FDA Stretches to Go Global

This article published with permission from The Burrill Report.

Federal regulators struggling to catch up with global supply chains are working to strengthen ties to their foreign counterparts in China and beyond to better protect public health at home, the U.S. Food and Drug Administration says.

The agency is seeking $10 million from Congress to pay for additional staffing and drug manufacturer inspections in China and is developing new risk-based approaches to ensure product safety and quality to improve its results.

“The $10 million is a small drop in the bucket of what our overall needs are,” FDA Commissioner Margaret Hamburg testified recently before the Senate Appropriations subcommittee that oversees the FDA’s budget.

But coming to terms with globalization is “a huge priority,” she says. “FDA is at the cutting edge of much of this in terms of responding to the challenges of globalization. And at the present time we don’t have the tools and authorities that we fully need to achieve that nor do we have the resources.”

What the agency is doing with the limited resources it does have is covered in a new “Global Engagement Report” detailing its efforts and evolving responses to the growing complexities and dangers of imported food and drugs. More than 80% of the active pharmaceutical ingredients and 40% of finished drug dosages sold in the United States are manufactured abroad. The rise in imports from China has been particularly steep. From fiscal 2007 to 2011, the number of shipments of FDA-regulated products from China increased by 62%, according to FDA statistics. During that time, problems with contaminated baby formula and heparin produced in the China created international concern about the safety of products produced there.

"Today we recognize that to successfully protect U.S. public health, we must think, act, and engage globally,” says Hamburg. “Our interests must be broader than simply those within our own borders.”

The agency first set up foreign outposts after a series of contaminated imports from China triggered alarm over the safety of food and pharmaceutical products from there. The events made clear that the FDA’s lack of presence overseas impaired its ability to respond quickly and efficiently. It now has offices in China, India, Latin America, Europe, and as of June 2011, new offices in Jordan and South Africa. The FDA is using its staff in those locations to learn more about local regulatory systems and landscapes and to further strategies for better monitoring the safety of food and drugs product destined for importation to the United States, which it first outlined in its 2011 report, “Pathway to Global Product Safety and Quality.”

To overcome the constraints of its resources and authority abroad, the agency is seeking to get on the same page as other regulators to make the exchange of quality, safety, and efficacy information easier. It is also piloting programs to employ techniques such as data mining and pattern discovery techniques to evaluate and rank FDA-regulated imports based on their potential health risk.

Nevertheless, Hamburg acknowledges the challenges are significant.

“It still is a real problem,” she says, “to take enforcement action proactively in another country.”

Copyright 2012 Burrill & Company. For more life sciences news and information, visit http://www.burrillreport.com.