Feds put GSK manufacturing under supervision 2 years ago

While U.S. authorities earlier this week made a big splash over the $3 billion agreement with GlaxoSmithKline ($GSK) to settle a wide variety of claims that it used misleading marketing and bribes to sell products, it turns out the company has for two years been hewing to a part of the deal that covers the way its manufacturing operates. Buried as Appendix D of the Corporate Integrity Agreement released Monday were provisions that require a manufacturing overlord and provisions that the board of directors attest to Health and Human Services that the company is meeting FDA current good manufacturing practices. The provisions come out of a whistleblower lawsuit settled in 2010 with former quality assurance manager Cheryl Eckard over an ugly set of claims about how it made drugs at its Cidra, Puerto Rico plant. The facility was shuttered in 2009. Eckard's attorney, Lesley Ann Skillen with Getnick & Getnick, points out that the company first tried to hide Eckard's disclosures. The company not only ended up paying $750 million in fines and penalties, it now has its manufacturing practices globally being scrutinized by the HHS inspector general. The lesson for its peers, Skillen says: "ignore whistleblowers at your peril." Story | More