Drugs

Florida Sues FDA Over Drug Importation Plan

The state of Florida has filed a lawsuit against FDA for failing to timely respond to a state-sought Freedom of Information Act (FOIA) request seeking information about why its and other states’ requests to begin importing prescription drugs from Canada have stalled at the agency.

A rule advanced by the Trump Administration allows states to implement import programs as long as FDA approves their programs. Several groups including the Pharmaceutical Research & Manufacturers of America have also launched a legal challenge to the importation program, which remains unresolved in federal court in Washington, DC.

“In the nearly two years while Florida’s SIP [Section 804 Importation Program] proposal has been pending, the FDA has asked for several clarifications and supplements but has provided no outward evidence of substantive progress towards approving the proposal,” the complaint says. “The FDA has also refused to provide a timeline for the approval process.”

The Florida complaint contends the state is ready, willing, and able to begin operating the program immediately, having already built a refrigerated distribution facility and retained an approved importer and distributor that are being paid $1.2 million per month.

Because FDA has not responded within FOIA’s statutory deadline, the state filed the lawsuit to compel the agency to respond to the FOIA request and provide the requested documents.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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