Drug distributor McKesson, which has already paid $150 million in federal penalties for lax controls over opioids in its supply chain, has now been personally lambasted by FDA Commissioner Scott Gottlieb, M.D., for newly discovered failings.
Gottlieb’s lashing cited a warning letter posted on Tuesday by the FDA saying McKesson did not sufficiently investigate reports of tampering in which bottles that were supposed to contain opioids instead contained over-the-counter naproxen.
When notified of the problem by pharmacy chain Rite Aid, Gottlieb said McKesson did not make an effort to identify or “quarantine additional illegitimate products that may have still been in their distribution facilities” or alert other pharmacies that they may have received bottles that did not contain the prescribed painkillers.
“This is simply unacceptable,” Gottlieb’s statement said. “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.”
In an emailed statement Wednesday, McKesson said it "takes this situation very seriously," and has been in contact with the FDA for several months over its concerns.
"We are in the process of providing additional procedural detail and documentation, including enhancements recently made in response to the FDA’s initial feedback," the company said. "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."
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This is not McKesson's first time in this situation. It paid a record $150 million fine in 2017 for a repeat offense of not reporting suspicious orders for opioid drugs. Cardinal Health and AmerisourceBergen settled smaller lawsuits. All three have been named in other lawsuits alleging they contributed to the nation’s opioid crisis.
Last year, McKesson announced its support for fighting the drug addiction problem and laid out the steps it has taken, including beefing up efforts to keep addictive drugs from being diverted out of the secure supply chain. But according to the warning letter, some of those efforts have failed. It showed the tampering was the result of an internal problem that arose in 2016. The FDA uncovered the problems during inspections last summer of McKesson’s San Francisco headquarters and a distribution facility in Wilsonville, Oregon.
In addition to diversions of opioids, the warning letter lays out similar issues with HIV, seizure, bipolar disorder and high blood pressure drugs. The FDA said the company did not have the required records in some cases to track down all of the potentially affected drugs and did not carefully investigate drugs with the same lot numbers so any “illegitimate product in their supply chain” could be removed.
The warning letter is the first to be filed under the Drug Supply Chain Security Act, which was passed in 2013 and requires everyone in the secure supply chain, from drugmakers to distributors to pharmacies, to have systems to track and trace products by identifiable numbers.