Pain Management

  • by: |
  • 01/23/2013

The Drug Enforcement Administration has once again asked the FDA to consider tightening prescribing and other rules on hydrocodone drugs.

Proving, once again, that the DEA doesn’t understand the problem. Denying access to patients in pain (the unintended but obvious consequence of up-scheduling) does nothing to stop those who provide hydrocodone – via inappropriate prescribing or illegal means.

The FDA will hold hearings tomorrow and Thursday to consider whether to move hydrocodone products from schedule III to the more highly regulated schedule II class under which narcotics such as OxyContin (oxycodone) fall. In a briefing document released as background material, FDA scientists said that although "patients taking hydrocodone products might develop moderate or low physical dependence, they would not be expected to develop addiction."

This is regulatory-speak for not wanting to change the classification.

CDER Deputy Director Dr. Doug Throckmorton said an analysis conducted internally by scientists at the agency does not reflect the FDA's "official stance." He said the agency will refrain from making recommendations until after it has reviewed testimony and received a recommendation from the independent advisory committee, which scheduled the two-day hearing.

This is regulatory-speak for, “we know what we want to do – but we want to solicit informed opinion."

Please step up to the microphone and state your name.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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