Drugs

Ranbaxy Racketeering Suit Should Continue: Judge

A Massachusetts federal magistrate judge has recommended that a class action suit alleging anticompetitive and racketeering behavior by Ranbaxy and Sun Pharmaceuticals before the entry of two generic drugs on the market should not be dismissed. The complex suit raises issues not tried before and thus there was little precedent to guide the magistrate judge in making his recommendation.

A footnote to the judge’s report quotes the companies’ attorney as saying that “the reason there isn’t a lot of precedent is I don’t believe anyone has ever taken a case of fraud on the FDA and tried to package it as an antitrust case.” And the plaintiffs’ counsel said this type of case hasn’t been brought before but “these facts are pretty rare. FDA hasn’t had to come down on a manufacturer like this ever before … with respect to good manufacturing practices … the kind of misconduct that would happen here hasn’t happened before.”

In a 54-page opinion, the judge goes into a detailed discussion of the FDA generic drug regulatory process and the many issues the agency has had with Ranbaxy. It discusses the company’s efforts in the late 1990s and 2000s to file many ANDAs to obtain 180-day marketing exclusivity as the first filer. Included in those filings were the ANDAs for Diovan and Valcyte that are the subject of the suit.

While the companies asked to have the suit dismissed, the magistrate judge found that the plaintiffs had raised enough antitrust and racketeering issues for it to proceed.

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