State sues FDA over drug importation records

Gov. Ron DeSantis’ administration has filed a lawsuit alleging that the U.S. Food and Drug Administration has not complied with a public-records request about the state’s proposed program to import cheaper prescription drugs from Canada.

The lawsuit, filed Monday in federal court in Tampa, came after state Agency for Health Care Administration Secretary Simone Marstiller submitted a Freedom of Information Act request on July 6 seeking numerous records about drug-importation proposals by Florida and other states.

“FOIA (the Freedom of Information Act) requires the FDA (Food and Drug Administration) to process records requests and promptly provide the requested records or the reasonably segregable portion of records not subject to a FOIA exemption,” the 11-page lawsuit said. “The FDA has neither provided AHCA (the Agency for Health Care Administration) any responsive documents in response to its request, nor has the FDA claimed that any responsive records are exempt from disclosure. Therefore, the FDA’s failure to produce requested records or claim applicable exemptions violates FOIA.”

DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug-importation issue a priority in 2019, with lawmakers approving a plan to make imported drugs available in government programs such as Medicaid, the prison system and facilities run by the Department of Children and Families. At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS, hepatitis C, diabetes and mental illness, according to the lawsuit.

FDA officials would need to approve the importation program, and the state submitted a proposal in November 2020, the lawsuit said. The proposal has remained pending, with the state saying it has not received a timeline for a decision.

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 in federal court in Washington.

Marstiller’s July 6 request, in part, sought FDA records related to importation proposals by Florida, Colorado, New Mexico, New Hampshire, Vermont and Maine.

Other examples from the request include records “relating to the Canadian drug importation program and private pharmaceutical stakeholders, including pharmaceutical companies, lobbying groups, and advocacy groups;” records about standards for laboratory testing; and records “relating to the ‘risk’ to the American public’s health and safety.”

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Marstiller’s request, which was filed as an exhibit to the lawsuit, said the “records will shed light on the role of the FDA in implementing a program of great interest and importance to the people of Florida. The availability of essential, low-cost drugs is a matter of great public interest and concern in Florida and across America, especially because many vulnerable citizens need these drugs but cannot afford to pay for them. Moreover, the need for this information is urgent. Outpatient prescription drug prices have increased exponentially and continue to rise.”

The lawsuit briefly described steps Florida has taken to carry out the program but said it remains “stuck in the starting blocks” while waiting for an FDA decision.

“Florida is ready, willing, and able to begin operating the program immediately, having already built a refrigerated distribution facility and procured an approved importer and distributor currently being paid $1.2 million per month,” the lawsuit said.