FDA Panel Rejects REMS for Opioids, Says Current Plan Inadequate

Allison Gandey

July 23, 2010

July 23, 2010 — A US Food and Drug Administration (FDA) panel has voted overwhelmingly against the controversial opioid risk evaluation and mitigation strategies known as REMS. The 25 to 10 vote against the proposal sends 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.

Committee members told regulators today to toughen up new recommendations.

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.

"I voted no," committee chair Jeffrey Kirsch, MD, from the Oregon Health and Science University in Portland, 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.

This was a view echoed 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.

Continuing the status quo is unacceptable.

Herbert Neuman, MD, vice president of medical affairs and chief medical officer at Covidien Pharmaceuticals, told Medscape Medical News he believes the FDA's proposal was moving the field in the right direction. "It's important we strike a balance between access, safety, and prescriber choice," he said.

Dr. Neuman addressed the advisory committee with regard to Covidien's recent REMS experience with hydromorphone extended-release (Exalgo). During an interview after his talk, he added, "It's important we don't place undue burden on the healthcare system or stigmatize patients with new recommendations that have unintended consequences and upset the balance," he said.

"We are not currently in balance," committee member John Markman, MD, from the University of Rochester Medical Center in New York, said at the meeting, citing the huge public health problem with opioid misuse and abuse. "We are very much out of balance, and continuing the status quo is unacceptable."

The FDA proposal also concentrated 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 immediate-release and extended-release formulations have a huge impact on public health," Dr. Kirsch said.

Call for Drug Enforcement Administration Involvement

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.

Seddon Savage, MD, president of the American Pain Society, recently told Medscape Medical News she agrees with Drug Enforcement Administration involvement. "It isn't something we can do immediately, and it would require legislative changes, but this is the best long-term solution."

Committee members also went on record today advocating 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 Knox Todd, MD, from the Beth Israel Medical Center in New York City, said at the meeting. "And delayed action would be unacceptable."

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