The Florida House is expected Thursday to push forward with Gov. Ron DeSantis’ plan to create a state-backed prescription drug import program despite regulatory questions, possible legal challenges and increasingly heated opposition from the pharmaceutical manufacturing industry.
House Bill 19 was read for a second time on the House floor Wednesday and is cleared for a full chamber vote Thursday. If adopted, the bill would authorize the state’s Agency for Health Care Administration [AHCA] to create a drug import program even if it can’t implement it for at least a year, if ever.
A Senate version of the House bill – Senate Bill 1528 – was approved Tuesday in a 10-0 vote by the Senate Appropriations Health & Human Services Committee and awaits a final hearing before the Senate Appropriations Committee before being presented for a chamber vote.
HB 19, sponsored by Rep. Tom Leek, R-Ormond Beach, calls for the state to contract with pharmaceutical exporters in Canada and elsewhere to import FDA-approved, lower-cost prescription drugs.
The bill authorizes the Canadian Drug Importation Program managed by the AHCA to purchase drugs for Medicaid patients and prison inmates, and the International Drug Importation Program managed by the state’s Department of Business and Professional Regulation [DBPR] for individual residents to purchase drugs.
The Pharmaceutical Research and Manufacturers of America [PhRMA] issued a statement prior to Wednesday’s second reading of HB 19, calling the drug-importation program the “wrong approach.”
“This proposal jeopardizes the integrity of the closed U.S. prescription drug supply chain and the safety of Florida’s patients,” PhRMA maintains. “The biopharmaceutical industry is committed to bringing forward solutions that address the real challenges patients are facing with affordable access to medicines, and we welcome the opportunity to work with lawmakers in Florida on solutions that will help patients better afford their medicines and keep them safe from harm. This proposal cannot guarantee either.”
The Senate version of the bill differs in that it would establish one program to allow drug importation from Canada. It also requires that, after federal approval, the program come back to the Legislature for final approval before being implemented.
During Tuesday’s Senate Health & Human Services Committee hearing on SB1528, representatives of the pharmaceutical industry claimed importing prescription drugs from Canada and elsewhere could increase the amount of unsafe and counterfeit drugs.
PhRMA representative Mark Delegal said prescription drug prices can be lowered by more closely scrutinizing pharmacy benefit managers [PBMs] that don’t pass along savings and rebates to consumers.
“People are watching you,” Delegal told senators. “Counterfeiters are watching you. The public is watching you. And when you give a green light to this Canadian system, it’s going to change public conduct. They are going to go out and start saying, “Hey, this has been green-lighted.’ And all the counterfeiters will pop up and begin to make their products available.”
The senate panel approved two amendments to SB 1528, including one that deleted a proposal to require Canadian suppliers to export drugs “at prices that will provide cost savings to the state.”
Chairman Rep. Aaron Bean, R-Fernandina Beach, the bill’s sponsor, said the language was redundant and unnecessary.
But since the whole point of the program is to save money, Sen. Kathleen Passidomo, R-Naples, said citing its cost-savings would not be “redundant.”
Passidomo said she needs assurances that the drug-importation program "bears fruit” and doesn’t create opportunities for the “middleman.”
Even if adopted, it could take an estimated six months to a year for the drug import program to be approved by the U.S. Food & Drug Administration – if at all, considering U.S. Health & Human Services Secretary Alex Azar last year called state wholesale drug importation proposals “a gimmick.”
In introducing his proposal in February, however, DeSantis said he believes a provision in the 2003 Medicare Modernization Act allows for state drug importation programs, adding President Donald Trump was “enthusiastic” about the proposal.
On Monday, DeSantis was joined by Bean, Leek and AHCA Secretary-nominee Mary Mayhew in Sun City Center, a retirement community outside Tampa, to rally support for the proposal.