U.S. v. Barr Labs

Executive Summary

Trial suspended on Aug. 19 while FDA and the generic manufacturer negotiate a settlement. In an Aug. 17 opening statement in Newark federal court, attorneys for FDA asked the court to demand a halt in the manufacturing of 15 products, improvements in Barr's production methods and process testing for 45 other products and the recall of 30 lots of products due to "egregious" cGMP violations. Attorneys for Barr, who had expected the government to seek a total shutdown of the generic firm, told the court that Barr is "prepared to make any reasonable accommodation to the government".