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Feds push back in legal fight over Florida prescription drug importation

TALLAHASSEE, Fla. – The Biden administration asked a judge this week to dismiss allegations that the U.S. Food and Drug Administration “dragd its feet” over a Florida proposal to import prescription drugs from Canada and failed to properly comply with a public records request do not have.

US Justice Department lawyers filed a 27-page document pushing back against a lawsuit filed by the Florida Agency for Health Care Administration in August to try to prompt a decision on the importation proposal and obtain a range of records .

The document, a point-by-point response to the lawsuit, denied that the Food and Drug Administration had delayed action on Florida’s proposal under what is known as the Section 804 Importation Program, or SIP.

“Defendants deny the allegations that FDA was inactive with respect to, or ‘sat on,’ Florida’s SIP proposal and that FDA is denying access to prescription drugs,” said the document, filed Monday in federal court in Tampa .

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Gov. Ron 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 that managed 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, the lawsuit says.

The state submitted a proposal to the FDA in November 2020, which would have to approve the importation program. The FDA said in the filing Monday that it did not provide a timeline for deciding on Florida’s proposal and that “there is no express statutory deadline for approval of SIP proposals.”

Former President Donald Trump’s administration approved a rule in 2020 to help clear the way for drug imports, but groups including the Pharmaceutical Research & Manufacturers of America launched a legal challenge that remains unresolved in federal court in Washington.

In its lawsuit, the Agency for Health Care Administration said Florida’s effort to move forward with an import program is “stuck at the starting blocks.” The lawsuit also said it was “told that the FDA dragged its feet for so long” despite widespread public support for importing cheaper prescription drugs.

The state’s attorneys wrote that “it appears that the most likely explanation for the FDA’s delay, in light of near-universal support for import programs, is the FDA’s longstanding symbiotic relationship with large pharmaceutical companies that stand to lose hundreds of millions of dollars if Florida ‘s SIP proposal is approved.”

But the answer filed Monday said the defendants “deny the allegations that they are protecting the interests of pharmaceutical companies and delaying a ruling on Florida’s SIP proposal.”

The lawsuit alleges the FDA is violating a law known as the Administrative Procedure Act and seeks an order forcing the FDA to immediately review and rule on the proposal.

“This case involves the health and welfare of Floridians on a large scale,” the lawsuit said. “Florida is being forced to pay outrageous prices for critical prescription drugs for its neediest citizens. The FDA’s delay thus denies vulnerable Floridians access to essential medications at a reasonable cost. And the inability to recognize those cost savings comes at the expense of improved access to services for Medicaid recipients, children, and persons with disabilities or chronic conditions.”

The state is also seeking a declaration that the FDA violated the Freedom of Information Act when it failed to provide records requested on July 6 by Agency for Healthcare Administration Secretary Simone Marstiller.

However, the response filed Monday said the state does not “have the right to compel the production of records exempt from disclosure by one or more of the exemptions to the FOIA.”

The case was assigned to U.S. District Judge Thomas Barber, who was nominated to the bench by Trump.

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