Florida wants to import prescription drugs from Canada. The FDA still says no
Nearly three years after Florida lawmakers approved a plan to import cheaper prescription drugs from Canada, Governor Ron DeSantis expressed frustration on Tuesday that the plan remains stalled in Washington, D.C.
DeSantis and then-State House Speaker Jose Oliva, R-Miami Lakes, made the issue a priority in 2019 as lawmakers eventually approved a plan to make imported drugs available in programs related to government.
Former President Donald Trump’s administration approved a rule in 2020 to help clear the way for imports, but groups such as Pharmaceutical Research & Manufacturers of America have launched a legal challenge that remains unresolved.
During a Tuesday appearance in Jefferson County, DeSantis said the state had “worked really hard” on the matter.
“But it’s been a long-time source of frustration, that it’s something that just hasn’t been approved,” DeSantis said. “Because ultimately, you know, it would hurt some of Big Pharma’s profits. But you know, to be honest with you, I’m much more worried about your ability to pay for your drugs than Big Pharma.
DeSantis said he has worked with Trump on the issue and President Joe Biden has indicated he wants to move forward with importing drugs. DeSantis criticized the US Food and Drug Administration on Tuesday.
“The FDA didn’t do anything,” he said. “So I can only interpret that to mean that they’re probably hoping for it to dry out on the vine.”
But the lawsuit, filed by Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines and the Council for Affordable Health Coverage, progressed slowly in US District Court in Washington.
Federal attorneys filed a motion in August to dismiss the case, but plaintiffs opposed the dismissal – with Florida playing a leading role in the legal wrangling.
In the motion to dismiss, federal prosecutors argued that the plaintiffs were not harmed by the 2020 rule and another type of endorsement known as certification. The motion said Florida was proposing a program – identified by an acronym as a “SIP” program – to import drugs but that it had not been approved.
“Authorization depends on a program’s initial (and sustained) ability to meet a host of stringent patient safety and drug supply chain security requirements, as well as demonstrate significant cost savings to U.S. consumers,” the motion to dismiss said.
“The FDA has the discretion to refuse any proposal that apparently does not meet these requirements. Even if a proposal appears to be complete, the agency can still deny authorization — for example, if the proposal does not sufficiently protect public health or demonstrate significant enough savings for U.S. consumers. Unless and until the FDA authorizes a SIP, neither the law nor the implementing regulations impose any requirements.
But in a Sept. 30 court document opposing the dismissal, plaintiffs’ attorneys pointed to Florida’s proposal, saying the case should be allowed to proceed. The document states that Florida is “seeking to import approximately 100 drugs, the majority of which are manufactured in applications held by identifiable members of the PhRMA (Pharmaceutical Research and Manufacturers of America).”
“Florida has earmarked millions of dollars to fund the operation of the SIP,” the document states. “They engaged a third-party logistics company to handle the day-to-day operation of their proposed SIP, and they retained the services of a Canadian wholesaler to be the overseas seller. Florida Governor DeSantis said the state is “ready to roll” as soon as the FDA approves its SIP, promising the state will begin importing drugs “within 90 days of approval.”
In a friend of the court filing last year, attorneys for the Florida Agency for Health Care Administration wrote that the state’s proposal “is initially intended to provide safe, low-cost drugs.” cost to Floridians who need maintenance medications for chronic health conditions.” such as asthma, COPD, diabetes and HIV/AIDS. In particular, these drugs will help Florida meet the needs of vulnerable populations who depend on the state for access to their medications.
The agency’s brief backed the contested federal rule, saying reducing drug costs is a top concern for Americans.
“With the final rule…states and tribes have the ability to take legal action to reduce drug costs,” the brief reads. “At the same time, the final rule takes great care to ensure that adequate safeguards are in place to ensure that these imported drugs are safe.”
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