Florida Files 2nd Drug Import Suit Against FDA

Florida has filed a second suit against FDA charging the agency is violating the Freedom of Information Act (FOIA) by withholding records requested by the state relative to its application to permit the importation of Canadian drugs. The 4/21 suit says FDA violated the FOIA by not properly responding to a request for records about Florida’s Section 804 Importation Program (SIP) application that was filed in 11/2020, according to an online media report.

Florida reportedly wants to initially import drugs to treat conditions such as HIV/AIDS, hepatitis C, diabetes, and mental illness.

The suit says the state submitted a 3/21 FOIA request for a variety of records related to its SIP proposal and the SIP proposals submitted by Colorado, New Mexico, New Hampshire, Vermont, and Maine. FDA acknowledged the request but has not responded within legal timeframes, according to state officials.

“To date, FDA has not responded to the 3/2023 FOIA request, nor provided any responsive materials to that request, nor explained that responsive materials have been or will be withheld,” the suit says.

A 7/2022 suit also alleged violations of the FOIA and said FDA had violated the Administrative Procedures Act. It sought an order forcing the agency to immediately review and decide on the importation proposal.

In 11/2022, FDA asked for more information from Florida about its SIP proposal and on 4/7 asked for a stay of the 7/2022 suit because the agency had not received the requested information.

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

Florida’s response filed 4/21 charged FDA was asking 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. 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.”

In its 4/21 suit, Florida estimates it could save $150 million a year by importing cheaper drugs from Canada and said it has built a refrigerated distribution facility for the program and contracted with an importer and a distributor currently being paid $1.2 million per month.