Investment Research and Business Due Diligence
Tuesday, March 26, 2013
New Legislation Proposes to Limit Approved Uses for Controlled Release Oxycodone-Hydrochloride for Relief of “Severe-Only” Pain
On Thursday, March 21, 2013, Representatives Harold “Hal” Rogers (R. Ky.), who is the co-founder and co-chairman of the Congressional Caucus on Prescription Drug Abuse, and Stephen Lynch (D. Mass) introduced the
Stop Oxy Act of 2013
(H.R. 1366). The legislation seeks to direct the Commissioner of the FDA to modify the existing and future approval of any drug containing controlled-release oxycodone hydrochloride under section 505 of the FDCA (21 U.S.C. § 355) to limit such approval to the relief of “severe-only” instead of “moderate-to-severe” pain.
The Stop Oxy Act comes on the heels of a recent
(Docket No. FDA-2012-P-0818) filed by the Physicians for Responsible Opioid Prescribing (“PROP”) urging FDA to modify the labeling for opioid analgesics. Specifically, similar to the legislation, the PROP petition requests that FDA “strike the term ‘moderate’ from the indication for non-cancer pain.” It further requests that FDA “add a maximum daily dose equivalent to 100 milligrams of morphine for non-cancer pain;” and “add a maximum duration of 90-days for continuous daily” use for non-cancer pain. While some states do place quantity or duration limitations on prescriptions for certain controlled substances, currently there are no similar federal limitations. The PROP petition asserts that such changes are necessary because, among other reasons, long-term safety and effectiveness of managing chronic non-cancer pain with opioids “has not been established.” Furthermore, the petition notes that recent surveys found high rates of addiction in chronic non-cancer pain patients receiving chronic opioid treatment; and chronic opioid treatment “at high doses is associated with increased risk of overdose death, emergency room visits, and fractures in the elderly.” Interestingly, the House bill excludes the PROP petition’s “non-cancer” limitation, and, thus, seeks to restrict the approved use of controlled release oxycodone hydrochloride to “severe-only pain” in all patient populations.
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