Drugs

Pay-for-delay Settlements Drop Substantially: FTC

The Federal Trade Commission says drug companies are entering into substantially fewer pay-for-delay patent dispute settlements than they were engaging in three years ago. According to a new FTC staff report, the follows a landmark Supreme Court antitrust decision in FTC v. Actavis in 2013. “The total number of such deals filed with the FTC has dropped to 21 in FY 2014 from 29 in FY 2013, and 40 in FY 2012 prior to the Actavis ruling,” it says.

In Actavis, the high court held that a branded drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate U.S. antitrust laws. “Also since the Actavis decision, the FTC announced a $1.2 billion settlement resolving its antitrust suit against Cephalon, Inc. for allegedly illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil,” the agency says.

According to the staff report, while the number of filed settlements increased slightly – 160 in FY 2014 as opposed to 145 in FY 2013 – the number of potential pay-for-delay agreements decreased. “Twenty-one of the settlements in FY 2014 potentially involve pay for delay because the brand manufacturer compensated the generic manufacturer and the generic manufacturer was restricted from marketing its product in competition with the branded product for some period of time,” it says. According to the report, more than 80% of patent disputes involving potential generic drug competition were resolved without compensation to the generic manufacturer or without restrictions on generic competition.

For more analysis, visit FTC’s blog posting “Is FTC v. Actavis Causing Pharma Companies to Change Their Behavior?”

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