Today, during a Capitol Hill briefing sponsored by the Congressional Caucus on Prescription Drug Abuse, Congressman Harold "Hal" Rogers (KY-05) prodded the Food and Drug Administration (FDA) Commissioner Margaret Hamburg to significantly beef up the FDA's efforts to combat our country's fastest growing drug threat. The briefing coincided with Rogers' co-sponsorship of the STOPP (Stop the Tampering of Prescription Pills) Act, legislation to encourage drug companies to develop technologies that make opioid narcotics harder to abuse by crushing, snorting or injection. The bipartisan bill was introduced by Rx Caucus Members Mary Bono Mack (CA-45) and Bill Keating (MA-10).
"Over 16,000 people lost their battle with addiction to these potent painkillers last year, while drug manufacturers raked in billions of dollars," stated Rogers, Co-Founder and Co-Chairman of the Congressional Caucus on Prescription Drug Abuse. "While their products can make a world of difference for patients in dire need, drug companies absolutely must take seriously the need to develop tamper-proof pills and help stop the cycle of addiction. We need the FDA to do its part and Congress can fill in the gaps. The STOPP Act will empower FDA in approving tamper-resistant prescription pills and help thwart the alarmingly increasing rates of addiction."
In addition to discussing the importance of tamper-resistant formulations for opioid painkillers, Rogers expressed his staunch opposition to applications pending at the FDA which would allow drug-makers to produce a generic formulation of the powerful drug OxyContin, once Purdue Pharma's patent expires in 2013. Purdue voluntarily removed the original OxyContin from the market in 2010 after being found criminally liable for deliberately misbranding the product; the company reissued with drug with a formulation that is more resistant to tampering. When considering whether to approve the generic applications, FDA must make a legal determination about whether the original formulation was removed for "reasons of health and safety." The STOPP Act would therefore provide a legal pathway for FDA to reject the approval of generic drug companies' application to market the original OxyContin formula.
"Obvious issues with diversion and abuse could arise if this drug is available in a cheaper, generic form, and I'm afraid we'll experience a new wave of overdose deaths" stated Rogers. "Aside from the human toll, this would be a tremendous setback to companies developing other tamper-resistant pain medications. If generic OxyContin is available on the market for a low price, there is little financial incentive for these companies to invest in the development of tamper-resistant drugs."
Finally, Rogers discussed the need for stricter requirements for prescriber education. In July, FDA finalized its much-anticipated "Risk Evaluation and Mitigation Strategy" (REMS) for Extended Release, Long Acting (ER/LA) opioids. REMS compels drug companies to support the development by third-parties of training programs for prescribers that includes information on weighing the risks and benefits of opioid therapy, choosing patients appropriately, managing and monitoring patients, counseling patients on the safe use of these drugs, and how to recognize evidence of, and the potential for misuse or addiction. While this training will be available to the 320,000 prescribers of ER/LA painkillers by March 2013, doctors will not be required to participate by REMS. Rogers expressed his continued support for a mandatory prescriber education program and pressed Dr. Hamburg to ensure that physicians are well informed and can properly monitor their patients. Rogers is a co-sponsor of the Ryan Creedon Act, a mandatory prescriber education bill which would require healthcare professionals to learn about risks associated with controlled substances prior to DEA granting prescribing authorities