WASHINGTON — As China and India take larger roles in making the drugs found in American medicine cabinets, U.S. lawmakers asked the Government Accountability Office to investigate the Food and Drug Administration’s ability to oversee plants in other countries.

House Energy and Commerce Chairman Fred Upton, a Republican from Michigan, and Rep. Frank Pallone of New Jersey, the top Democrat on the committee, wrote to the government watchdog on Friday expressing concerns that “there is still inadequate oversight with regard to these foreign drug plants.”

The FDA has two drug inspectors in China to oversee about 700 facilities involved in drug manufacturing, Bloomberg News previously reported as part of a series of articles on a pattern among drug makers in China and India of deleting failed quality tests. The tests are meant to ensure that products are safe and include the ingredients and strengths they claim. The Asian drug makers would retest until they got the desired results and ship the product to the U.S.

The FDA will respond directly to the GAO about the request from Congress, agency spokesman Christopher Kelly said in an email. The FDA has hired three people for the drug inspections group in China that the agency plans to deploy, Kelly said.

Together, China and India manufacture more than 80 percent of the main ingredients in the world’s drugs, including in the U.S. and Europe, according to an Institute of Medicine report.

“We import more than $52 billion in human drugs every year and many of these products come from countries with less sophisticated regulatory systems than our own,” Upton and Pallone wrote. “The volume of imported drugs, the growing numbers of foreign entities producing these drugs, and the increasing complexity of the pharmaceutical supply chain have all significantly complicated FDA’s ability to provide sufficient oversight.”


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