Lawmakers Ask U.S. Watchdog to Investigate FDA's Asia OversightBy
FDA has two drug inspectors to oversee 700 plants in China
U.S. imports $52 billion in drugs a year from other countries
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 Representative 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 drugmakers 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 drugmakers would retest until they got the desired results and ship the product to the U.S.
There were cases where records mysteriously went missing while FDA inspectors were on site, or were moved into locked rooms out of inspectors’ reach, according to documents obtained through the Freedom of Information Act. In one instance at a plant in China, a factory worker pulled what looked like a memory stick from a computer and put it in the pocket of his lab coat when FDA inspectors walked into the room. When they asked to see what the man put in his pocket, he turned and ran.
The company said at the time that the man fled over a misunderstanding caused by a language barrier, and that he took an electronic key used for one of the lab machines, not a data storage device.
The FDA will respond directly to the GAO about the request from Congress, agency spokesman Christopher Kelly said in an e-mail. 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. The FDA also has acknowledged that China is increasingly interested in making finished drugs for the U.S. market as well.
“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.”
Representative Tim Murphy, a Pennsylvania Republican who serves as chairman of Energy and Commerce’s investigations subcommittee, and Representative Diana DeGette of Colorado, the top Democrat on the subcommittee, also signed the letter.
After criticism several years ago over the disparity between how often FDA inspected plants based in the U.S. and those in other countries, the agency opened offices in India and China. GAO has previously looked at FDA’s inspection numbers, beginning in 2008 through 2011, and while the agency increased inspections of plants in other countries, GAO still found that the agency needed to take steps to better assure the safety of drugs for the U.S. market.
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