FDA takes a relatively non-restrictive preliminary position on opioid REMS

Pharmaceutical CommercePharmaceutical Commerce - July/August 2010

‘Class-wide’ REMS policy will involve patient and prescriber education, but no registry or restricted distribution at this time

Over a year ago, FDA kicked at the underpinnings of the opioid-based pain market with a call for REMS program for the extended-release versions for the entire therapeutic class. Now, in a preliminary policy guidance that will be reviewed at a July advisory committee, the agency is taking its first public steps toward establishing their policy. The document, “Risk Evaluation and Mitigation Strategies (REMS) for Extended-Release and Long-Acting Opioid Analgesics,” synthesizes over 2,000 comments the agency received, and represents the concerted effort of over 70 FDA employees over the past year in seven distinct working groups within the agency, according to a letter sent by Dr. Bob Rappaport, director of FDA’s Div. of Anesthesia and Anesthesia Products in CDER.

For all the commenting and analysis, FDA’s initial recommendations are relatively mild: a medication guide; an “elements to assure safe use” (ETASU) responsibility; and a timetable for assessing the program’s progress that will be based on yet-to-be-established data sources and metrics with “sponsors” (i.e., manufacturers of said drugs). The ETASU portion will include patient and prescriber education, but there will not be a requirement for certifying this training, or for maintaining a registry of trained patients. By comparison, a fast-acting opioid approved last summer requires registries of certified distributors, pharmacists, prescribers and patients, and a signed receipt when the drug is delivered by courier to the patient’s home.

Unlike the more-than-100 REMS programs that have been instituted in the past couple years, which usually accompany single drugs of (often) limited distribution, the opioid-class REMS will involve nearly 20 manufacturers, and drugs that are prescribed in the tens of millions of scrips annually, by more than 700,000 DEA-registered prescribers.

The FDA backgrounder reviews the thousands of comments received, ranging from patient-support groups, to medical associations, to families who experienced personal tragedy from misuse or abuse of opioids, which have been tied to 30,000 hospital visits (and a cost of $700 million) in 2007, and more deaths than all illegal drug abuse combined. But advocates for cancer and other pain-management support groups cautioned against restricting access to the drugs; even a veterinary group chimed in, noting that these opioids are prescribed to animals.

The joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will be held on July 22-23 in Adelphi, MD.

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