Drugs

Generic Drug Price-Fix Case Targets Teva as Bellwether

A Pennsylvania federal judge says that Teva will be the focus of the first trial over an alleged “overarching” industry-wide conspiracy to fix generic drug prices. Three other bellwether trials involving schemes to fix prices on three specific drugs will proceed on separate tracks, the judge said.

Bloomberg Law reports that the procedure will test the Teva case’s fitness for class action treatment on several individual drug conspiracies and explore the merits of an overarching conspiracy case.

The story reports that a sprawling multi-district lawsuit began with claims involving digoxin and doxycycline and has grown to include a wide range of suits involving 200 generic drugs and allegations of industry-wide conspiracies led by Heritage and Teva. “It now includes antitrust suits by healthcare companies, enforcement action by nearly every state attorney general, and proposed class actions on behalf of drug distributors, retail pharmacies, and payers such as insurers and pension funds,” Bloomberg says. “There’s also a separate federal price-fixing probe.”

Federal judge Cynthia Rufe rejected the drug companies’ argument in favor of starting with the Heritage case because the Teva case is “too massive and too complicated.” She said the industry proposal was not unreasonable, but she was not persuaded that it was a preferable way forward or that it would advance the litigation as effectively.

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