WASHINGTON—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.
Mr. Hasselbalch and Kathleen Culver, an official at the agency’s field office in Cincinnati, indicated that 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 drug-making standards, according to conference director Marla Phillips. She is founder of Med-XU, an initiative at the Cincinnati-based university that includes representatives of industry, regulators, medical researchers and corporate risk managers.
In the past three years, the FDA tripled the number of warning letters sent to contractors for violations of what the agency calls good manufacturing practices, while the citations against sponsors remained stable. During Monday’s conference, Mr. Hasselbalch and Ms. Culver discussed the possibility of sending more warning letters to sponsors for their contractors’ actions. One FDA slide read “Two for One,” meaning that for each manufacturing violation, warnings would go to both the contractor and the sponsor.
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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.”
A spokesman for Pfizer Inc., which outsources about 25% of its manufacturing, said the company hadn’t seen the FDA’s proposed regulation in detail yet. Ray Kerins said that Pfizer has “a rigorous system to ensure that all materials that go into our medicines meet both our high standards and all regulatory requirements. We only source from firms that meet our requirements. If they fail to do so we terminate our relationship with them.
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