Industry Group Prepares Another Lawsuit Against Florida’s Drug Importation Plan
09 Jan 2024
Patent Infringement
Pictured: Gavel with an assortment of tablets and capsules/iStock, Valerii Evlakhov
The Pharmaceutical Research and Manufacturers of America is preparing to lawsuit against Florida’s FDA-approved program to import prescription drugs from Canada. The development was reported by Endpoints News on Monday, citing an unnamed source familiar with the matter.
The industry group’s latest legal action comes after the FDA on Friday approved Florida’s Canadian Prescription Drug Importation Program, which will allow the state to import “certain prescription drugs” from Canada in an effort to lower prices for American consumers.
The program’s authorization will last for two years, starting from the date that the FDA is notified of the first imported drug shipment. As part of its obligations under the program, Florida’s Agency for Health Care Administration (AHCA) must ensure that the drugs it wants to import are authentic and comply with the FDA’s standards.
The AHCA should also relabel the drugs to be consistent with FDA-approved labelling and provide the FDA with a quarterly report containing information about the imported drugs, any potential safety and quality problems and cost savings generated through the program.
In its own statement, the office of Florida Governor Ron DeSantis said that the program is the first of its kind in the U.S. and will help the state save up to $180 million in just its first year of implementation. Florida will prioritize prescription drugs for chronic conditions, such as HIV, prostate cancer and mental illnesses.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs. It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma,” DeSantis said.
In a statement, Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), called the FDA’s approval of Florida’s importation plan “reckless” and said that the trade group is “deeply concerned” about its potential ramifications.
“Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” Ubl said.
Florida first submitted its proposal for the drug importation program in November 2020, seeking to lower the price of prescription drugs for Floridians. For three years, the FDA had delayed its decision on the matter, leading Florida in 2022 to sue the agency for allegedly dragging its feet on the program application.
PhRMA had also previously filed a lawsuit to block Florida’s importation program, but in February 2023, Judge Timothy Kelly of U.S. District Court of Columbia ruled that the industry group lacked standing, saying that the organization or its members do not face “concrete risk of harm from the inchoate importation program.”
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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