(The Center Square) — Gov. Ron DeSantis and his administration are currently locked in an ongoing legal battle with the U.S. Food and Drug Administration after the agency stalled efforts by Florida to get cheaper prescription drugs abroad.
The U.S. District Court for the Middle District of Florida will hold a hearing on the lawsuit on May 31 to hear arguments on the state’s challenge to an order from Magistrate Judge Julie Sneed that curtailed the state’s 42 requests for information through the discovery process. The state says that the federal government is using stalling tactics and impeding requests for information. The feds say in a filing that they’ve already complied with an earlier order on information requests, including releasing a 4,616-page administrative record on December 29, 2022.
DeSantis and the state’s Agency for Health Care Administration have made lowering prescription drug prices a priority. In November 2020 the state filed a Section 804 Importation Program proposal to the FDA to get final approval to start importing from foreign markets like Canada.
Almost two years later in August 2022, DeSantis announced that he had filed a lawsuit against the FDA for what he called a reckless and unreasonable delay, and noted that 630 days had lapsed since filing the original proposal.
DeSantis stated the delay was “bureaucratic roadblocks” and that the Biden administration lacked transparency in its approval process after Donald Trump’s administration had previously approved a similar measure to import foreign prescription drugs in 2020.
“The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation. Florida is confident in our importation model, and we continue to look for more ways to lower drug costs for Floridians while the FDA delays approval of this importation proposal,” DeSantis said in a news release about the lawsuit.
In the August 2022 complaint, DeSantis’ legal team argued that American prescription drugs cost 218% more than their Canadian counterparts, and in some cases, life-saving medications can cost more than $300 per pill. This can put a significant strain on the health care budget. The lower-cost drugs were to be used for HIV treatments, diabetes, hepatitis C and mental illness.
The complaint goes on to say that Florida could save up to $150 million per year once fully implemented and added that the program is “stuck in the starting blocks” because the FDA had yet to approve the program. The FDA had also not shown any progress in approving the program and the case remains unresolved.
In response to a Freedom of Information Act request by the AHCA in July 2022 to check the status of the proposal, the FDA stated that they had yet to fill the state’s request because of an increase in requests.
The agency stated that it could take anywhere from 18 months to 24 months to process the request, and the agency was unable to give a timeline for when it would be done. Another FOIA request was made in March 2023 and the FDA has not responded.
A similar lawsuit was again filed in April 2023 after the FDA had requested additional information from the state about the SIP proposal. The agency had asked for a stay on previous lawsuits because the state had not provided the requested information.
The state’s legal team argued in the complaint that the request for a stay was a way to further delay progress.
Despite delays, Senate Bill 1550 — the Prescription Drug Reform Act — sponsored by Sen. Jason Brodeur, R-Lake Mary, was signed into law by DeSantis in April, and removes red tape and bureaucracy from the health care industry that is driving up prescription drug prices.
At the bill signing, DeSantis stated that it is the interests of big pharmaceutical companies that are a priority for the Biden administration and the FDA. The Biden administration denied delaying the program.
This article First appeared in the center square