Outsourcing and Oversight: the FDA moves to tighten up drugmaker regs
The FDA will introduce stronger rules on safety and quality assurance for drug makers who outsource production, an agency official told 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, current good manufacturing practices (cGMPs) do not require companies to conduct on-site supplier inspections, and companies may rely instead on Certificates of Analysis – documentation submitted by a supplier containing safety, purity and quality data. This normally paper-based documentation can—and has been—easily falsified. Companies should be required to thoroughly assess ingredient suppliers before contracting (they’re not now) and conduct on-site audits of contracted suppliers (along the lines of FDA’s announced proposal). FDA should look at closing all these gaps, especially since the agency is currently unable to inspect all domestic and foreign manufacture sites.
The number of drug recalls related to manufacturing quality has spiked in recent years as more manufacturers struggle to guarantee the safety and quality of their products–a task made only harder by an increasingly splintered drug supply chain. The origin of the contaminated raw ingredients that FDA found at the McNeil plant in April has still not been revealed, nor has McNeil or Johnson & Johnson indicated they are investigating the raw material supplier.
“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.
–Kate Petersen, PostScript blogger