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FDA commissioner warns drug companies of 'disruptive' regulations to fight opioid epidemic

  • The FDA could take actions on opioids that drugmakers may dislike, FDA Commissioner Scott Gottlieb says.
  • "We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," he says.

The Food and Drug Administration is likely to take new actions on opioids that may be "disruptive" and "uncomfortable" to drugmakers, the agency's commissioner said Thursday.

In addition to seeking to treat opioid-addicted patients with alternative medications that don't produce a high, the FDA says it will look at ways to reduce exposure to the drug. That includes new ways of packaging and distribution.

"For example, it's possible that a defined, short-term supply of medication could be packaged in a manner that limits the number of pills dispensed," the FDA said in a statement Monday.

When asked whether drug companies would fight the new packaging guidelines, FDA Commissioner Scott Gottlieb told CNBC on Thursday "potentially," because it could cost companies more money to package the drugs.

"We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," Gottlieb told "Squawk Box." "But we have to take more vigorous action to get ahead of this."

Opioid addiction in America has become an epidemic.
Lawrence K. Ho | Getty Images

Gottlieb said the agency is having discussions with drug companies about the new packaging solutions.

"Something like this could move potentially quickly," he said. "We're invested in taking a hard look at this and seeing what the opportunities are."

Opioids, including prescription painkillers and heroin, played a role in more than 33,000 U.S. deaths in 2015, according to the Centers for Disease Control and Prevention.

President Donald Trump last week declared the opioid crisis a national public health emergency. The move waives regulations and gives states greater flexibility in how they use federal funds to battle opioids.

The FDA is looking at expanding treatments to fight opioid addiction. There are currently three approved treatments, and "they all work," Gottlieb said.

"We're going to be putting out new guidance to manufacturers, to product developers trying to lay out new pathways, that they can develop alternatives to some of the treatments that are available," Gottlieb said.

— Reuters contributed to this report.

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