FDA Stretches to Go Global, from The Burrill Report

The Burrill Report

With limited resources, agency targets trouble spots and seeks cooperation.

“The $10 million is a small drop in the bucket of what our overall needs are.”

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” [http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm298576.htm] detailing its efforts and evolving responses to the growing complexities and dangers of imported food and drugs. More than 80 percent of the active pharmaceutical ingredients and 40 percent of finished drug dosages sold in the United States are manufactured abroad.
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