FDA Scrutiny Scant In India, China as Drugs Pour Into U.S.

FDA Scrutiny Scant In India, China as Drugs Pour Into U.S.
Broad Overseas Checks Called Too Costly
By Marc Kaufman
Washington Post Staff Writer
Sunday, June 17, 2007; A01

India and China, countries where the Food and Drug Administration rarely conducts quality-control inspections, have become major suppliers of low-cost drugs and drug ingredients to American consumers. Analysts say their products are becoming pervasive in the generic and over-the-counter marketplace.

Over the past seven years, amid explosive growth in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries, and a few were the kind that U.S. firms face regularly to ensure that the drugs they make are of high quality. The agency, which is responsible for ensuring the safety of drugs for Americans wherever they are manufactured, made 1,222 of these quality-assurance inspections in the United States last year. In India, which has more plants making drugs and drug ingredients for American consumers than any other foreign nation, it conducted a handful.

Companies based in India were bit players in the American drug market 10 years ago, selling just eight generic drugs here. Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by American consumers are made by Indian manufacturers. Five years ago, Chinese drugmakers exported about $300 million worth of products to the United States. Eager to meet Americans' demand for lower-cost medicines, they, too, have expanded rapidly. Last year, they sold more than $675 million in pharmaceutical ingredients and products in the U.S. market...

The former head of the Chinese drug and food safety agency was recently sentenced to death for taking bribes from companies he regulated, and two major Indian companies received warning letters from the FDA in the past two years over serious infractions involving drug quality control. Private inspectors hired by U.S. companies to check out foreign plants report finding very good ones but also some without walls and that are open to dust and pests, chemical equipment crowded in ways that could lead to cross-contamination, and one plant that had a hornet's nest atop a drugmaking vat. One frequently cited case involves the intravenous antibiotic gentamicin, which was supplied by a company in China and linked to deaths in the United States in the late 1990s. Tests by German researchers found a wide range in quality and effectiveness in what were supposed to be uniform dosages of the drug, leading the scientists to write that "it was assumed" the deaths "were related to faulty manufacture." ...

http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html

Can this government be any less credible on the subject of the FDA and medications? I really doubt it.