Companies that seek to manufacture products less expensively outside the U.S. might in some cases pay a price to come into regulatory compliance for the U.S. market, FDA Center for Drug Evaluation and Research Director Janet Woodcock cautions.

Addressing the Food and Drug Law Institute's Annual Conference April 22, Woodcock said that the less a non-U.S. country embraces a mature health product regulatory process, the more likely there are to be possible problems. Companies operating in those areas have to be prepared to work harder to ensure products made there meet U.S. regulations.

"What we're saying is we think firms have to make that trade-off," Woodcock said. "While the goods may be cheaper coming out, the due-diligence is going to have to be much more expensive."

While import safety has been in the Capitol Hill spotlight in the past few years, legislation such as Rep. John Dingell's, D-Mich., FDA Globalization Act has stalled.

But import safety and global regulatory improvements never seem far out of the minds of top FDA officials.

In a recent speech on FDA resources and regulatory science, Commissioner Margaret Hamburg said import safety remains a leading FDA inspection priority, especially in light of the growth in medical product shipments into the U.S. The agency has obtained a new computer shipment system to help prioritize inspections among other measures. Hamburg also said FDA needs to work with its regulatory counterparts in other countries to improve inspections, saying that "our role is a global responsibility" and that biopharma and medical device companies should participate in improving global safety oversight (Also see "Hamburg Seeks To Rebuild FDA After Years Of Insufficient Resources" - Medtech Insight, 15 February, 2010.).

Hamburg sometimes has characterized oversight of overseas drug manufacturing as "one of the greatest challenges" she faces as commissioner (Also see "Solution For Global GMP Oversight Elusive, FDA Commissioner Says" - Pink Sheet, 2 October, 2009.).

Hamburg elaborated on some of those themes in an earlier presentation at the FDLI meeting.

Foreign economic development a concomitant concern

FDA's efforts to assist other countries to improve their regulatory capacity not only serves U.S. interests, but also foreign economic development interests, she said. "We contribute to their economic growth and development by helping them to ensure an export market and to strengthen the industries within their countries and that is very important in a complex world."

Hamburg said she is working with philanthropic and other agencies to think about ways to provide such assistance. Both FDA and its foreign sister agencies share concerns about the demands of inspecting numerous facilities, "so working with other regulatory authorities that are quite mature and sophisticated to share information in new ways, possibly even share inspection responsibilities, I think is very important going forward.

FDA's Office of Regulatory Affairs already has established a number of foreign offices and expects to increase its foreign inspections this year, Michael Chappell, ORA acting associate commissioner for regulatory affairs and deputy associate commissioner for field operations, told the FDLI audience.

Those offices, in some cases, include ORA staff who can help with inspections. ORA also created specific pharmaceutical and medical device groups, or cadres, dedicated solely to foreign inspections. But Chappell said many foreign plant inspections still will be done by ORA field staff who also conduct domestic inspections.

Woodcock said FDA's compliance office would like to see more unannounced inspections at foreign factories. She warned that FDA still will not be able to be the best regulator for the entire world, despite its increased overseas presence.

"The world has to develop capable regulatory frameworks if we're going to take products from a sub-region or country," Woodcock said. "Because we are not able to go in there and ensure the quality from any given plant that's emanating from a certain region."

-Derrick Gingery (d.gingery@elsevier.com)

Foreign Manufacturing Cost-Savings Might Be Offset By Regulatory Due Diligence, FDA's Woodcock Cautions

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