Drugs

FDA ‘Equitable Remedy’ Authority in Doubt: Attorneys

FDA’s authority to obtain equitable remedies in injunction suits may be in jeopardy in light of federal court questions in a Federal Trade Commission (FTC) case against Shire. Attorneys Jennifer Thomas and John Fleder (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that the Shire case looks at FTC’s statutory authority to bring suit in federal court seeking injunctive and equitable relief where the alleged statutory violations have long since ceased. They say that while it is hard to predict how a case will be decided, questions by judges at an appeals court hearing “suggested the odds are leaning heavily against FTC winning.”

If FTC does lose the Shire case, they say, it will raise questions about other FTC enforcement cases and also about whether FDA has the authority to seek equitable remedies when it pursues injunctive relief in court.

Thomas and Fleder say a provision in the law authorizes courts to “restrain violations” of the Federal Food, Drug, and Cosmetic Act, but is silent on the court awarding equitable relief as part of the injunction. They say the question of FDA’s authority to seek restitution under such a proceeding was hotly debated 15 years ago. In some court decisions, FDA’s authority was upheld, they write, and the agency also has successfully received such equitable relief through consent decrees.

The attorneys say they will continue to monitor the developing case law.

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