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TALLAHASSEE, Fla. – The Biden administration this week asked a judge to reject allegations that the US Food and Drug Administration has “dragged its feet” on Florida’s request to import prescription drugs from Canada and failure to properly comply with a public records request.
Attorneys for the U.S. Department of Justice filed a 27-page document dismissing a lawsuit filed by the Florida Agency for Health Care Administration in August to try to force a decision on the application. import and receive series of records.
The document, a code-named response to the lawsuit, denied that the Food and Drug Administration had delayed processing Florida’s application under the so-called Section 804 Import Program, or SIP. .
“Defendants deny allegations that the FDA has been ineffective for, or ‘existed,’ Florida’s SIP application and that the FDA has not approved access to the drugs,” the the document, which was filed Monday in federal court in Tampa.
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Gov. Ron DeSantis and Florida House Speaker Jose Oliva, R-Miami Lakes, have made the issue of drug imports a priority in 2019, and lawmakers have agreed to a plan to funnel imported drugs into federal programs such as Medicaid, the prison system and facilities run by the Department of Children and Families. First, the government wants to import drugs to treat conditions such as HIV and AIDS, hepatitis C, diabetes and mental illness, according to the lawsuit.
The government submitted an application in November 2020 to the FDA, which must approve the import program. The FDA said in a release Monday that it had not given a timeline for a decision on Florida’s application and that “there is no statutory deadline for approving SIP applications.”
Former President Donald Trump’s administration approved a law in 2020 to help pave the way for drug imports, but groups including the Pharmaceutical Research & Manufacturers of America launched a legal challenge has yet to be resolved in federal court in Washington.
In its ruling, the Agency for Health Care Administration said Florida’s ability to move forward with the import program “is still at the starting blocks.” The lawsuit also said “the FDA has been dragging its feet for too long” despite overwhelming public support for importing cheaper drugs.
State attorneys wrote that “it appears that the most likely explanation for the FDA’s delay, before nearly universally supporting import programs, is the FDA’s symbolic relationship with the companies Big medicine could lose hundreds of millions of dollars if SIP of Florida. The proposal has been approved.”
But a response issued Monday said the lawmakers “deny allegations that they are protecting the interests of pharmaceutical companies and delaying a decision on Florida’s SIP proposal.”
The lawsuit alleges that the FDA is violating a law called the Administrative Procedure Act and seeks an order forcing the FDA to review and rule on the request.
“This case affects the health and well-being of Floridians on a large scale,” the lawsuit said. “Florida is struggling to pay high prices for prescription drugs for its sickest citizens. The FDA’s delay is therefore preventing vulnerable Floridians from having access to affordable prescription drugs. And it is not realizing those cost savings that come at the cost of better access to services for Medicaid recipients, children and people with disabilities and underlying conditions.
Also, the government is seeking a declaration that the FDA violated the Freedom of Information Act when it did not provide the records requested on July 6 by Secretary of Health Administration Simone Marstiller.
In a response issued on Monday, however, the government said “it is not necessary to compel the release of records exempted from disclosure by one or more exceptions to the FOIA”
The case has been assigned to U.S. District Judge Thomas Barber, who was nominated to the seat by Trump.
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