Prescription drug imports to Florida remain bottled up
Nearly three years after Florida lawmakers approved a plan to import cheaper prescription drugs from Canada, Gov. Ron DeSantis expressed frustration Tuesday that the plan remains stalled in Washington, D.C.
DeSantis and then-state House Speaker Jose Oliva, R-Miami Lakes, made the issue a priority in 2019, with lawmakers ultimately approving a plan to make imported drugs available in government-related programs.
Former President Donald Trump’s administration approved a rule in 2020 to help clear the way for imports, but groups including the Pharmaceutical Research & Manufacturers of America launched a legal challenge that remains unresolved.
During an appearance Tuesday in Jefferson County, DeSantis said the state has “worked really hard” on the issue.
“But this has been a long source of frustration, that this is something that just wasn't approved,” DeSantis said. “Because look, at the end of the day, you know, it would hurt some of the profits of Big Pharma. But you know, I'm much more worried about you being able to afford your medication, than I'm worried about Big Pharma, to be honest with you.”
DeSantis said he worked with Trump on the issue and that President Joe Biden indicated he wanted to move forward with drug importation. DeSantis on Tuesday criticized the U.S. Food and Drug Administration.
“The FDA has not done anything,” he said. “So, I can only construe that as meaning that they probably hope it just withers on the vine.”
But the lawsuit, filed by the Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines and the Council for Affordable Health Coverage, has moved slowly in U.S. district court in Washington.
Attorneys for the federal government filed a motion in August to dismiss the case, but the plaintiffs have argued against dismissal — with Florida playing a prominent role in the legal wrangling.
In the motion to dismiss, the federal attorneys argued that the plaintiffs had not been harmed by the 2020 rule and another type of approval known as a certification. The motion said Florida proposed a program — identified by an acronym as a “SIP” program — to import drugs but that it had not been approved.
“Authorization turns on a program’s initial (and sustained) ability to satisfy a host of stringent requirements related to patient safety and drug supply chain security, as well as to show significant cost savings to American consumers,” the motion to dismiss said.
“FDA possesses discretion to deny any proposal that does not facially meet these requirements. Even if a proposal appears to be complete, the agency still may withhold authorization — for example, if the proposal inadequately protects the public health or insufficiently demonstrates significant cost savings to American consumers. Unless and until FDA authorizes a SIP, neither the statute nor the implementing regulations impose any obligations.”
But in a Sept. 30 court document opposing dismissal, attorneys for the plaintiffs pointed to Florida’s proposal as they argued the case should be allowed to move forward The document said Florida “seeks to import approximately 100 drugs, the majority of which are manufactured under applications held by identifiable PhRMA (Pharmaceutical Research and Manufacturers of America) members.”
“Florida has appropriated millions of dollars to fund operation of the SIP,” the document said. “It has engaged a third-party logistics firm to carry out day-to-day operation of its proposed SIP, and it has retained a Canadian wholesale distributor to be the foreign seller. Florida Governor DeSantis has stated that the state is ‘ready to launch’ as soon as the FDA approves its SIP, promising that the state will begin importing drugs ‘within 90 days of approval.’”
In a friend-of-the-court brief filed last year, attorneys for the Florida Agency for Health Care Administration wrote that the state’s proposal “is initially targeted at providing safe and lower cost drugs for those Floridians who need maintenance medications for chronic health conditions such as asthma, COPD, diabetes, and HIV/AIDS. In particular, these drugs will assist Florida in meeting the needs of vulnerable populations who rely on the state for access to their drugs.”
The agency’s brief backed the challenged federal rule, saying lowering drug costs is a top concern of Americans.
“With the final rule … states and tribes have the ability to take lawful steps to lower drug costs,” the brief said. “At the same time, the final rule takes great care to make sure adequate safeguards are in place to make certain those imported drugs are safe.”