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News and Innovations

On July 23, 2010, a U.S. Food and Drug Administration (FDA) panel voted against the controversial opioid Risk Evaluation and Mitigation Strategies known as REMS. The 25 to 10 vote against the proposal sent a strong message to regulators that new recommendations will require more teeth. Most committee members said safety measures for opioids are urgently needed, but voiced concern that the current approach does not go far enough to protect the public. Drug overdose death rates in the United States are at an all-time high. According to some reports, there are more deaths from opioid overdoses than from heroin and cocaine overdoses combined. In some states, these rates are higher than deaths from automobile accidents. In addition to the clear human costs, an estimated 60% of hospital costs related to opioid overdoses are paid for with public funds. The FDA dropped a number of earlier ideas such as prescriber accreditation and patient registration programs. Bob Rappaport, MD, from the office of drug evaluation, said those plans were left out of the proposal because of concerns over how onerous it might be to track an estimated 700,000 prescribers. Some patients, he said, also complained about possible registration requirements. Prescriber education is in the proposed plan, but regulators decided it would not require any formal enrolment or real-time verification of training. Committee chair Jeffrey Kirsch, MD, from the Oregon Health and Science University in Portland who voted against the proposal said at the meeting. “I fully support that REMS is a critical requirement of provider learning, but these initiatives will need to establish definite competencies and assessments,” he said. Similar sentiments were expressed by the majority of the unusually large 35-member advisory committee. Regulators brought together members from multiple committees to tackle this important issue, which is expected to affect an estimated 4 million patients. The FDA proposal focused on extended-release and long-acting opioids. It was a focus that did not sit well with many committee members, who raised concerns about the risk with immediate-release formulations. Many suggested both product groupings be included in future safety initiatives. “Both immediaterelease and extended-release formulations have a huge impact on public health,” Dr. Kirsch said. FDA officials have long suggested that linking education to the existing Drug Enforcement Administration registration system would help ensure appropriate education of physicians, but this would require legislation. Committee advocated for legislative changes to assist the FDA. Many agreed the overwhelming public health problem is in part beyond the regulatory controls of the FDA and will require a multipronged approach. “I think we can all agree that doing nothing is not an option,” Committee member and Journal Editorial Board member Knox Todd, MD, from the Beth Israel Medical Center in New York City, said at the meeting. “And delayed action would be unacceptable.”