Smaller Opioid Pill Packs Top FDA Priority in Opioids Bill

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By Jeannie Baumann

Blister packs to limit the supply of opioids per patient will be the first item the FDA will pursue once the opioids legislation becomes law, the agency’s chief said Oct. 18.

President Donald Trump could sign the massive opioids bill the week of Oct. 22. The bill (H.R. 6) is in response to a public health epidemic that takes 115 lives a day in the U.S.

The legislation includes a new authority for the Food and Drug Administration to require opioid manufacturers such as Purdue Pharma and Johnson & Johnson to develop new packaging for the powerful painkillers, so opioids can be available in a smaller supply for just a few days. The goal of these packs is to prevent opioid addiction by eliminating the number of excess pills prescribed by doctors.

The new blister packs could change physicians’ prescribing practices by recalibrating the default supply of opioids provided in a prescription to last just a few days. Doctors were defaulting to prescriptions that supplied a week or a month’s worth of opioids, even for minor procedures, FDA Commissioner Scott Gottlieb said. “Nobody should be getting 30 days for a wisdom tooth extraction.”

The bill will nudge the entire health-care market to integrate existing digital tools and other technologies, such as electronic prescribing, in a way that he said will sharply cut down on the overall number of patients exposed to opioids and help limit overprescribing by tracking doctors’ prescription practices.

Gottlieb, who’s been calling for blister packs for opioids for at least a year, said he wants to move swiftly to implement this mandate once the president signs the bill and the authority becomes available.

“The first thing that we’re going to do is the blister packs,” Gottlieb said. He spoke during a Politco event on using technologies to combat the opioids and diabetes crises. The commissioner’s talk focused just on the opioids part.

About 2 million Americans suffer from a substance abuse disorder related to prescription opioids, according to data from the National Institute on Drug Abuse, part of the National Institutes of Health. About 80 percent of people who use heroin first misused prescription opioids.

“The rate of new addiction is a function of prescribing,” Gottlieb said. “This is a crisis that started in the medical setting.”

Craig Landau, president and chief executive officer of Purdue Pharma, maker of the brand-name opioid Oxycontin (oxycodone), told Bloomberg Law the company supports the initiative to offer blister packaging for opioids. “We are currently evaluating options to provide blister packaging for our sustained release opioid formulations,” Laundau said in an Oct. 18 email. “We appreciate Commissioner Gottlieb’s recent comments and leadership on this initiative.”

—With assistance from Alex Ruoff

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