Washington Report

FDA, Congress Push for Safer Drugs (continued)

Catching counterfeiters FDA's efforts to enhance its drug safety information system also tie in with its continuing campaign to identify and prosecute drug counterfeiters. The agency recently warned consumers to watch out for counterfeit versions of some widely used drugs in Mexican pharmacies. FDA has revised its MedWatch reporting system to make it easier for health professionals to report bogus products to AERS, namely by adding "suspect counterfeit" to the list of product problems that might be reported on MedWatch. FDA also has established a Counterfeit Alert Network (CAN) that coordinates with health professional and consumer groups to alert members of counterfeit "events." A May 2005 update about FDA initiatives for combating counterfeit drugs reports that the agency initiated more criminal investigations against counterfeiters in 2004. FDA continues to back the use of electronic track-and-trace technology to verify the identity of genuine pharmaceuticals. Pharmaceutical Research and Manufacturers of America (PhRMA) is working with FDA on a plan to implement a broader radio frequency identification tracking system, but believes that this will take much longer than FDA anticipates (at least five years). Congress is looking to provide a boost for such initiatives. The Senate health committee approved a bill in May that provides grants for states to establish standards for collecting drug distribution data. The bill specifically aims to improve the monitoring of controlled drug substances, but such efforts would expand databases on safety issues for prescription drugs overall. Wholesale changes Another tactic for curbing counterfeiters involves scrutinizing and limiting the role of drug repackagers and secondary wholesalers in the drug distribution system. Although most of these firms provide legitimate services in supplying retailers and wholesalers with specialty products and items in short supply, this segment of the drug supply chain has been identified as an avenue for fraudulent operators to move bogus and adulterated drugs into the US distribution system. While policymakers weigh options for addressing this problem, pharmacies and wholesalers are taking action. In May, the CVS pharmacy chain announced that it no longer will purchase drugs from wholesalers that trade in the secondary market. CVS plans to do business either directly with manufacturers or with wholesalers that certify that they do not generate products from repackagers or secondary wholesalers. Similarly, wholesaler Cardinal Health announced that it will purchase drugs only direct from manufacturers or from established distributors and that it is closing a division that trades in the secondary market. Observers speculate that this action may be a response to ongoing investigations into interwholesaler purchasing. The broader effect of such changes on drug supplies and shortages remains to be seen. PT