been proposed at various times as an approach to reducing drug costs. However, these schemes fail to acknowledge the resources required to ensure the safety and efficacy of any drugs being imported from or passing through other countries into the United States would outweigh any potential savings.”
PhRMA has also said it is “considering all options for preventing this policy from harming patients.”
The plans have also been criticized by numerous media outlets, but for different reasons. If Florida is looking for cheaper medicines, surely it should look to changing drug pricing internally within the US rather than turning to external countries. For The Globe and Mail, André Picard wrote, “Brand-name prescription drugs cost almost three times as much in the US as in Canada, for a host of reasons, including patent laws. The US does not negotiate prices with manufacturers nor does it regulate drug prices (as all other Western countries do). Mr. DeSantis, a right-wing Republican, supports these “free market” approaches. So, what is he doing instead? Proposing a backdoor approach, essentially importing Canada’s price controls and pretending that makes him a smart shopper.”
It’s possible that the approval of Florida’s plan will also lead to other states looking to Canada for more cheaper medicines. A number of states already have importation policies in place.
To ensure the safety of the medicines it imports (assuming Canada actually allows exports...), Florida will need to provide detailed information to the FDA on how it conducts visual inspections and laboratory testing to avoid potential counterfeit products; information on how it will ensure the supply chain is compliant with US regulations; a cost analysis demonstrating how the plan will lead to savings; and a return plan in the case that imported drugs are recalled.
What do you think? Let me know: stephanie.vine@texerepublishing.com
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