Drugs

Charges Likely in Generic Drug Cases: Bloomberg

Bloomberg News says that sources close to an almost four-year criminal investigation into alleged price-fixing by generic drug makers have indicated that at least two companies are likely to be indicted within coming months, in addition to several executives. The sources also said that another company could agree to plead guilty before the charges are filed. Bloomberg says the charges would mark a major breakthrough in the investigation that began in 2014 under the Obama administration and has spread to nearly every major generic drug manufacturer.

As part of the investigation, Bloomberg reports, federal authorities have raided at least two companies — Perrigo and Mylan.

“The Justice Department hasn’t announced any developments in the case, and no charges have been disclosed against any companies or individuals since two former executives of Heritage Pharmaceuticals were charged with colluding with other companies in 12/2016 and pleaded guilty,” the news service says. “In that case, the former CEO and the former president of Heritage conspired to fix prices and divide customers for an antibiotic, doxycycline hyclate, and for glyburide, a medicine used to treat diabetes, according to the Justice Department.”

The looming charges involve fixing prices and dividing the market, according to Bloomberg’s sources. In addition to the criminal case, generic drug manufacturers also are facing a civil complaint filed by state attorneys general led by Connecticut. That case accuses more than 12 companies of conspiring to raise prices on 15 drugs.

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