輸入薬剤の安全性確保には予算と権限が必要/米国FDA

画像 中国からの汚染されたヘパリン製剤を調査している議会の委員会からの難しい質問に対し、危険な薬から米国人を保護するには2億2500万ドルの予算増と新たな権限が必要とFDA薬剤部門役員は答えた。海外の製薬企業の査察や取り締まりの権限付与が必要で、3,300の海外プラントの検査には現在の20倍の2億2500万ドルの追加費用が必要となる。公聴会は、定期の透析中に呼吸困難、重症下痢、胸痛、その後死亡した被害者親族の証言で始まった。被害は死者81人、重症アレルギー反応785人に上る。
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FDA calls for more money and power to keep imported drugs safe
http://www.latimes.com/features/health/la-na-heparin30apr30,0,4182979.story
A congressional panel grills officials and hears from relatives of those who died after using tainted heparin.
By Jonathan D. Rockoff, Baltimore Sun
April 30, 2008
WASHINGTON -- 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.

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."

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."

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.

The Associated Press contributed to this report.

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FDA's Mission Statement
http://www.fda.gov/opacom/morechoices/mission.html
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

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