In the scary climate of the U.S. opioid crisis, it makes sense that the Food & Drug Administration would crack down on distributors who aren’t following the rules. And apparently the medical supply company McKesson has now been singled out for allegedly shipping “illegitimate” painkiller products. So far, the practices have merited a FDA warning letter, which outlined several issues.
The big callout in the letter was McKesson’s supposed failure to identify, quarantine and investigate drug shipments that have been tampered with. They specifically referenced three Rite Aid pharmacies in Michigan which received bad shipments. It is unclear which division of the company is taking the blame; but somewhere along the line, care was not taken with these particular products.
FDA Commissioner Scott Gottlieb did speak to the press about the incident, issuing the statement below.
“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. This is simply unacceptable.”
The Rite Aid incidents can be traced back to 2016, when McKesson shipped products that were allegedly misidentified. Apparently, bottles of oxycodone were filled with naproxen, leading one to wonder whether a swap was made somewhere along the route. McKesson did investigate the issues, but the FDA believes more could have been done.
In response to the letter, McKesson reps have already issued a statement of their own.
“We take this situation very seriously and have been in communication with the FDA over the past several months,” company reps explained. “We are now in the process of providing additional procedural detail and documentation, including enhancements recently made in response to the FDA’s initial feedback. 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.”
According to CNBC, the process can move rather swiftly after these types of letters are sent. Next steps can include legal action and a possible injunction. Per industry regulations, McKesson now has roughly 15 days to outline its clear correction process. And as you may expect, the company is facing private lawsuits as well, regarding opioids and the damage their products have done to various communities.