By Mary Agnes Carey, CQ HealthBeat Associate Editor

A top Food and Drug Administration (FDA) official told a Senate panel Thursday that the increasingly large number of pharmaceutical ingredients manufactured abroad makes it nearly impossible for the agency to ensure the safety of all drugs sold in the United States.

“We cannot be the quality-control unit for the world,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, told the Senate Education, Labor, Health and Pensions Committee.

While the FDA welcomes additional resources to improve its inspection of foreign manufacturing facilities, additional improvements — such as a better information technology system and a registry of all manufacturers producing products imported into the United States — are necessary to help improve efforts to stop contaminated drugs from entering the country, Woodcock said. She also told the panel that manufacturers must assume greater responsibility for the quality of their products.

Scrutiny of FDA’s ability to inspect foreign drug-manufacturing plants has increased on Capitol Hill after the blood-thinning drug heparin, produced in China, was found to be contaminated and may have been a factor in up to 81 deaths. New data released April 22 by the Government Accountability Office found that the FDA’s fiscal 2009 budget of $13 million for foreign inspections is inadequate — since the agency would need between $67 million and $71 million annually to biennial inspections of each of the 3,249 foreign drug manufacturers currently listed with the FDA. (See related story, CQ HealthBeat, April 22, 2008)

Senate HELP Chairman Edward M. Kennedy , D-Mass., said the FDA needs more resources to monitor products produced overseas, but manufacturers also must use better tests to detect impurities and contaminants in their products. “Even the most up-to-date manufacturing processes won’t ensure safety if manufacturers can’t guarantee the ingredients aren’t contaminated,” he said.

The panel’s ranking Republican, Mike B. Enzi of Wyoming, said putting more money into inspections would not guarantee safe imports. “The reality of the global economy is that testing every food and drug product from outside the [United States] is not currently possible, nor will it every be,” he said. Enzi and other speakers made the point that additional FDA inspections would not have caught the tainted heparin because the contamination occurred before the product reached the manufacturing facility, and that more sophisticated tests were needed to detect the contaminant.

House Energy and Commerce Chairman John D. Dingell , D-Mich., has proposed draft legislation that would assess user fees for all domestic and foreign drug and food producers, with the funds directed toward a new FDA inspections and safety corps.

Enzi said the agency should be allowed to first absorb new authorities Congress gave it last year in an overhaul measure (PL 110-85) before Congress adds any new responsibilities. “Rather than jump to quickly amend those new provisions, we should give FDA the time to fully utilize those new authorities and evaluate their effectiveness,” he said. (See related story, CQ HealthBeat, April 23, 2008)

In her remarks, Woodcock noted that over the last 15 years, much of the pharmaceutical manufacturing process has moved overseas, with drugs then imported back to the United States for sale. Elements of generic drugs may be manufactured in 15 different facilities, she said, “The FDA of the last century is not constructed” to regulate that kind of marketplace, Woodcock said. “Inspection resources have dropped while responsibilities have soared.”

After her testimony, Woodcock reiterated that much of the responsibility for quality products rests with drug makers themselves. “We’re holding them accountable for their quality system, not being their quality system,” she told reporters. “Any legislative fixes that do not address quality by design will fail.”