Jeff VanPelt

WASHINGTON, DC—U.S. lawmakers and federal officials are scrambling to tighten controls on imported bulk drugs after learning that an alarmingly large number of potentially dangerous counterfeits are making their way across U.S. borders.

“The FDA recently advised committee staff that as many as 242 firms worldwide appeared to have shipped misbranded drugs to the U.S. in 1999 and have never been inspected,” Rep. Fred Upton (R-MI) told members of a U.S. House Commerce sub-committee in October.

The extent of the problem was highlighted by earlier testimony in which it was announced that the FDA had known for four years of the deaths of several Americans caused by counterfeit drugs, and that the FDA and Centers for Disease Control determined that 89 Haitian children died from taking cough medicine made with antifreeze that had been labeled as glycerin.

Last month, several lawmakers accompanied FDA officials to China and India—two countries determined to be the source of a majority of the counterfeiting operations—to research the issue of counterfeit drugs. Through that investigation, staff members “obtained evidence that Chinese firms are secretly manufacturing drugs that are still under U.S. patent,” Upton says.

Upton says that the possible inclusion of China into the World Trade Organization could lead to increased counterfeits, but that “India may be the biggest counterfeiting problem because of the lack of patent laws and the lack of centralized regulatory control of the pharmaceutical industry.”