(The Center Square) – Florida’s proposed Canadian Prescription Drug Importation Program plan was submitted for final federal review and, as expected, was challenged immediately in court.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the Partnership for Safe Medicines and the Council for Affordable Health Coverage filed a lawsuit Monday challenging Florida’s drug import plan proposed under rules finalized by U.S. Department of Health and Human Services (HHS) Secretary Alex Azar in July.
The lawsuit argues there is not enough evidence to support assurances drug importation programs are safe or will produce significant cost savings for consumers. The plaintiffs also contend Azar’s decision to allow states to make those determinations is flawed.
“It is particularly disturbing that the administration is punting the responsibility for demonstrating safety and cost savings to state governments despite the clear requirement under federal law that the secretary of HHS must certify that imported drugs both pose no additional risk to public safety and will lead to significant savings for the American consumer,” PhRMA Executive Vice President and General Counsel James Stansel said in a statement.
After failing to dissuade lawmakers in a growing number of states from approving prospective pharmaceutical import programs, the pharmaceutical industry was expected to step up legal and political pressure at the federal regulatory and congressional levels once the momentum shifted to Washington, where the industry invests the lion’s share of its lobbying resources.
According to the National Institute on Money in Politics, the pharmaceutical industry contributed nearly $19 million to state elections in 2018 – one-third of the $56 million it spent on congressional campaigns.
Florida lawmakers in 2019 adopted House Bill 19, which created three state-backed programs to import cheaper prescription drugs. Establishing such a program was one of Gov. Ron DeSantis’ first announced priorities upon assuming office in January 2019.
HB 19’s three prescription drug importation programs are:
• The Canadian Prescription Drug Importation Program managed by the Agency for Health Care Administration (ACHA);
• The International Prescription Drug Importation Program managed by the Department of Business and Professional Regulation (DBPR);
• A pilot program run by the Florida Department of Health and the DBPR.
In 2020, lawmakers adopted House Bill 23, which creates an intergovernmental structure administered by the AHCA to purchase pharmaceuticals from Health Canada and earmarked $20.4 million in this year’s budget to hire a contractor to get the program off the ground.
The HHS and U.S. Food & Drug Administration (FDA) are expected to issue rules for state-backed imports from countries other than Canada on Nov. 30. That guidance will affect Florida’s prospective International Prescription Drug Importation Program.
Under the state’s final Section 804 Importation Proposal (SIP) plan, Floridians who need “maintenance medications” to help with “chronic health conditions,” such as asthma, COPD, diabetes and HIV/AIDS, will be among the first to benefit from the Canadian import program.
“For far too long Floridians have been paying exorbitant prices for prescription drugs,” DeSantis said Monday in a statement. “Today, we take another step toward lowering those prices by submitting a proposal to the U.S. Department of Health and Human Services for a first of its kind Canadian Prescription Drug Importation Program. My administration will continue to work collaboratively in an effort to bring affordable prescription drugs to all Floridians.”
“Today’s proposal submission is the result of bold leadership from Gov. Ron DeSantis and his continued efforts to make prescription drug prices affordable for Floridians,” AHCA Acting Secretary Shevaun Harris said. “I know that this crucial step Florida is taking toward effective change will be a catalyst for other states around the nation to follow. We will continue to work hard to bring down these prices that have burdened too many Floridians.”