Drugs

FDA Warns McKesson on Opioid Tampering

David McFarland

— 2 min read
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FDA commissioner Scott Gottlieb says the agency has issued its first Warning Letter under the Drug Supply Chain Security Act, citing McKesson Corp. for violations highlighted by a “concerning tampering incident that involved opioid medications. Other incidents involved medications for serious medical conditions including HIV, seizures, bipolar disorder, and high blood pressure.”

The 2/7 letter reports findings from a 6/26-6/29/18 agency inspection at the firm’s Wilsonville, OR, distribution center. It summarizes significant violations of the verification requirements that FDA says are “intended to help preserve the security of the supply chain for prescription drug products, thereby protecting patients from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.” Specific violations noted were: 

  •          failing to respond to illegitimate product notifications as required, including identifying all illegitimate product subject to such notifications in the company’s possession or control and quarantining such product;
  •          failing to quarantine and investigate suspect product; and
  •          failing to keep, for not less than six years, records of the investigation of suspect product and the disposition of illegitimate product.

FDA says McKesson’s responses to the inspection observations could not be evaluated because they lacked sufficient supporting documentation. The company was told to respond with a list of specific steps taken to (1) correct the violations identified in the Warning Letter and (2) identify and conduct appropriate investigations and follow-up related to other reports of suspect or illegitimate product that McKesson has identified or received. The company was told to explain each step taken and include copies of related documentation, It also was told to provide steps it has taken to prevent incidents of theft and diversion.

In a statement announcing the Warning Letter, Gottlieb says McKesson’s actions are “simply unacceptable. 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. Opioids that leave the legitimate supply chain could end up being sold illegally, or a patient who was appropriately prescribed these drugs to treat pain may not get the treatment they need or may unknowingly take a medication that’s not meant for them. This may put the patient at risk of side effects or adverse drug interactions.”

Gottlieb reviews other actions the agency has taken to help combat the opioid crisis and says it plans to publish in 2019 a guidance describing application of the risk/benefit framework to opioid analgesics, taking into consideration the full range of risks associated with these products, including the risks created by illicit use. And FDA is developing new guidance to modernize the development pathway for non-opioid analgesics to treat acute and chronic pain.

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