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FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions

Michael Mezher
RAPS.org
24 March 2016

The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their brand-name counterparts for public comment on Thursday.

The new draft guidance is part of a wider effort by FDA to address the national opioid epidemic, which claimed the lives of more than 28,000 Americans in 2014.

In February, the agency detailed its opioids action plan, saying it would require advisory committee meetings for all new opioid drugs that lack abuse-deterrent properties, strengthen warnings for all immediate-release formulations and increase postmarket requirements to include new studies and updated risk evaluation and mitigation strategy (REMS) requirements for opioids.

While introducing the draft guidance, FDA Commissioner Robert Califf emphasized the importance of opioids in pain management, saying, "For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option."

Califf then stressed the role of abuse-deterrent formulations in the overall response to the epidemic, saying, "We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy”…

http://www.raps.org/Regulatory-Focus/News/2016/03/24/24629/FDA-Generic-Opioids-Must-be-No-Less-Abuse-Deterrent-Than-Brand-Name-Versions/#sthash.hGHZolEg.dpuf

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