The Biden administration this week asked a judge to reject allegations that the U.S. Food and Drug Administration has “dragged its feet” on a Florida proposal to import prescription drugs from Canada and has not properly complied with a public-records request.
U.S. Department of Justice attorneys filed a 27-page document that pushed back against a lawsuit the Florida Agency for Health Care Administration filed in August to try to spur a decision on the importation proposal and to obtain a series of records.
The document, a point-by-point answer to the lawsuit, denied that the Food and Drug Administration has delayed action on Florida’s proposal under what is known as the Section 804 Importation Program, or SIP.
“Defendants deny the allegations that FDA has been inactive with respect to, or ‘sitting on,’ Florida’s SIP proposal, and that FDA is denying access to prescription drugs,” the document, filed Monday in federal court in Tampa, said.
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 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.
The state submitted a proposal in November 2020 to the FDA, which would need to approve the importation program. The FDA said in the filing Monday that it has not provided a timeline for deciding on Florida’s proposal and that “there is no express statutory deadline for authorizing 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 importation program “is stuck in the starting blocks.” The lawsuit also said it is “telling that the FDA has dragged its feet for so long” despite widespread public support for importing cheaper prescription drugs.
The state’s lawyers wrote that “it seems the most likely explanation for the FDA’s delay, in the face of near universal support for importation programs, is the FDA’s longstanding symbiotic relationship with big 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 contends the FDA is violating a law known as the Administrative Procedure Act and seeks an order forcing the FDA to immediately review and decide on the proposal.
“This case involves the health and welfare of Floridians on a grand scale,” the lawsuit said. “Florida is 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 is coming at the expense of improved access to services for Medicaid recipients, children, and persons with disabilities or chronic conditions.”
Also, the state is seeking a declaration that the FDA violated the Freedom of Information Act when it did not provide records requested on July 6 by Agency for Health Care Administration Secretary Simone Marstiller.
The answer filed Monday, however, said the state is not “entitled to compel the production of records exempt from disclosure by one or more of the exemptions to the FOIA”
The case has been assigned to U.S. District Judge Thomas Barber, who was named to the bench by Trump.