- McKesson, the nation's largest drug distributor, found itself in the crosshairs of U.S. regulators earlier this year because of the way one of its facilities dealt with illegitimate products.
- To be considered illegitimate, there must be "credible evidence" the product in question is counterfeit, diverted or stolen; part of a fraudulent transaction; or intentionally adulterated in a way that could cause serious adverse effects or death, according to the Food and Drug Administration.
- In a Form 483 issued in July and disclosed by the agency this week, the FDA concluded McKesson did not have proper systems or protocols in place for addressing illegitimate products when they came through its facilities. For instance, regulators highlighted a policy where McKesson did not require its employees to notify within 24 hours any trading partner who the company thinks may have received such products.
McKesson marked an undesirable milestone in early 2017 when it agreed to pay $150 million to settle Department of Justice allegations that it violated the Controlled Substances Act by not reporting suspicious orders of painkillers like oxycodone.
The settlement came amid a deadly opioid crisis in the U.S. that has put a magnifying glass on each link of the pharmaceutical supply chain. While much of the focus has centered around manufacturers such as Purdue Pharma and Johnson & Johsnon, distributors haven't been able to hide.
Cardinal Health in late 2016 agreed to pay $44 million to settle its own case with the DOJ regarding violations of the Controlled Substances Act. A little more than a year later, AmerisourceBergen and McKesson found themselves defendants in a $500 million lawsuit from New York City aimed at companies the city claims contributed to its opioid overdose epidemic.
Disclosure of the Form 483 indicates McKesson is not yet on regulators' good side when it comes to flagging suspect orders and product.
The FDA inspected a McKesson facility in San Francisco at the end of June and beginning of July. Inspectors had three observations for the facility, all of which had to do with illegitimate product protocols.
Within one of its observations, the agency said that when notified of a product possibly being illegitimate, McKesson didn't check whether it was still at the site or shipped out yet. If the product was indeed on site, regulators said they found no evidence that it was properly quarantined — a requirement of the Food Drug and Cosmetic Act.
"Suspect product must be placed into quarantine and not processed further until suspicion is cleared or confirmed," the agency wrote. "There is no documentation demonstrating that your firm quarantined said products after receiving notification and during your investigation."
Regulators also determined the company didn't keep samples of suspected illegitimate products or help trading partners deal with these products when not in McKesson's possession.
"McKesson does not agree that we failed to follow procedures. Further, we have robust procedures in place for handling recalls," the company said in an emailed statement to BioPharma Dive.
"The company responded to the FDA in a timely fashion and is in the process of clarifying policies and implementing enhancements to address the FDA’s observations," McKesson added. "We take our role in helping to protect the safety and integrity of the pharmaceutical supply chain extremely seriously."