Better foreign drug oversight is sought

Consensus emerges on need for more resources to monitor overseas suppliers

April 23, 2008|By Jonathan D. Rockoff | Jonathan D. Rockoff,Sun reporter

WASHINGTON -- Citing contamination of drugs, pet food and toothpaste from China, members of Congress have endorsed funding for more federal safety inspectors and to police overseas suppliers.

Dr. Andrew C. von Eschenbach, commissioner of the Food and Drug Administration, agreed that the agency needs more resources and for the first time accepted estimates, albeit tentatively, that an additional 500 inspectors and $70 million in funding was required to bolster foreign drug inspections.

The emerging consensus, voiced yesterday at a House subcommittee hearing, comes a day after the FDA said as many as 81 Americans died after taking a popular blood-thinning drug tainted somewhere in China with an unapproved chemical.

"Foreign inspections are unfortunately the neglected stepchild of the FDA's drug inspection program and that simply cannot continue," said Rep. Joe L. Barton, a Texas Republican.

Critics have pointed to a string of recalled Chinese products, including toothpaste containing a toxic diethylene glycol and pet food tainted with melamine. Contaminated heparin became the latest flash point after recalls began in February.

"If we don't make some rapid progress on fixing the foreign drug inspection program, the next `melamine' or `heparin' tragedy will soon be upon us," said Rep. Bart Stupak, a Michigan Democrat.

In the past 20 years, the FDA has lost more than $300 million in funding to inflation despite the responsibility of putting into effect 123 new laws, the agency's Science Board said.

The Senate recently passed a resolution giving the FDA an extra $375 million, a 20 percent boost, but it is unlikely the Bush administration will give the FDA a sizable increase. Members of Congress believe their best option is to lay the groundwork for more funding and hope the next president is more receptive.

Von Eschenbach acknowledged that the agency has not kept up with the rapid increase in drug imports. Each year, the FDA inspects 8 percent of the 3,000 foreign firms shipping drugs to the United States, the Government Accountability Office said in a new report.

Still, von Eschenbach emphasized that increased funding and staffing wasn't the entire solution, and he highlighted several agency initiatives to improve foreign drug inspections, such as relying on outside firms to certify facilities and targeting the riskiest imports for scrutiny. The FDA has also been talking to governments in China and India about placing U.S. inspectors there.

Rep. John D. Dingell said the initiatives weren't enough. Dingell raised his voice, pounded his desk and pointed at the commissioner to pressure him for an estimate on how much more funding the FDA needed for foreign inspections.

"You're carrying water for an administration that is not giving you the resources you need," said Dingell, a Michigan Democrat. Eventually, von Eschenbach agreed with staffing and funding estimates made by Republican staffers and the Government Accountability Office.

House Democrats are drafting a proposal that would give the agency more funding and authority to inspect and stop imports. Republicans voiced support for some of the ideas.

In November, the Bush administration issued its own import safety plan, which emphasizes working with foreign governments and U.S. manufacturers to assure the quality of supplies and production.

Health and Human Services Secretary Michael O. Leavitt said in an interview that his trips abroad to advance import safety showed the best approach to safeguarding imports wasn't necessarily more FDA requirements or inspections.

"To some, the answer is simply to inspect everything. I'm inclined to think they don't understand the breadth of this. There's just too much," he said.

jonathan.rockoff@baltsun.com

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