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From the Washington Post blog, The Checkup:

The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug’s approval. The letter does not bode well for the drug winning approval.

The move was expected, given that an FDA advisory panel had voted against the drug’s approval in July because of evidence it may have adverse side effects, including increasing the risks for birth defects during pregnancy.

But the step is the latest in a series of setbacks in the effort to develop new weight-loss drugs. The FDA last week rejected approval of lorcaserin because of it appeared to cause tumors in rats. And earlier this month the agency forced the removal of the the drug Meridia from the market because it appears to increase the risk for heart attacks and strokes.

Associated Press (via ABC): “NJ Jury Awards $25M to Ala. Man in Accutane Suit”

A New Jersey jury has hit the pharmaceutical company that makes Accutane with a $25.16 million judgment…

National Law Journal – “This Time Roche’s Loss to Accutane Suit Is Big, Real Big”

“This drug is awful, and the warnings were inadequate. [Roche] warned about things like pregnancy and those problems, but everything else they really ignored,” said Christopher Seeger of New York’s Seeger Weiss, one of four plaintiffs’ firms that is handling the scores of Accutane lawsuits. The others are Hook Bolton, Beggs & Lane, and Levin Papantonio — all in Pensacola, Fla.

New Jersey Law Journal – “In Retrial, N.J. Jury Awards $25 Million to Accutane User”

David Buchanan of Seeger Weiss in New York, one of the plaintiffs lawyers, says the reversal disappointed him at the time, but he was buoyed by the affirmance of Higbee’s other rulings. As a result, he says, the appeals court “provided a blueprint that will be useful in other trials.”

Buchanan says it is impossible to say for certain why the second jury returned so magnified a verdict after hearing the defense evidence the judge excluded at the first trial.

Two possible explanations: First, the first jury’s damage finding was lower than it should have been. “McCarrell’s case is one of the most serious,” he says. Second, the experience of the first trial has improved the plaintiffs lawyers’ presentations. “We’re getting better,” he says.

Buchanan says Tuesday’s verdict should send a message to the company that a settlement of pending cases would be wise. “I would hope they would acknowledge what the juries are telling them. I am hoping the message is heard.”

Law360 – “Roche Hit With $25M Accutane Verdict”

The nine-member jury found that Roche failed to provide an adequate warning to McCarrell’s prescribing physician about the risks of inflammatory bowel disease from Accutane and that that failure to warn was a “proximate cause” of McCarrell’s IBD, according to McCarrell’s lawyers.

On Monday, a nine-person New Jersey jury has found that pharmaceutical maker Hoffman-La Roche Inc. failed to provide an adequate warning of the possible condition to Andrew McCarrell’s prescribing physician, which then led to his development of chronic IBD. Mr. McCarrell, who was 23 at time he took Accutane, developed a severe case of IBD and later had his colon removed. The jury awarded compensatory damages of $25.16 million to Andy, now in his thirties.

Hoffman-La Roche faces as many as 800 cases around the country. Seeger Weiss has won 5 consecutive verdicts against Roche since 2005.