Drugs

Florida Amends FOIA Lawsuit Against FDA

Florida has amended a lawsuit against FDA charging the agency with 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 8/14 amended suit seeks FDA records, requested in a May FOIA filing, that were created after the initial 4/21 lawsuit was filed. The lawsuit says the agency 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. The amended complaint asks the court to compel FDA to respond to the May FOIA request.

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. In its 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.

A separate 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.

In June, the court issued a stay until 11/1 after FDA said it expects to decide by 10/31 whether to approve Florida’s importation plan. The stay relates to allegations by the state that FDA violated the Administrative Procedure Act (APA) in its consideration of the drug import proposal.

“Although the court understands plaintiffs’ desire to expedite the case,” said federal judge Thomas Barber, “the court notes that this case is currently set for trial in November. The potential for the APA claims to become moot upon a decision from FDA prior to trial weighs heavily in favor of staying the proceedings as to these claims to conserve judicial resources.” He reportedly added that the state and FDA should be prepared to go to trial in November if the claims aren’t resolved by then.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome