A federal lawsuit filed in Washington, D.C., by a trade association of pharmaceutical manufacturers could obstruct an effort by Florida officials to get federal approval to import drugs from Canada at lower costs.
The Pharmaceutical Research and Manufacturers of America is among the groups suing the federal Department of Health and Human Services (HHS) and its secretary, Alex Azar II, over an HHS initiative to allow pharmacists and wholesalers to import prescription drugs from Canada. The complaint filed in federal court in the District of Columbia on Nov. 23 contends the new HHS rule presents safety risks to Americans and violates federal law.
“In light of the risks inherent in importation outside the drug manufacturer’s control and the likelihood that such importation would yield little to no savings for American consumers, HHS secretaries of both political parties have consistently declined for nearly two decades to certify importation,” the complaint states.
Florida Gov. Ron DeSantis announced last month that the state has filed its importation proposal with HHS to import drugs from the nation’s northern neighbor, arguing that the program would give Floridians relief from paying exorbitant prices for the drugs they need. The state legislature last year worked with the governor to move forward on the program to lower drug prices for millions of Florida residents.
A spokeswoman for DeSantis told the Florida Record in an email that the governor remains committed to launching a safe, effective importation program for pharmaceuticals in spite of the lawsuit filed last month.
“While the state of Florida appreciates the good work being done by pharmaceutical companies on therapeutics and vaccines to fight the COVID-19 pandemic, this lawsuit is nothing more than an attempt by Big Pharma to block the advancement of a program that will help ensure access to more affordable prescription drugs for Americans,” Meredith Beatrice said in the email.
The HHS final rule for the importation initiative was approved on Nov. 30. Florida’s proposal under that rule aims to start off by importing a handful of drug classes to benefit those with chronic medical conditions, such as obstructive pulmonary disease, asthma and diabetes.
The Florida Agency for Health Care Administration plans to contract with a vendor to manage the importation program so that it complies with all relevant state and federal statutes, according to a news release from the Governor’s Office.
In their lawsuit, the drug makers are urging the district court to permanently enjoin certification of the importation rule.
“There is no indication that the final rule will reduce costs to actual American patients,” the complaint says. “Furthermore, aspects of the final rule are contrary to the FDCA (Food, Drug and Cosmetic Act), violate manufacturers’ First Amendment rights and raise serious questions under the Fifth Amendment Taking Clause.”