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FDA commissioner outlines new opioid enforcement action

The agency used, for the first time, a new type of enforcement designed to control the illegal flow of opioids

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md. (Al Drago/CQ Roll Call file photo)
The outside of the Food and Drug Administration headquarters is seen in White Oak, Md. (Al Drago/CQ Roll Call file photo)

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.”

Broader strategy

The effort is part of a three-pronged strategy at the FDA that Gottlieb has spearheaded in helping to control the flow of illegal opioids.

Gottlieb said the FDA has already made an impact on drugs coming through international mail facilities, or IMFs, after working with Congress to get additional resources and authorities.

“We often catch substances coming through the IMF disguised as legitimate drugs,” said Gottlieb, adding that the FDA relies on U.S. Customs and Border Control and the Drug Enforcement Administration officials to flag suspicious deliveries.

The commissioner also emphasized another part of the FDA’s approach, which is increased efforts to conduct oversight of websites selling counterfeit opioids.

In the future, Gottlieb said the agency may use other expanded authorities in last year’s opioid law to combat the opioid epidemic.

“There are some authorities in the recently passed opioid legislation that relate to the requirements for blister packaging,” said Gottlieb, adding that FDA hasn’t determined yet how the agency is going to use those new authorities but it will be an area of focus.

FDA also announced that it plans to issue new guidance this year for product developers creating both new opioid analgesics and non-opioid analgesic alternatives.

The current guidance recommends that a pain medication be tested in a broad range of conditions to determine if it is effective in alleviating pain. The new guidance will encourage more focused drug development, meaning that specific areas of pain could be tested in a more targeted way.

“We think that’s going to provide for a more efficient development pathway and a more efficient way to market for specific non-opioid alternatives,” said Gottlieb.

Congress continues to monitor the national opioid problem. The Senate Health, Education, Labor and Pensions Committee held a separate hearing Tuesday morning that focused on pain management.

The hearing focused on ways to improve patient care while examining new ways to treat patient pain.

“We are engaged in a massive effort to make dramatic reductions in the supply and use of opioids — the most effective painkiller we have. But on the theory that every action has an unintended consequence, we want to make sure that as we deal with the opioid crisis, we keep in mind those people who are in pain,” said Committee Chairman Lamar Alexander, R-Tenn.

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