While the FDA has made forward progress regarding the inspection of drugs manufactured overseas, the issue of deadly drug contamination caused by foreign producers continues to be a growing problem. Currently, the FDA is not able to fully guarantee the safety of drug products made overseas, nor are they able to adequately monitor the safety of the foreign-based pharmaceutical ingredients being used to make them. In fact, back in 2008, pharmaceutical company, Baxter International, endured a contamination crisis after several hundred patients became severely ill as a result of using the company’s popular blood thinner, Heparin, which had been manufactured in China.
Last week, representatives from the FDA addressed members of a U.S. Senate Committee last week, saying that the onset of another crisis is “not a matter of if, it’s a matter of when.” The agency went on to tell the Government Accountability Office that U.S. law currently limits its regulatory power to police overseas drug production. To that end, the FDA requested that Congress give them the power to compel drugmakers to recall any risky medications and initiate a track-and-trace system that would follow drugs from the manufacturers directly to retail shelves. At present, approximately 40 percent of medications used in the U.S. are manufactured by foreign producers, and 80 percent of the active ingredients in these pharmaceuticals come from outside of America’s national borders.
Protecting the security of the nation’s drug supply is a “top priority,” said Karl Uhlendorf, the Vice President at the Pharmaceutical Research and Manufacturers of America.