### FDA Warns Wholesaler for Distributing Counterfeit HIV Pills
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 (FDA) has issued a warning to the wholesaler for failing to ensure the integrity of the pharmaceutical supply chain. The FDA’s warning letter, posted on their website, accuses Safe Chain Solutions of violating the Drug Chain Security Supply Act, a federal law designed to prevent counterfeiting in the pharmaceutical industry.
#### Background
– Safe Chain Solutions is accused of distributing fake HIV medicines and incorrect pills, including antipsychotics.
– The FDA’s warning comes more than a year after Gilead Sciences and Johnson & Johnson filed separate lawsuits against Safe Chain and other distributors and pharmacies.
– The Drug Chain Security Supply Act is set to go fully into effect in November.
#### FDA Warning Letter
The FDA’s warning letter to Safe Chain Solutions highlights the wholesaler’s failure to prevent “suspect” medicines from entering the marketplace. The agency’s rebuke is in line with the efforts to strengthen the integrity of the pharmaceutical supply chain and combat the distribution of counterfeit drugs.
#### Impact on the Pharmaceutical Industry
– The FDA’s warning serves as a reminder to wholesalers and distributors to prioritize the safety and authenticity of medications.
– Drugmakers are increasingly taking legal action against entities involved in the distribution of counterfeit drugs to protect their brand reputation and ensure patient safety.
– The implementation of the Drug Chain Security Supply Act in November will further enhance the measures against counterfeiting in the pharmaceutical supply chain.
For more information, read the [FDA warning letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safe-chain-solutions-llc-636044-06082023) and the [lawsuits filed by Gilead Sciences and Johnson & Johnson](https://www.statnews.com/pharmalot/2022/05/31/gilead-johnson-counterfeit-supply-chain/).
