FDA: More Foreign Inspectors Needed
AP , Washington: Feb 27 2008
Made Popular Feb 27 2008
United States :

The Food and Drug Administration needs more inspectors and a comprehensive computer database to better track products entering the United States from a growing number of drug manufacturers, brokers and distributors, a top drug safety official told lawmakers Wednesday.

The FDA focuses its inspections on domestic companies, with about 1,200 inspections conducted annually in the United States. Meanwhile, only about 300 foreign facilities are inspected each year. The latter number amounts to only about 10 percent of the firms shipping prescription drugs or their ingredients into the U.S., said Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research.

The small number of foreign inspections seemed particularly relevant Wednesday as a result of concerns about the blood thinner Heparin. Two weeks ago, the drug was linked to four deaths and adverse reactions in about 350 patients. Millions of patients take the drug every year to avoid potentially life-threatening blood clots.

Rep. Rosa DeLauro, D-Conn., chairman of an appropriations panel responsible for funding the FDA, said the agency had not inspected a Chinese factory that may be a source of problems with Heparin, which is manufactured by Baxter Healthcare Corp. She noted that the FDA intended to inspect the manufacturer of an ingredient in the drug, but apparently inspected the wrong factory, and the wrong firm was entered into the FDA’s database. She called the case embarrassing, but more than that, it helped demonstrate the FDA’s “myriad failures under the Bush administration.” She described the agency’s work as motivated by ideology and hampered by incompetence.

Woodcock appeared before DeLauro’s subcommittee. Lawmakers continually asked Woodcock what additional resources she needed. She was often hesitant to provide specifics, but if she could get more resources, the top two priorities would be to hire more investigators and upgrade the agency’s computer systems, she said.

FDA officials said the president’s 2009 budget recommended enough funding for an additional 31 full-time employees, on top of the 232 investigators now in the field, but they also acknowledged that substantially all of the money would come from higher user fees that have not yet been approved.

Lawmakers asked Woodcock to level with them about exactly how many more investigators should be hired, so they could potentially provide the money needed. But she said that number depends upon a variety of factors, including how often it’s determined that foreign firms should be inspected.

“You’re putting me in an awkward position,” Woodcock said at one point.

“It’s very painful not to get these answers,” said Rep. Sam Farr, D-Calif.

In November, the Government Accountability Office found the FDA doesn’t know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms that it uses to prioritize which ones should be inspected. But at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also cannot say how many foreign firms have never been inspected.

DeLauro noted that funding for foreign inspections has fallen nearly 30 percent under the Bush administration even though the number of firms to be inspected has increased. She called the agency negligent. But Woodcock said the FDA was still the gold standard that other countries tried to model. She said a series of well-publicized drug-safety problems over the years can be partly attributed to the agency getting much better at finding problems.

Rep. Jack Kingston, R-Ga., said he disagreed with DeLauro’s description of the agency. He said it was his impression that the FDA has struck the proper balance between safety and getting drugs to the market that can help patients.

“I don’t think there is a safety crisis in America,” Kingston said.

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On the Net:

Food and Drug Administration: http://www.fda.gov

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