Sunday, May 5, 2024

Florida sues FDA over ‘delay’ of low-cost drug importations


TALLAHASSEE – Florida sued federal well being officers on Wednesday, accusing them of stalling the state’s plan to import lower-cost prescribed drugs from Canada.

Republican Gov. Ron DeSantis introduced the lawsuit towards the U.S. Department of Health and Human Services and Food and Drug Administration at a news convention.

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“Florida has been ready to deliver cheaper prescription drugs to those that need them for nearly two years,” DeSantis mentioned. “The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation.”

The U.S. pharmaceutical trade for years has confronted complaints over excessive costs and has been capable of efficiently foyer towards proposals to import medication at decrease prices. Critics have argued importing medication might result in dangers of counterfeit or ineffective drugs that might be troublesome for American governments to control.

Democratic President Joe Biden has backed such importation packages as a option to decrease costs, signing an government order in 2021 that directed the FDA to work with states on creating proposals to ship medication to the U.S. beneath federal regulation.

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A spokesman from the Department of Health and Human Services declined to remark, citing pending litigation.

Under President Joe Biden’s landmark Inflation Reduction Act signed into regulation earlier this month, the federal authorities is ready to realize the facility to barter decrease drug costs for seniors in Medicare. The financial savings will solely apply to a handful of medication beginning in 2026, however it represents a breakthrough in efforts to carry down drug costs. That and different cost-saving measures within the regulation might scale back demand for cheaper imports from Canada.

Florida’s Republican-controlled Legislature accepted the state’s importation program in 2019, however it requires approval from federal well being officers earlier than it could take impact. The state estimates taxpayers might save as much as $150 million yearly beneath this system, with supporters saying the medication would nonetheless want to satisfy FDA requirements and that 80% of drug components used within the U.S. are foreign-made now.

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In its lawsuit, Florida wrote that the FDA has requested for a number of minor clarifications to the state’s proposal and alleged the company is “dragging its feet and protecting big pharmaceutical companies.”

“Given the near-universal support for programs like Florida’s, it seems the FDA’s reluctance to approve Florida’s SIP Proposal is a nod to the large pharmaceutical companies that oppose these importation programs because they yield increased competition and lower prescription drug prices,” the lawsuit reads.

The federal lawsuit, filed in Tampa, asks the courtroom to rule that the FDA and HHS have delayed Florida’s proposal and to power the businesses to make a dedication on the plan.

The drug trade foyer, Pharmaceutical Research and Manufacturers of America, which had opposed Florida’s importation plan as unsafe, didn’t instantly return an emailed request and voicemail looking for remark Wednesday.



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