Florida expands FDA lawsuit regarding imported prescription drugs, citing additional neglected information requests

by | Aug 14, 2023

  • Florida broadened its existing lawsuit against the FDA on Monday, alleging that the agency inadequately addressed public information requests.
  • The Florida Agency for Health Care Administration (AHCA) submitted a Freedom of Information Act (FOIA) request in May, aligning with previous requests but encompassing more recent information.
  • Florida asserts that the FDA did not meet the legally required response time for the May FOIA Request.
  • Consequently, the plaintiffs amended their complaint to compel the FDA’s response within the ongoing legal context of the Canadian Prescription Drug Importation Program.

The state of Florida expanded an ongoing lawsuit on Monday, filing a revised challenge against the Food and Drug Administration (FDA) that alleges the agency failed to adequately provide public information requests earlier this year.

Per the amended complaint, the Florida Agency for Health Care Administration (AHCA) submitted a Freedom of Information Act (FOIA) request in May, which was filed in similar scope to previous FOIA requests made in July 2022 and March 2023 but covered a more recent timeframe.

The state contends that the FDA did not respond to the May FOIA Request within the required statutory timeframe. As a result, the plaintiffs amended their complaint to compel the FDA to respond as part of the ongoing legal proceedings regarding the Canadian Prescription Drug Importation Program.

“The FDA has acknowledged receiving the May 2023 FOIA Request but has not responded within FOIA’s statutory deadline,” reads the legal document.

The plaintiffs are seeking relief from the Court, requesting declarations that the FDA violated FOIA by failing to determine and provide records for the FOIA requests from March and May. Within the complaint, the state is additionally requesting the Court to order the FDA to conduct a search for relevant records, provide determinations, and disclose responsive documents while concurrently seeking the award of attorneys’ fees and costs, as well as any other appropriate relief.

Gov. Ron DeSantis announced last August that his administration filed a lawsuit against the FDA in response to an alleged delay of 630 days in approving Florida’s proposal for its Canadian Prescription Drug Importation Program. If importation rights are granted, it is expected to lower the cost of consumer medication for residents of participating states.

The lack of response resulted in a lawsuit against the Food and Drug Administration, asserting that the agency has “intentionally delayed the process of approval.”

The federal government denied the claim, going so far as to ask a judge to reject allegations, as well as file a 27-page document that pushed back against the lawsuit.

“Defendants deny the allegations that [the] FDA has been inactive concerning, or ‘sitting on,’ Florida’s SIP proposal, and that [the] FDA is denying access to prescription drugs,” the document reads, filed in a federal court in Tampa.

In December, New Hampshire, New Mexico, and Colorado formally joined Florida in requesting federal permission to import prescription pharmaceuticals.

A policy to establish a foundation for medicinal imports was authorized by the administration of Former President Donald Trump in 2020, but organizations like the Pharmaceutical Research & Manufacturers of America mounted a legal challenge that is still pending in federal court in Washington.

Kaiser Health News reports that Health and Human Services Secretary Xavier Becerra said on Dec. 5 that the Biden administration welcomed applications for drug importation programs from Colorado and other states, but would not pledge that the FDA would rule on any application in 2023.

State officials project that the initiative, which was originally introduced by DeSantis and the state Legislature in 2019, will save the state between $80 and $150 million in its first year alone.

If authorized, imported pharmaceuticals would be made available through government programs including Medicaid, the penal system, and institutions managed by the Department of Children and Families, according to a plan designated by state authorities.

At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS, hepatitis C, diabetes, and mental illness.

“For far too long, Floridians have been paying exorbitant prices for prescription drugs,” said DeSantis. “My administration will continue to work collaboratively to bring affordable prescription drugs to all Floridians.”


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