The QMN Weekly Bulletin

FDA Needs to Shift Import Safety Burden to Industry, Autor Says

March 16, 2012

As global pharmaceutical trade grows, the FDA’s model of surveillance needs revamping, including placing the burden on the drug industry to prove a product is safe before it enters the U.S., an FDA official says.

For now, the agency must prove a product is adulterated before it can stop shipments. With two thirds of drug production now outside the country, “it just doesn’t make sense to say that FDA … must show there’s something wrong with the product in order to do that,” said Deb Autor, deputy commissioner for global regulatory operations and policy.

The average manufacturer now contracts with 35 suppliers for a single product and “we can’t be there everywhere all the time, so we need to be strategic in thinking about these things,” she said. Creating good importer practices for companies and creating a track-and-trace system would help strengthen the supply chain, Autor added. 

The FDA needs cooperation from drugmakers to realize its goals, and industry could benefit through incentives for good manufacturing practices. Compliant drugmakers could see fewer inspections, Autor said. Drugmakers may also see more streamlined regulations and gain a competitive advantage when non-compliant companies are nabbed. 

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