Bloomberg reports drug distributor McKesson Corp. allegedly sent pharmacies prescription opioids which had been replaced by over-the counter painkillers, according to the FDA. The agency said that inspections of the firm’s San Francisco headquarters “found the company had failed to respond adequately after being notified by regulators and drugstore customers about the tampered bottles” and “failed to keep proper records of its internal investigation of the matter.” McKesson spokeswoman Kristin Chasen said that McKesson “takes this situation very seriously. … We are committed to the security of the supply chain and are taking steps to help ensure we comply fully with FDA’s track-and-trace laws for all pharmaceutical products.”
CNBC quotes FDA Commissioner Scott Gottlieb, who said in a statement, “A distributor’s failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a violation of the law. But this is even more concerning given that we’re in the midst of a widespread opioid crisis.”
BioCentury reports that Gottlieb also indicated that the agency plans to develop new guidance on developing non-opioid analgesics. He also “said the agency is working with the U.S. Postal Service, Customs and Border Protection and Department of Justice to identify and prosecute shipping of illegal, unapproved or counterfeit opioids in international mail facilities.”
STAT, CQ Roll Call, and Axios also cover the story.
From the news release of the American Association for Justice.
