Florida and FDA Clash Over Drug Importation Regulations

A plan to import less expensive prescription medications from Canada was approved by Florida lawmakers four years ago, but it is now bogged down in legal conflicts between the state and the U.S. Food and Drug Administration.

In a complaint filed on Friday, the state claimed that the Food and Drug Administration had broken the Freedom of Information Act by failing to adequately reply to a request for information regarding Florida’s attempt to obtain clearance for the importation program.

In July, the state also brought a related federal action, which is still pending.

With lawmakers approving a plan to make imported drugs available in government programs like Medicaid, the prison system, and facilities run by the Department of Children and Families, Gov. Ron DeSantis and former Florida House Speaker Jose Oliva, R-Miami Lakes, made the drug importation issue a priority in 2019. According to court filings, the state initially seeks to import medicines to treat diseases like HIV and AIDS, hepatitis C, diabetes, and mental illness.

The Food and Drug Administration, which would need to approve the importation scheme, received a request from the state in November 2020. The plan is covered by the government SIP or Section 804 Importation Program.

According to the lawsuit filed on Friday, the state requested several pieces of information from the federal agency under the Freedom of Information Act on March 21. These records included those pertaining to Florida’s SIP proposal as well as those made by Colorado, New Mexico, New Hampshire, Vermont, and Maine.

Attorney General Ashley Moody’s legal team claimed in a letter that while the federal agency had accepted the documents request, it had not fully complied with the legal deadlines.

“To date, the FDA has not responded to the March 2023 FOIA Request, nor provided any responsive materials to that request, nor explained that responsive materials have been withheld or will be withheld,” the lawsuit claimed.

Florida-FDA Spar Over Drug Importation

Similar claims of Freedom of Information Act abuses were made in the July case. Additionally, the state demanded a court order compelling the FDA to review and rule on the proposed medicine importation quickly on the grounds that the FDA had broken the Administrative Procedure Act.

In November, the FDA asked the state for more details regarding the SIP proposal. Because the Food and Drug Administration had not yet received the needed material, US attorneys requested a stay of the July lawsuit on April 7.

“This stay would respect Florida’s stated intention to provide the requested materials and afford FDA the necessary time to review those materials,” the motion read. “FDA would provide the court with a status report about the anticipated decision-making timeline for Florida’s updated SIP proposal at the conclusion of the stay period.”

However, the state retaliated against the stay request and claimed it had submitted a supplement SIP plan in a court filing on Friday.

“Defendants ask the court to establish a precedent that agencies can delay indefinitely until sued, then rush out a lengthy and largely contrived request for information to stall the case and give the appearance of agency action, then obtain a stay of judicial proceedings on the basis that the agency hasn’t yet received a response to its enormous request — all designed to further delay an adverse judgment,” the state’s lawyers wrote. “Allowing agencies to engage in such gamesmanship undermines the judicial review mandated by Congress in the Administrative Procedure Act and creates a moral hazard for agencies.”

Thomas Barber, a U.S. District Judge in Tampa who was chosen by former President Donald Trump for the federal bench, is in charge of both cases.

The state claimed in the complaint that it could save $150 million annually by importing less expensive medications from Canada. Additionally, it claimed to have partnered with an importer and a distributor “currently being paid $1.2 million per month” and established a refrigerated distribution facility for the scheme.

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