#3: The FDA Tackles Tainted Drugs From China

The realities of globalization hit the U.S. drug industry.

By Apoorva MandavilliDec 22, 2008 6:00 AM


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Following a series of high-profile scandals concerning tainted food and drugs imported from China, the U.S. Food and Drug Administration (FDA) announced in March that it would establish a drug-monitoring office in that country.

The most alarming report involved contaminated batches of the blood thinner heparin, which caused at least three deaths and is under suspicion in dozens of others. In February FDA officials admitted that they had never inspected Changzhou SPL, the manufacturing plant in Changzhou, China, to which they traced the contaminated heparin. When the FDA eventually inspected the Changzhou SPL plant (in February), it found a host of quality-control and hygiene problems.

Many drugs sold in the American marketplace are now imported, transforming what was once largely a domestic agency to one that must police products from more than 200 countries, notes Murray M. Lumpkin, FDA deputy commissioner for international and special programs. “The reality of globalization has hit the products for which we’re responsible very, very significantly,” he says. The pharmaceutical production process is also vastly more complex than it used to be. Individual ingredients are made in one place, put together in another, and bottled and labeled in still other sites.

According to the Government Accountability Office (GAO), the FDA annually inspects about 7 percent of foreign plants that manufacture drugs imported by the United States. In China, which has the most manufacturing plants, the FDA inspected the smallest proportion: 80 out of an estimated 714 plants between fiscal years 2002 and 2007.

Establishing a permanent presence in China is the first step in a larger plan that will place FDA offices in India, Latin America, Europe, and the Middle East, Lumpkin says. The FDA has the right to block the importation of unsafe products, but it cannot compel foreign governments to allow inspections on their soil. Often the FDA must announce the arrival of their officials in advance of inspections.

In 2009 the FDA plans to spend about $13 million on foreign inspections, but the GAO estimates that the agency would need $16 million to inspect all the plants in China alone. On April 29, at a hearing of the House Subcommittee on Oversight and Investigations, Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said the agency would require another $225 million a year to be able to inspect all foreign manufacturing plants every two years.

The FDA is also aiming for more cooperative relationships with its counterpart agencies in China and elsewhere, collaboration with the World Health Organization to develop technologies that can identify contaminated products, and an up-to-date database of foreign plants. Also needed, says Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, is an elaborate system that monitors drugs at various points in the supply chain.

“Absent a really good tracking system for both food and drug products, I don’t know that having people abroad is going to solve the problem,” Goozner says. “One could be generous, I suppose, and say it’s a start.”

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