Stryker Biotech Pleads Guilty, Will Pay $15 Million For Promoting Bone Repair Products

BOSTON - (Mealey's) Stryker Biotech LLC on Jan. 17 pleaded guilty to one federal misdemeanor count of misbranding a medical device and agreed to a $15 million fine for promoting the mixing of its OP-1 and Calstrux orthopedic repair products to health care professionals ( United States of America...

D.C. Circuit Says Former Purdue Pharma Execs Excludable But Questions Term

WASHINGTON, D.C. - (Mealey's) The Department of Health and Human Services is authorized to exclude three former Purdue Pharma executives from participating in federal health care programs, but it must explain why it thinks they should be excluded for 12 years, a fractured District of Columbia Circuit...

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...