FDA Prepares to Walk the Opiate REMS Line

Attendees at FDA’s meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees in late July will be armed with the agency’s 374-page “brief”-ing on a possible Risk Evaluation and Mitigation Strategy (REMS) for prescription opioids. The briefing is an exhaustive catalog of comments and concerns raised by various industry thought leaders, pain management groups, and healthcare professionals (HCPs), as well as containing input from patients themselves.

FDA puts the number of Americans suffering from chronic, non-cancer–related pain at anywhere from 25 to 33 percent of the population. And the use of opioid analgesics as treatment for chronic pain conditions such as fibromyalgia has soared in the last decade-as has the incidence of opioid abuse.

In this case, curbing abuse is part of the rationale behind REMS. Stricter prescribing guidelines and increased efforts toward physician, pharmacist, and patient education are all proposed in the briefing. The idea is to weed out potential abusers-though many get their drugs secondhand, as several comments point out.

There is also a possibility that measures to restrict access to opioids will lead to undertreatment of chronic pain, particularly in rural areas, and that such scrutiny will scare away patients, leading them to settle for less effective drugs. Similarly, the proposal that FDA put a temporary ban on extended-release (ER) and long-acting (LA) opioids was met with vehement opposition, even though the agency has noted the need for exceptions.

Any REMS would have to focus on ER and LA formulations of drugs like hydrocodone, oxycodone, and morphine. The immediate-release formulations hold less abuse potential, since they’re rarely prescribed with refills.

But before the committees even begin to hash out the details of REMS, a decision must be reached about whether or not there is reason enough for FDA to implement it-or if the agency even has the authority to do so. Comments suggest these responsibilities lie in DEA’s territory, or with the manufacturers themselves, and because the incidence of abuse is so small a fraction of total prescription, a potential REMS could do more harm than good.

With all the conflicting comments and data, the committees are in for a grueling two days. But the results will help set a precedent for FDA-mandated REMS to come.