FDA Issues Warning Letter to McKesson Corp.

FDA Commissioner Dr. Scott Gottlieb announced Feb. 12 that the agency has issued its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for what he described as "violations highlighted by a concerning tampering incident that involved opioid medications."

FDA Commissioner Dr. Scott Gottlieb announced Feb. 12 that the agency has issued its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for what he described as "violations highlighted by a concerning tampering incident that involved opioid medications." Gottlieb announced it in a statement about FDA's continuing efforts to prevent the distribution of illegal opioids and further secure the U.S. drug supply chain.

Those efforts include increased enforcement to interdict packages containing illegal products sent by mail. FDA has sent a series of warning letters in teh past year to online networks, operating at least 70 websites and illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, and the agency hosted Internet stakeholders and thought leaders, government entities, academic researchers, and advocacy groups at an Online Opioid Summit in June 2018 to discuss ways to collaboratively take stronger action to reduce the availability of illegal opioids online, he noted.

The warning letter is addressed to John H. Hammergren, chairman and CEO of McKesson, who is retiring effective March 31, 2019. Brian Tyler, the company's president and chief operating officer, will succeed Hammergren as CEO effective April 1.

The letter alleges that McKesson violated the act, which requires manufacturers, repackagers, wholesale distributors, and dispensers to have systems and processes in place to quarantine and investigate suspect and illegitimate medications. During an inspection from June 25 to July 3, 2018, at McKesson's headquarters, FDA inspectors found that the company failed to sufficiently respond to notifications that there were illegitimate products in their supply chain or to quarantine and investigate suspect products and maintain records of investigations of suspect product and disposition of illegitimate product as the law requires, the letter states.

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