FDA to Propose Tougher Rules for Outsourcing Drug Manufacturing

Publication: Wall Street Journal

Author: Alicia Mundy

06/15/2010 - The Food and Drug Administration said Monday it will propose stronger regulations for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of products made by contractors.

During a conference at Xavier University's Med-XU program on pharmaceutical global outsourcing, the FDA's Brian Hasselbalch said the agency may soon require companies to conduct on-site audits at outside contract manufacturing facilities, according to slides of his presentation. Currently, a company may review data about the quality controls, manufacturing analyses and product testing submitted by its contractor without performing a hands-on inspection.


Allan Coukell, head of a Pew Charitable Trusts program that tracks prescription drug safety problems, welcomed the FDA proposals. "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," he said. "Requiring companies to physically audit their suppliers and ensure the quality of drug ingredients would improve safety."

Read the full article, FDA to Propose Tougher Rules for Outsourcing Drug Manufacturing, on the Wall Street Journal Web site (requires subscription).

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