FDA commissioner outlines new opioid enforcement action
WASHINGTON — The Food and Drug Administration released a warning letter to a top drug distributor on Tuesday, using for the first time a new type of enforcement authority that the agency’s head called an important step in controlling the illegal flow of opioids.
FDA’s letter alleged that distributor McKesson Corp. sent drugs that were supposed to be opioids — but were missing pills or were not even opioids — to multiple pharmacy locations, raising questions about whether potent opioid painkillers were missing and where they may have gone.
In an interview with CQ, FDA Commissioner Scott Gottlieb said the agency was using authorities granted under the Drug Supply Chain Security Act for the first time to send the warning letter.
“This is the first action in a new policy effort by the agency in what might be a series of actions,” Gottlieb told CQ. “I don’t want to allude to any other enforcement actions we may have, but we may very well take additional actions with respect to the legitimate supply chain and risks that we see for diversion going out of the supply chain.”
He added that the agency is going to be looking harder at distribution.
“Given what we’ve learned both generally and in the context of this case, we’re going to be looking much more closely at the legitimate supply chain and the opportunity and the risks of diversion,” said Gottlieb.
The potential harm for patients is clear when drug distributors ship the wrong amount or type of drugs, Gottlieb said in a separate 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,” he wrote. “This may put the patient at risk of side effects or adverse drug interactions.”
The effort is part of a threepronged strategy at the FDA that Gottlieb has spearheaded in helping to control the flow of illegal opioids.