Recent Posts

Ex-GSK General Counsel Acquitted By Judge Of Obstructing FDA Investigation
Posted on 10 May 2011 by Tom Moylan

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... Read More

Texas Risperdal Trial Ends When Janssen Settles For $158 Million, Company Says
Posted on 19 Jan 2012 by Tom Moylan

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... Read More

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns
Posted on 28 Mar 2014 by William A. Ruskin

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... Read More

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution
Posted on 14 Dec 2012 by William A. Ruskin

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending... Read More