FDA weighs stricter outsourcing standards
Caution: New outsourcing rules ahead. The FDA is planning to float stepped-up regulations for drugmakers that farm out their manufacturing, the Wall Street Journal reports, in an attempt to hold the companies more accountable for any product flaws.
FDA's Brian Hasselbalch told attendees at an outsourcing conference that the agency may start requiring companies to check out their contractors' facilities in person, rather than just reviewing data on paper. The agency is also mulling the prospect of issuing warning letters to drugmakers as well as their contractors when manufacturing problems are found. Now, those warnings usually go only to the contractors.
"They want sponsors to see contractors as an extension of their own company," Marla Phillips, who directed the Med-XU conference, told the WSJ. And the idea cheered experts who keep an eye on drug safety: "Requiring companies to physically audit their suppliers and ensure the quality of drug ingredients would improve safety," said Allan Coukell of the Pew Charitable Trusts. What do you think?
- read the WSJ story