Upton, Coburn Commend FDA’s Draft Guidance As Important First Step to Keep Non-Abuse-Deterrent Prescription Drugs From Hitting Market

January 9, 2013

WASHINGTON, DC - Energy and Commerce Committee Chairman Fred Upton (R-MI) and Senator Tom Coburn (R-OK) commended the Food and Drug Administration for meeting today’s deadline to issue draft guidance on abuse-deterrent prescription drugs. In late December, the leaders had requested the Department of Health and Human Services provide more information on its efforts to address the growing concerns surrounding the imminent release of abuse-deterrent versions of extended-release opioids, such as Oxycontin.

In the December letter to HHS, Upton and Coburn wrote, “During the past month, we have heard from a number of concerned citizens, including parents, law enforcement officials, health care providers, state and local officials, and our colleagues in Congress, about the impending release of the non-tamper-resistant versions of these opioids.  According to these concerned citizens, the release of the non-tamper-resistant versions will deal a significant setback to our nation’s ongoing struggle to stop prescription drug abuse.”

FDA Commissioner Margaret Hamburg echoed Upton’s and Coburn’s concerns yesterday in responding to their letter, writing, "Please be assured that HHS and FDA share your concerns, and those of your constituents, regarding prescription drug abuse, including the abuse of opioid analgesics. HHS and FDA are committed to finding ways to reduce abuse and misuse of these medications. As part of our ongoing mission to protect public health, FDA has concluded that if FDA determines that a formulation of a product significantly deters abuse, we have legal authority, under the drug approval and drug safety provisions of the Federal Food, Drug, and Cosmetic Act, to require generic versions of that product to have abuse-deterrent formulations as well."

Upton and Coburn commended FDA for meeting today’s deadline set forth in Section 1122 of the Food and Drug Administration Safety and Innovation Act of 2012 by issuing the draft guidance on abuse-deterrent opioids. The leaders stated, “The draft guidance represents an important step forward in understanding how the FDA will apply the science of abuse deterrence when evaluating abuse-deterrent opioid formulations. Prescription drug abuse is a real and constant struggle, and we look forward to working with the agency, law enforcement, health officials, and concerned parents across the nation to adopt policies that curb the abuse of powerful, non-abuse-deterrent prescription drugs.”

A copy of Upton’s and Coburn’s December 21, 2012, letter can be found here.

FDA Commissioner Hamburg’s response to can be found here.

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