From: Reuters
Published May 1, 2008 03:40 PM

Lawmakers seek more foreign drug plant checks

By Lisa Richwine

WASHINGTON (Reuters) - U.S. lawmakers pledged on Thursday to raise more money for inspections of foreign drug plants after the deaths of dozens of patients treated with a blood-thinner made with imported ingredients from China.

One proposal would require drugmakers to pay fees to the U.S. Food and Drug Administration to boost capacity to check overseas manufacturing sites in an effort to keep counterfeit or contaminated drugs from reaching the U.S. market.

Batches of Baxter International Inc's recalled blood-thinner heparin were found to be tainted with a cheaper, heparin-like chemical that FDA officials say may have killed some patients and caused allergic reactions. Eighty-one deaths have been reported after treatment with some brand of heparin.


"What worries me is that without congressional intervention, this could happen again," said Rep. Frank Pallone, a New Jersey Democrat who chairs the health subcommittee of the U.S. House of Representatives Energy and Commerce Committee.

More than 80 percent of active drug ingredients are produced abroad, but the FDA has limited staff and funding to inspect overseas manufacturers.

The Democrat-controlled Congress is searching for ways to strengthen FDA oversight of imported food and drugs following a string of recalls of Chinese-made products in the past year, included tainted toothpaste and pet food.

Chinese officials have said the chemical in heparin, over-sulfated chondroitin sulfate, was not to blame for deadly reactions to the drug.

Republicans at the hearing backed the need for more inspections but some balked at having companies pay the cost rather than taxpayers.

"It seems to me this is an area where we should appropriate the money and not rely on fees," said Rep. Michael Burgess, a Texas Republican.

Representatives of drug and biotechnology companies said they wanted Congress to clarify the level of fees and exactly what they would be used for.

Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, agreed the agency needed congressional help to deal with an increasingly global drug supply.

"The world is changing and our ability to assure the quality of the drug supply is diminished," she said.

But she added that the FDA "cannot rely on inspection as its primary means of ensuring product safety." The proposed legislation "should be more closely targeted and prioritized according to risk," she said.

The measure would require FDA inspections of foreign drug plants every two years. It also would mandate that all foreign and domestic drug producers register annually with the FDA, and would provide some added enforcement powers.

Some requirements in the bill "would divert resources, which could detract from important drug safety and security priorities," Woodcock said.

On Tuesday, Woodcock told Congress it would cost about $225 million annually for the FDA to inspect, every other year, all pharmaceutical plants around the world that supply the U.S. market.

(Editing by Braden Reddall)

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