Ex-GSK General Counsel Acquitted By Judge Of Obstructing FDA Investigation

GREENBELT, Md. - (Mealey's) Former GlaxoSmithKline vice president and associate general counsel Lauren Stevens was acquitted by directed verdict May 10 of charges of obstructing a Food and Drug Administration investigation into the off-label promotion of the antidepressant drug Wellbutrin SR ( United...

Texas Risperdal Trial Ends When Janssen Settles For $158 Million, Company Says

AUSTIN, Texas -- Johnson & Johnson subsidiary Janssen LLP said Jan. 19 that it has agreed to pay $158 million to settle claims by Texas that it defrauded the Medicaid program through its off-label promotion of the atypical antipsychotic drug Risperdal ( State of Texas, ex rel. Allen Jones v. Janssen...

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to lexis.com subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending in the country. Not only did the court's 2-1 holding...

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance seeks to clarify and expand upon FDA's 2009 draft...