FDA Issues Warning To Drug Manufacturer Over Product Tampering

FDA Issues Warning To Drug Manufacturer Over Product Tampering

By Kelly Burch 02/15/19

McKesson is the first drug manufacturer to get a warning letter from the FDA about properly securing and tracking drug shipments.

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drug manufacturer CEO reading warning letter from FDA

In 2016, three Rite Aid pharmacies reportedly unloaded what were supposed to be bottles of opioid pills, only to discover that the pills had been replaced with other medications such as Aleve.

Now, partly because of those incidents, the Food and Drug Administration has issued a formal warning to the drug manufacturer McKesson for shipping "illegitimate" opioids and not properly tracking drug shipments. 

"This is simply unacceptable," FDA Commissioner Scott Gottlieb said in a statement

Gottlieb said that the FDA has taken measures to curb the flow of illegal drugs into the country. However, the administration also relies on the cooperation of drug manufacturers to ensure the safety of prescription drugs. 

“Just as critical are the FDA’s efforts to protect patients from exposure to drugs that get into the legitimate U.S. supply chain that may be counterfeit, stolen, contaminated or otherwise harmful, as well as making sure these same drugs aren’t being diverted for illegal sale,” Gottlieb wrote. “Entities within the supply chain must also comply with the law and do their part to respond quickly and thoroughly when notified of potential counterfeit, stolen or diverted products entering the supply chain.”

Gottlieb said that the warning letter to McKesson is the first issued under the Drug Supply Chain Security Act

“The warning letter to McKesson outlines violations observed during inspections that took place this past summer, including failing to: sufficiently respond to notifications that there was illegitimate product in their supply chain; quarantine and investigate suspect products; and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires,” he wrote. 

When one pharmacy received medications that had been tampered with, it alerted McKesson to the issue. The distributor launched an investigation, but the FDA said it was not thorough enough. 

“While McKesson’s internal investigation noted that it was likely the opioid medication was replaced while in their possession or control, McKesson did not sufficiently respond to the notification that they may have distributed illegitimate products,” Gottlieb said. 

According to CNBC News, McKesson is taking the warning "very seriously.” 

The company said in a statement, "We have been in communication with the FDA over the past several months to respond to their questions and we are 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."

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Kelly Burch writes about addiction and mental health issues, particularly as they affect families. Follow her on TwitterFacebook, and LinkedIn.

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