Florida says FDA stalling on drug importation program in suit

 It’s Florida versus the U.S. Food and Drug Administration as the state’s quest to import cheaper prescription meds from up north has veered into court this week.

Florida is suing the U.S. drug regulator for allegedly dragging its feet on a Freedom of Information Act (FOIA) request linked to a drug importation program. Florida Gov. Ron DeSantis inked legislation on the issue back in June 2019.

The so-called Canadian Prescription Drug Importation Program aims to do what it says on the tin: bring cheaper medicines from Canada to the Sunshine State.

Florida is one of a handful of states angling to draw down cheaper medicines from Canada. Other states seeking permission to buy drugs from the Great White North include Colorado, Maine, New Hampshire, New Mexico and Vermont.

Back in 2020, then-President Donald Trump blessed a rule paving the way for such imports, though the measure has been met with opposition from industry heavyweights like the Pharmaceutical Research and Manufacturers of America. 

The trade group at the time voiced “grave concerns” about the drug import plan’s potential to expose people in the U.S. to “the dangers of counterfeit or adulterated drugs,” though its own lawsuit to block the Trump-era decision has since stalled, Endpoints News points out.

For its part, the FDA says it's "working to implement a statutory pathway for the importation of certain prescription drugs from Canada." 

Florida predicts the program could save local taxpayers up to $150 million a year once fully rolled out, according to a lawsuit filed Monday in Tampa Federal Court. The plan would start by importing drugs to treat HIV and AIDS as well as diabetes, hepatitis C and mental illness, the court documents state.

Florida says it’s “ready, willing, and able to begin operating the program immediately,” pointing out that it’s “already built” a refrigerated distribution center and locked in an approved importer and distributor that's currently on retainer for $1.2 million a month.

But Florida’s ability to kick off the import scheme is “stuck in the starting blocks” because the FDA must first approve the program, for which the state claims it submitted the required proposals back in November 2020.

“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 states, adding that the “FDA has also refused to provide a timeline for the approval process.”

Because the regulator has allegedly been twiddling its thumbs, Florida’s Agency for Health Care Administration secretary, Simone Marstiller, submitted a FOIA request July 6 demanding multiple records related to drug importation proposals from Florida and other states.

Problem is, the FDA has not responded according to the deadline specified in the request, the state contends in its lawsuit against the regulator.

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

The 2020 Trump-era rule opening the door to Canadian imports came as part of the former president’s America First Health Plan.

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.

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. 

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 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. 

The bill is also set to cap per-patient out-of-pocket costs at $2,000 per year in Medicare and is expected to shift more responsibility for expenses beyond that limit onto payers. The biopharma industry also ardently resisted the Biden administration measures.

https://www.fiercepharma.com/pharma/florida-tees-legal-showdown-fda-over-stalled-information-act-request-canada-drug-import-plan