FDA Gets Tougher on New Painkillers in Light of Overdoses

Robert Califf, President Barack Obama's nominee to lead the Food and Drug Administration, testified in Washington in November. PHOTO: PABLO MARTINEZ MONSIVAIS/ASSOCIATED PRESS

New opioids to go before outside committee unless they have abuse-deterrent properties


WASHINGTON—The Food and Drug Administration, hoping to reduce deaths related to the abuse of powerful painkillers, said it would insist that new versions of the drugs get tougher scrutiny and that manufacturers gather evidence about their effects once they are on the market.

The changes were announced by Robert Califf, the FDA’s deputy commissioner and the White House’s nominee to become commissioner.

Dr. Califf said the agency is acting now because “we’re not winning the battle at this point. We know we have a problem.” It is estimated that nearly 200,000 Americans have died from prescription painkiller overdoses since 1999.

The FDA actions include requiring that any new opioid go before an outside committee of experts unless the product has abuse-deterrent properties.

The agency also said it would require more warnings and safety information on drug labels and require makers to generate “post-market data on the long-term impact of using extended-release and long-acting opioids.” Doctors say these forms carry huge doses and thus are potentially more dangerous for people who abuse them.

The FDA and the industry have said that there is a genuine need for powerful drugs that can deal with severe pain, such as that caused by cancer or surgery. But they are prone to abuse and addiction, and when that happens, they can cause severe respiratory depression and death. Several versions approved in the last few years are designed to thwart abuse.

The FDA often has had to perform a delicate balancing act in making these narcotics available for patients with chronic severe pain while also somehow limiting their potential for abuse. The way it has struck that balance hasn’t satisfied many doctors who deal with drug abusers, nor has it been enough for some prominent public officials.

Sens. Joe Manchin (D., W.Va.) and Edward Markey (D., Mass.) have placed holds on the White House’s nomination of Dr. Califf to become FDA commissioner as a way to protest the agency’s handling of the opioid issue.

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