Last month, a top drug safety official told lawmakers that the US Food and Drug Administration (FDA) needs more to better track products entering the US from the burgeoning group of overseas drug manufacturers, brokers, and distributors currently doing business here. The FDA focuses on domestic companies, with about 1,200 inspections conducted annually in the US; however, only about 300 foreign facilities are inspected annually and, of these, about 10 percent of the firms shipping pharmaceuticals here, said Dr. Janet Woodcock, acting director of the FDA’s Center for Drug Evaluation and Research.
Now, in an important, new development, the FDA received approval from the US State Department to establish eight full-time, permanent positions at US diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government. This is one step in the FDA’s plans to hire and place staff in China over the next 18 months. The FDA will also be hiring a total of five local Chinese nationals to work with the new FDA staff at the US Embassy in Beijing and the US Consulates General in Shanghai and Guangzhou.
“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters,” said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. “Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market.”
According to the FDA, this move supports its “Beyond our Borders” initiative by working to strengthen relationships with counterpart agencies globally and enhance technical cooperation with foreign regulators. The permanent overseas offices in China are being created in the hopes of allowing increased access for inspections and greater interactions with manufacturers to help ensure products shipped to the US meet US standards for safety and manufacturing quality.
Foreign inspections were especially relevant following ongoing and heightened concerns about the blood thinner heparin which has been linked to 21 deaths and adverse reactions in over 700 patients. Millions take heparin annually to avoid potentially life-threatening blood clots.
Representative Rosa DeLauro, Democrat-Connecticut, chairman of an appropriations panel responsible for FDA funding, said the agency had not inspected a Chinese factory that may be a source of problems with heparin, which is manufactured by Baxter Healthcare Corp. She called the case embarrassing, but that it helped demonstrate the FDA’s “myriad failures under the Bush administration.” Meanwhile, there’s mounting evidence supporting reports that small, homemade Chinese factories develop and supply crude heparin under filthy and unregulated conditions. In November, the Government Accountability Office found the FDA didn’t know how many foreign firms are actually subject to inspection. The agency has a list of 3,249 firms, but at the current rate of inspection, it would take the FDA over 13 years to go through each firm on its list. The agency also could not confirm how many foreign firms have never been inspected.
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