Just when lawmakers, lobbyists, and public relations firms thought that the last weekend before the 2023 legislative session would be a quiet and uneventful one—the calm before the storm, if you will— Senator Jason Brodeur threw a monkey wrench into their weekend plans. On Friday, Sen. Brodeur filed Gov. Ron DeSantis’s much-anticipated 43-page “Prescription Drug Reform Act” (S 1515) measure on everyone's lap.
Sen. Brodeur's bill will arguably be one of the most consequential pieces of legislation that Gov. DeSantis will tackle during the legislative session.
This past January, Gov. DeSantis stated that he was going to address the high cost of prescription drugs by proposing legislation to limit drug middlemen or pharmacy benefit managers (PBMs), from driving up the cost of prescription drugs.
As we mentioned before, Governor DeSantis dropped an anvil on the pharmacy benefit manager (PBM) lobby when he announced he would pursue cost-cutting legislation.
Now, that the bill is filed, pharmaceutical companies are trying to make sense of it all.
"These reforms will enhance transparency and reduce the influence of pharmacy middlemen, which will help consumers as well as our small pharmacies,” said Governor Ron DeSantis. “I look forward to these reforms becoming law.”
Well, those reforms are now on paper and will make its way through the legislative process before lawmakers vote on the drug cost-cutting measure.
Florida State Surgeon General Dr. Joseph Ladapo blamed ‘Big Pharma’ of lining its pockets, and causing the hike in prescription drug prices.
“The American people have been led to believe that drug costs are high so that pharmaceutical companies can continue to perform research,” said State Surgeon General Dr. Joseph Ladapo. “But this claim ignores the fact that pharmaceutical research and innovation tends to begin in universities, mostly through NIH funding. That’s our tax dollars. The American people deserve affordable prescriptions, not unnecessary mark-ups that continue to line the pockets of Big Pharma.”
As interested parties are feverishly mulling through the 43-page bill, the Florida Senate posted this quick summary of what the bill calls for.
Prescription Drugs; Citing this act as the "Prescription Drug Reform Act"; specifying additional prohibited acts related to the Florida Drug and Cosmetic Act; requiring certain drug manufacturers to notify the Department of Business and Professional Regulation of reportable drug price increases on a specified form on the effective date of such increase; requiring such manufacturers to submit certain reports to the department by a specified date each year; providing requirements for certain contracts between a pharmacy benefit manager and a pharmacy benefits plan or program or a participating pharmacy; requiring the office to review certain referrals and investigate them under certain circumstances, etc. APPROPRIATION: $1,500,000
As the summary mentions, the bill includes “prohibited acts” by an individual. Here are just a few of these acts:
(1) The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.
(2) The adulteration or misbranding of any drug, device, or cosmetic.
(3) The receipt of any drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of such drug, device, or cosmetic, for pay or otherwise.
(4) The sale, distribution, purchase, trade, holding, or offering of any drug, device, or cosmetic in violation of this part.
(5) The dissemination of any false or misleading advertisement of a drug, device, or cosmetic.
(6) The refusal or constructive refusal:
(a) To allow the department to enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held;
(b) To allow inspection of any record of that establishment;
(c) To allow the department to enter and inspect any vehicle that is being used to transport drugs, devices, or cosmetics; or
(d) To allow the department to take samples of any drug, device, or cosmetic.
(7) The purchase or sale of prescription drugs for wholesale distribution in exchange for currency, as defined in s. 560.103.
(8) Committing any act that causes a drug, device, or cosmetic to be a counterfeit drug, device, or cosmetic; or selling, dispensing, or holding for sale a counterfeit drug, device, or cosmetic.
More on this bill in the days to come.