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Florida Gov. Ron DeSantis Launches Lawsuit Against FDA That Puts the Drug Regulator in a Major Dilemma

    Florida Gov. Ron DeSantis’ administration has filed a lawsuit alleging that the U.S. Food and Drug Administration has not complied with a public-records request that would shed light on why the FDA has not yet approved the state’s proposed program to import cheaper prescription drugs from Canada.

    Gov. DeSantis railed against the drug regulator at a press conference announcing the lawsuit.

    “630 days, you know, we still sit here waiting for an answer,” DeSantis said at a press conference. “And so it’s our view that we’ve waited long enough. And so today we’re taking action. The state of Florida has now filed a lawsuit against the FDA. They have unlawfully withheld and unreasonably delayed approval of Florida’s program. And we think this violates federal law. So we’re asking a federal judge to order the FDA to put an end to that delay and to approve Florida’s [plan].”

    The Florida lawsuit, filed in federal court on Monday, comes after the Agency for Health Care Administration filed a Freedom of Information Act request on July 6 that sought FDA records on Florida and other states’ drug-import proposals.

    “FOIA (the Freedom of Information Act) requires the FDA (Food and Drug Administration) to process records requests and promptly provide the requested records or the reasonably segregable portion of records not subject to a FOIA exemption,” the 11-page lawsuit said. “The FDA has neither provided AHCA (the Agency for Health Care Administration) any responsive documents in response to its request, nor has the FDA claimed that any responsive records are exempt from disclosure. Therefore, the FDA’s failure to produce requested records or claim applicable exemptions violates FOIA.”

    “In the nearly two years while Florida’s [Section 804 Importation Program] proposal has been pending, the FDA has asked for several clarifications and supplements but has provided no outward evidence of substantive progress towards approving the proposal,” the Florida lawsuit added, claiming that the “FDA has also refused to provide a timeline for the approval process.”

    “Plaintiffs accordingly bring this suit to compel the FDA to respond to the FOIA request and provide the requested documents,” the court filing continues.

    A Trump-era rule from 2020’s America First Health Plan opened the door to Canadian imports. A Fierce Pharma report explained how the mechanism for lowering drug prices would work.

    “Drug costs are lower in Canada because the country limits how much drugmakers can charge for medicines, Kaiser Health News explained in a September 2020 report. Nevertheless, the drug industry has long rallied against import efforts on the argument it could disrupt U.S. supply chains and ease the entry of unsafe or counterfeit medications onto the market,” the report notes.

    “Plus, market watchers have pointed out that Canada is a much smaller drug market than the U.S., so it wouldn’t be able to supply cheaper pharmaceuticals on a large scale,” the report continues.

    “Florida’s would-be maneuver to dodge high U.S. drug costs comes as the Biden administration makes its own play at the long-standing issue via the Inflation Reduction Act,” the report adds as background. “The bill, which President Joe Biden signed into law earlier this month, includes a number of drug pricing measures, which include giving Medicare the power to bargain for certain prescription drug costs.”

    Florida Gov. Ron DeSantis’s lawsuit presses the FDA to defend its policy of shielding Big Pharma from reliable and trustworthy foreign competition. It will be interesting to see if the FDA puts consumers first or Big Pharma first.

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