Corporate responsibility, transparency to guide CDER enforcement efforts, FDLI told.(Compliance/Enforcement)

WASHINGTON, DC -- Improving corporate responsibility, not just boosting its overseas inspections presence, will be a key ingredient to Center for Drugs enforcement efforts, which for the remainder of 2009 will focus on unapproved drugs, supply chain and BioResearch Monitoring, in part.

That's the word from Center for Drugs Director Janet Woodcock, M.D., in addressing the 52nd annual Food & Drug Law Institute conference in Washington April 22-23.

Woodcock said agency senior managers are preparing for new challenges in drug regulation and trends. As manufacturing continues to move out of the U.S. and Europe and into emerging economies, some of the rising regulatory structures under FDA's watch are "very new," she said.

"We need to cover a lot of entry places in the U.S. For drug regulation, this is the real challenge," the director explained.

Many U.S. drugmakers are repositioning operations overseas. As they search for regions to manufacture their products most cost effectively, the shift has had a significant impact. "This trend is causing 'supply chain fragmentation,'" said Woodcock. "Different aspects of manufacturing and beyond are done all over the place--it introduces new risks to the whole supply chain."

The agency is responding to this disintegration by aggressively promoting corporate responsibility. "We've been telling everyone this has to be the cornerstone," said Woodcock. "It's fine to look at cost minimization, but firms have to ensure quality of product regardless of the source."

Newly established foreign sites with less experience and those that are loosely regulated will naturally require more oversight. FDA offices have already been established in India and China and are in progress for Latin America and the Middle East. The agency also hopes to increase inspectional capacity for foreign investigators and boost the number of GMP assessments performed.

"One of the best things about being overseas [is] we're in the same buildings, we're in the same offices [and] we're working much better," said Murray Lumpkin, M.D., FDA's Deputy Commissioner for International Programs in the Office of the Commissioner. "We can already see a difference."

This year, managing the manufacturing and supply chain has been a top priority for FDA. In addition to drafting guidance documents and developing pilot programs, such as the draft Food and Drug Administration Globalization Act of 2008 Secure Supply Chain Pilot Program, that give incentives to drug manufacturers to develop safe routes for importing products and devote resources where risks exists, the agency is crossing national borders to build bridges and initiate collaboration. Third-party inspection pilots and Food Emergency Response Network state partnerships are in the works.

Woodcock said unapproved drug circulation in the U.S. also will continue to occupy enforcement efforts. "We're still struggling with acetaminophen," she said. "We've seen hundreds of deaths related to toxicity." The Center is developing a number of unapproved drug initiatives to ensure pharmaceuticals in the U.S. are FDA approved. Dietary supplements, or those claiming to be, pose a huge threat to U.S. consumers.

There are other concerns for CDER as it moves toward the second half of 2009. The BiMo program has its shortcomings, said Woodcock, and institutional review boards are far from infallible. Organizational challenges regulating quality and basic research needs are not being met as well as they should be, partly because of funding. "The center has a lot of research needs, but we don't really have the funding to do it," said Woodcock. "Keeping current in the new science is a challenge, because that science is going to transform how drugs are developed."

By Carrie Nathans

Managing Editor

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