The Food and Drug Administration began its crackdown on the opioid epidemic Tuesday with a warning letter sent to drug distributor McKessson for allegedly shipping “illegitimate” product, taking the agency’s first formal enforcement action to curb abuse.
Specifically, the FDA is accusing McKesson of failing to identify, quarantine and investigate drug shipments that had been tampered with. Some of the illegitimate products were discovered at a Rite Aid pharmacy in Milford, Michigan.
“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,” FDA Commissioner Scott Gottlieb said in a statement. “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.”
In its warning letter, the FDA cited three examples where McKesson shipped prescription drugs that were supposed to be opioids and pharmacies discovered the opioid pills were removed and replaced with other products.
“This is simply unacceptable,” Gottlieb said.
This story is developing. Check back for updates.