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Globalization one of FDA's emerging trends

Pharma Compliance Alert, September 17, 2008

The number of drug products manufactured overseas and the numbers of sites that manufacture drug products more than doubled since 2001. Conversely, the number of FDA inspections remained the same.

“The FDA alone cannot police the world,” says Deborah Autor, director of the Center for Drug Evaluation and Research’s office of compliance during the Regulatory Affairs Professionals Society annual conference in Boston Monday, September 15.

She recommended pharmaceutical companies implement corporate accountability all along the supply chain to ensure quality and safety. Autor says companies should monitor where and under what conditions products are manufactured.

“We’re at a point where it is incumbent on everyone to ensure drug quality,” Autor says.

Testing products only at the after they have been imported is not enough, Autor says. She urged companies to be aware of potential ways products can be contaminated. In addition, Autor encouraged diligence against product counterfeiting telling the audience to pay attention to how a product looks and to watch for sudden increases in price as a possible sign of counterfeiting.

While the FDA wants to increase its own presence overseas, it also works with regulators in other countries. The agency has reciprocal agreements with several foreign countries to share inspection results and conduct joint inspections. Autor says the FDA works with countries with less robust regulatory environments to get the country up to speed.

“We need people in other countries to be vigilant,” Autor says.

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