US Lawmakers: FDA fails on foreign drug oversight

Lax U.S. oversight of drug ingredient makers in China and other countries is putting Americans at risk of exposure to more dangerous medicines like the tainted blood-thinner heparin, lawmakers said on Tuesday.

While more than 80 percent of active drug ingredients are produced abroad, the U.S. Food and Drug Administration inspects few foreign plants and does not have adequate plans to increase them, said members of a U.S. House of Representatives panel.

“I believe FDA is not up to the task, as it cannot or will not undertake the reforms needed to protect Americans from this threat from abroad,” said House Energy and Commerce Committee Chairman John Dingell, a Michigan Democrat.

The scrutiny of the FDA’s foreign drug oversight intensified after Baxter International Inc recalled most of its heparin products in February because of a spike in reports of sometimes-fatal allergic reactions.

On Monday, FDA officials said new evidence linked a contaminant in heparin made in China to the reactions. Chinese officials said the chemical, an altered form of chondroitin sulfate, was not to blame.

Eighty-one deaths following allergic reactions have been reported to the FDA in patients treated with some brand of heparin since January 2007. The FDA did not inspect Baxter’s Chinese supplier before approving its version.

At the hearing, lawmakers said they feared other patients could be harmed as the FDA inspects foreign drug plants at the rate of only once every 13 years.

Rep. Bart Stupak, chairman of the panel’s oversight subcommittee, also pointed out that pet food from China was contaminated last year with the chemical melamine and killed scores of U.S. dogs and cats.

“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 Stupak, a Michigan Democrat.

FDA Commissioner Andrew von Eschenbach said increasing globalization of manufacturing and a growing market “has placed tremendous strains on our import safety system” and that he had “consistently endorsed the fact that this will require additional resources.”

The Government Accountability Office, an investigative arm of Congress, estimated it would cost between $67 million and $71 million to inspect the 3,200-plus foreign drug plants registered with the FDA every two years. The FDA has proposed spending about $11 million on foreign inspections in fiscal 2008, the GAO said.

Dingell said the FDA had failed to ask Congress for sufficient funding to protect the public from unsafe drugs.

“You presided over this (heparin contamination) because you do not have the resources to do the job you need ... You are presiding over an intolerable situation,” Dingell told Von Eschenbach.

Simply increasing inspections would be insufficient, Von Eschenbach said. The FDA is implementing a broad plan that included opening an office in China, upgrading computer systems and working with authorities in other countries, he said.

“In addition to addressing the need to increase our inspections, we also need to overhaul the entire system,” von Eschenbach said.

Republicans on the committee agreed the FDA needed to improve its record of checking overseas plants.

“Foreign inspections are unfortunately the neglected stepchild of the FDA’s drug inspection program and that simply cannot continue,” said Rep. Joe Barton of Texas, the committee’s leading Republican.