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Panel grills officials on drug imports

Baltimore Sun

The government needs $225 million more in funding and a range of new powers to protect Americans from unsafe drug imports, federal health officials said Tuesday while facing tough questioning from a congressional committee investigating a contaminated blood thinner from China.

“We currently have a crisis and an opportunity to make real change,” Deborah M. Autor, director of the Food and Drug Administration’s drug compliance office, said at a House oversight subcommittee hearing.

Autor joined Dr. Janet Woodcock, director of the FDA’s drug division, in asking Congress to give the agency the power to inspect foreign companies that ship drugs to the United States, stop imports at the border if they come from factories not yet inspected, and require American drug makers to police their overseas suppliers.

Woodcock said the FDA would need $225 million in additional funding to inspect the 3,300 foreign drug-making plants as frequently as it reviews plants in the U.S. That is more than 20 times the agency’s current foreign drug inspection budget.

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The hearing began with relatives of victims describing in tearful detail how routine trips for dialysis led to trouble breathing, severe diarrhea and chest pain, then death.

Leroy Hubley of Toledo, Ohio, recalled how hospital doctors took his wife of 48 years, Bonnie, off life support last December while Christmas music played in the background. A few weeks later, his 47-year-old son, Randy, also died from the side effects of heparin.

Colleen Hubley, a dialysis nurse and Randy’s widow, described her desperate struggle to save his life.

“We were certain that no matter what came our way, we could handle it together,” she said. “Despite our hope, this man died while I did CPR on him, powerless to save him.”

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The contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions, said Rep. Bart Stupak (D-Mich.), chairman of the House Energy and Commerce subcommittee on oversight and investigations.

The FDA found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing, Stupak noted.

FDA officials have said the contaminant, an unapproved chemical modified to look like heparin’s main ingredient, was introduced somewhere in China. Agency officials have repeatedly said they can’t tell whether the contamination was deliberate, but Woodcock said at the hearing that it probably was.

After imports from China of pet food and toothpaste were found to be tainted, the Bush administration proposed basing inspectors overseas. The administration has refused to put a price tag on its plan; it emphasizes relying on American companies and foreign governments to assure the safety of products made abroad.

FDA officials have been reluctant in previous import safety hearings to stray from the administration’s standard message, even under hostile questioning from House Democrats who are drafting legislation that would expand the agency’s powers and make foreign firms shipping drugs to the U.S. pay user fees to cover the cost of inspections. The fees could bring in $300 million a year.

The tough questioning continued at the subcommittee hearing as Stupak and Rep. John D. Dingell (D-Mich.) interrupted FDA officials to determine the limits on the agency’s authority to prevent unsafe imports from entering the U.S. and learn what reform legislation should contain.

Unhappy with the answers he was getting, Dingell told FDA officials that they should be embarrassed by their testimony and emphasized that the agency needed to become a tougher watchdog. “You folks are more trusting than a kindergarten class,” he said.

Later, Woodcock and Autor provided the specifics about extra funding and authority. “Hallelujah,” Stupak said after the FDA officials detailed needs. “We’re making progress.”

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Heparin is widely used during kidney dialysis and open-heart surgery to prevent dangerous clots from forming. After scattered reports of serious side effects, Baxter International recalled most of its heparin products in February. Baxter had gotten a tainted ingredient from a plant in eastern China owned in part by Scientific Protein Laboratories, a Wisconsin company.

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The Associated Press contributed to this report.


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