Loss of Credibility Brings Down OTC Firm That Doctored Stability Data

The fall of Leiner Healthcare Products is the cautionary tale of how an FDA inspection uncovered widespread data manipulation at a major OTC generic drug maker, leading in less than 18 months to bankruptcy in a case reminiscent of the Able Labs collapse two years ago. Along the way, investigators learned why Leiner’s internal investigation had been turned over to HR, and why Pfizer terminated its contract with Leiner. A massive house-cleaning that started with ethics training came too late to save the company.