Corporate News: FDA Weighs Stiffer Rules
WASHINGTON -- The Food and Drug Administration said Monday it will propose stronger regulations for drug companies that outsource manufacturing, putting more responsibility on them to ensure the purity and safety of products made by contractors.</br></br>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.</br></br>Mr. Hasselbalch and Kathleen Culver, an official at the agency's Cincinnati office, indicated the agency wants to hold sponsor companies more accountable for flaws in manufacturing processes of outside contractors both in the U.S. and abroad, and for certifying that contractors have followed FDA standards, according to conference director Marla Phillips.</br></br>An FDA representative and Mr. Hasselbalch couldn't immediately reached for comment.</br></br>Credit: By Alicia Mundy