A year after two major drugmakers sued a wholesaler for its alleged role in distributing counterfeit HIV pills, the U.S. Food and Drug Administration warned the wholesaler for failing to ensure that “suspect” medicines did not enter the marketplace.
In a June 8 letter, the agency rebuked Safe Chain Solutions for violating a federal law designed to bolster the integrity of the pharmaceutical supply chain. Known as the Drug Chain Security Supply Act, the law was enacted a decade ago primarily to thwart counterfeiting, although it has been implemented in piecemeal fashion. It is supposed to go fully into effect this coming November.
The warning letter, which was posted Tuesday on the FDA website, was issued more than a year after Gilead Sciences and Johnson & Johnson filed separate lawsuits accusing Safe Chain — as well as several little-known distributors and pharmacies — of disseminating countless bottles of fake HIV medicines and incorrect pills, including antipsychotics.