Flood of drugs, little oversight
- | TRIBUNE REPORTERS
- March 2, 2008
By the time St. Louis Children’s Hospital called in its infectious-disease specialist Jan. 4 to diagnose a mysterious spike in allergic reactions to kidney dialysis, it was clear there was a major problem.
Three patients had become ill after taking the blood-thinning drug heparin. One had developed the same reaction during a dialysis treatment in November. Minutes after dialysis needles punctured their veins, the boys’ lips and eyelids swelled. Their blood pressure dropped, and their heartbeats raced at dangerous levels.
Last week, a team of Food and Drug Administration inspectors visited the Chinese plant owned by Baxter supplier Scientific Protein Laboratories of Waunakee, Wis. There they found evidence of lax hygiene and safety standards.
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Indeed, a close look at the FDA’s resources and inspection record paints a picture of an agency struggling to keep pace. Although its officials insist the agency inspects every foreign plant sending medical products to the U.S., the agency’s own data make it appear unlikely.
An FDA-appointed commission that studied the agency’s inspection record last fall found the FDA is short of financial resources, has cut personnel, has rickety data management systems and is struggling to meet its oversight obligations.
“Millions of FDA-regulated products are imported into the country each year from foreign facilities that have never been inspected by FDA and, with current appropriations, never will be,” according to a report in November by the FDA Science Board’s subcommittee on science and technology.
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One surprise: Parkinson soon learned the FDA never had inspected the China manufacturing plant.
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By law and as a matter of policy, the Food and Drug Administration is the first line of defense for drugs entering the U.S. But critics say the agency’s financial resources and manpower have not kept up with the workload required to protect the public.
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Although drug imports have ballooned over the last five years, the amount spent on inspections fell slightly during that time.
While some 3,250 non-U.S. plants were subject to FDA inspection last year, the agency has conducted only 1,445 foreign inspections in the last five years, according to a recent Government Accountability Office study. That seems to leave the agency far short of a requirement that it inspect each plant every two years.
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The FDA has averaged just 15 inspections in China in each of the last five years. Yet China’s fast-growing industry now numbers 714 plants that ship drug products to the U.S.
At that rate, it would take the agency nearly 48 years to inspect each plant just once
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“The computer infrastructure is outdated, it’s not stable, there is insufficient security and capability,” said Dale Nordenberg, a Science Board member who specialized on the computer systems. “The FDA is still relying on an amalgamation of paper-based records and poorly integrated electronic platforms.”
The two main FDA databases cannot agree on how many foreign companies are subject to FDA inspection. One claims the number is 3,000, the other, 6,800.
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