Statement from Ralph G. Neas, President and CEO, GPhA on FDA Decision on Abuse-Deterrent Formulations of OxyContin

APRIL 17, 2013
PRESS RELEASE

WASHINGTON, DC (April 17, 2013) — “We share the Agency’s goal of addressing prescription opioid abuse, and using a science-based approach to take on this complex problem. At the same time, we recognize the importance of balancing patient access to medicine with efforts to minimize abuse.

Yesterday’s decision from the FDA provides clear guidance on what is considered an abuse-deterrent formulation for OxyContin, information that GPhA and its member companies have been seeking since 2010.

Along with the draft guidance on abuse-deterrent formulations made available in January, this represents a beginning for other brand and generic manufacturers seeking to create these formulations.

We will continue to work with FDA to make progress on this front, contributing our comments to the public commentary period to hone the standards, and offering our manufacturers’ perspective.

As the science of abuse deterrence evolves, we look forward to making contributions to this new field.”



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