Feds push back on legal fight against importing prescription drugs into Florida

TALLAHASSEE, Florida. – The Biden administration this week asked a judge to throw out allegations that the U.S. Food and Drug Administration “dragged its feet” on a Florida proposal to import prescription drugs from Canada and not failed to properly comply with a request for public records.

Lawyers for the US Department of Justice filed a 27-page document that pushed back against a lawsuit filed by the Florida Agency for Health Care Administration in August to try to push for a decision on the proposal import and get a series of documents.

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

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

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

The state submitted a proposal in November 2020 to the FDA, which is expected to approve the import program. The FDA said in the filing on Monday that it did not provide a timeline for deciding on Florida’s proposal and that “there is no express statutory time limit for allowing SIP proposals.”

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

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

State attorneys wrote that “it appears that the most likely explanation for the FDA’s lag in the face of near-universal support for import programs is the FDA’s longstanding symbiotic relationship with large corporations. pharmaceutical companies that stand to lose hundreds of millions of dollars if Florida’s SIP proposal is approved.

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

The lawsuit argues that the FDA violates a law known as the Administrative Procedure Act and seeks an order requiring the FDA to immediately review and decide on the proposal.

“This matter involves the health and welfare of Floridians on a large scale,” the lawsuit said. “Florida is forced to pay exorbitant prices for essential prescription drugs for its most needy citizens. The FDA delay thus deprives vulnerable Floridians of access to essential medicines at a reasonable cost. And the failure to recognize these cost savings comes at the expense of better access to services for Medicaid recipients, children, and people with disabilities or chronic conditions.

In addition, the state is seeking a statement that the FDA violated the Freedom of Information Act when it failed to provide records requested on July 6 by the Agency’s Secretary of Administration for health care, Simone Marstiller.

The response filed Monday, however, said the state was not “entitled to compel the production of documents exempt from disclosure by one or more of the FOIA exemptions.”

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

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