Growing scrutiny of pharma facilities exacerbating US drug shortage situation, claims Watson CEO

Intensifying regulatory inspections of pharmaceutical manufacturing facilities are causing record shortages of medicines, Paul Bisaro, Watson Pharmaceuticals chief executive and chairman of the US copy drugmakers body Generic Pharmaceutical Association (GPhA), told the Financial Times during this week’s US Food and Drug Administration public hearings on the country’s drug supply problems.

The GPhA has itself proposed multi-stakeholder collaboration to improve the situation, and the group’s chief executive Ralph Neas told an FDA workshop that the crisis is a complex issue (The Pharma Letter September 28).

Mr Bisaro, in comments to the FT, argued that the FDA is pushing generic suppliers to stop manufacturing of less profitable drugs altogether. He said some generics were supplied by a single manufacturer and the cost of inspections was leading to the closure of many plants. He cited the example of Teva Pharmaceutical Industries Irving, California, which made the anesthetic propofol but has now been closed due to the discovery of microbial infection problems and two other makers of the product are now struggling to meet demand.