Drugs

Court Dismisses PhRMA Drug Price Suit

A California federal court has dismissed on procedural grounds a suit brought by Pharmaceutical Research and Manufacturers of America (PhRMA) seeking to block enforcement of California Senate Bill 17 that imposed notification and reporting requirements on drug manufacturers for certain price increases on their products sold to state purchasers, insurers, and pharmacy benefit managers in the state. Attorneys David Gibbons and Alan Kirschenbaum (Hyman, Phelps & McNamara) write in their firm’s FDA Law Blog that PhRMA challenged the law on three distinct constitutional grounds. The association says the law violates the Commerce Clause by regulating interstate commerce, violates the First Amendment by compelling manufacturers to speak and in a manner that expresses viewpoints that are not speaker- or content-neutral, and that the law is unconstitutionally vague.

The state argued that the court lacked subject matter jurisdiction under the Federal Rules of Civil Procedure and also said that PhRMA lacked standing to bring the suit and thus failed to state a claim upon which relief could be granted. The court agreed with California on both positions and thus dismissed the suit without ever reaching the constitutional questions PhRMA raised.

The suit was dismissed without prejudice and PhRMA was given 30 days to amend its complaint and include additional facts to address the procedural defects.

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