FDA Advisors Reject Agency Plan to Control Opioid Use as Too Soft

One reason opioid use is so prevalent is because of unscrupulous doctors who are quick to dole out prescription narcotics said Dr. Roland Gray, director of the Physicians Health Program at the Tennessee Medical Foundation in Brentwood, Tenn.

"They don't need a course in writing prescriptions, they need a course in ethics," said Gray. "If they don't have a conscience, we can't give them that."

That's beyond the scope of the FDA, said John Jenkins, MD, director of the agency's Office of New Drugs.

"The REMS cannot address the entire scope of the problem of prescription abuse and misuse," Jenkins said.

Physicians and nurse practitioners who prescribe certain opioids already have to register with the DEA, and some panelists favored linking that registration to completion of a training program. That approach, too, is out of the purview of the FDA and would require an act of Congress.

In a press briefing following the meeting, Jenkins told reporters that the FDA could work with its parent agency, the Department of Health and Human Services, to craft legislative language. Or a member of Congress could introduce a bill that would require any prescriber registering with the DEA to undergo opioid training.

About 700,000 physicians prescribe opioids for about 4 million patients, so creating such registries would be an epic undertaking, Dr. Bob Rappaport, director of the FDA's division of anesthesia and analgesia products, wrote in briefing documents released in advance of Friday's hearing.

Another problem the panel had with the FDA's proposal is that it governs only extended-release opioids, which are responsible for more overdoses than immediate release opioids. The panel felt that a REMS should govern immediate-release opioids as well.

"If we don't include immediate release products, we'll be back in two years discussing another REMS," said panelist Patrick Beardsley, professor of pharmacology and toxicology at Virginia Commonwealth University.

The FDA announced it would implement a REMS for opioids in February 2009, and held a public meeting a few months later during which physicians, patients, pharmacists, hospice workers, addiction groups, and others voiced their views on what moves the agency should make.

A number of members of the public who spoke at that meeting urged the FDA to also require patients who take opioids to sign a registry. The panel didn't discuss that idea.

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