For the past few years, the US pharmaceutical industry has been dragged across hot coals because of its marketing and sales practices. Misbranding or misrepresenting violations continue to erupt but another risk is rapidly taking over the headlines, court dockets and public opinion about our industry.
Good Manufacturing Practices (GMP) violations have become the new healthcare fraud as the Department of Justice (DOJ) tests out new legal theories under the False Claims Act (FCA). The Food and Drug Administration (FDA) has dusted off its regulatory authority to prosecute GMP violations. After blistering reports by government agencies, the FDA has ramped up inspections of domestic and foreign pharmaceutical plants - brand, generic, contract and Active Pharmaceutical Ingredient (API) - both in frequency and depth. And just to cement the growing public and legislative distrust of drug quality and safety, massive recalls have kept quality problems in the headlines and on the minds of millions of patients.