Wall Street Journal: FDA will propose stronger rules on outsourced drug making

06/15/2010

The FDA will introduce stronger rules on safety and quality assurance for drug makers who outsource production, an agency official said at an industry conference this week.

According to the Wall Street Journal, the agency said it will likely soon “require companies to conduct on-site audits at outside contract manufacturing facilities,” whether domestic or foreign. Right now, a contractor may submit to a company safety and quality data without any onsite inspection by the drugmaker. The number of drug recalls has spiked in recent years, suggesting that in an increasingly splintered drug supply chain, manufacturers are having trouble guaranteeing the safety and quality of their products.

"Outsourcing by drugmakers and the increased reliance on contractors, especially those based in developing nations, clearly puts consumers at risk of contaminated or substandard drugs," Pew Prescription Project director Allan Coukell told the Journal. "Requiring companies to physically audit their suppliers and ensure the quality of drug ingredients would improve safety."

For more, go to the Pew Prescription Project’s page on securing a safe drug supply.