An American Academy of Pain Medicine Press Release

FDA REMS on Opioids

May 22, 2009 -- The Food and Drug Administration initiated a process last fall largely outside the notice of most physicians that could have a profound affect on how extended-release medications, including morphine, oxycodone, and methadone, are prescribed for pain relief. The medical community, including AAPM, has now taken a more active role in that process in an effort to ensure that any decision reached by the FDA considers the needs of legitimate pain medicine prescribers and their patients.

S 660 authorizes an Institute of Medicine Conference on Pain Care, promotes pain research at NIH, provides comprehensive pain care education and training for health care professionals, and institutes a public awareness campaign on pain management. Introduced by Sens. Orrin Hatch (R-UT) and Christopher Dodd (D-CT), S 660 has been referred to the Senate Committee on Health, Education, Labor, and Pensions.

Under a mandate from Congress to reduce the morbidity and mortality associated with the abuse, misuse, and diversion of prescription drugs, the FDA decided in November that the manufacturers of all extended-release opioids would be required to submit what is referred to as a Risk Evaluation and Mitigation Strategy (REMS) when seeking FDA approval to sell a drug in that class. Under federal law, a REMS is required where the FDA is concerned that a drug’s risks might outweigh its benefits and would typically include a medication guide, a patient package insert, a communication plan, elements to assure safe use, and an implementation system.

To begin the process of determining what would be required in the REMS for opioids, the FDA in February invited 16 drug manufacturers to a March 3 meeting. The medical community, upon learning of the meeting, asked the FDA for a second meeting so that it could provide input. The FDA agreed to a meeting on May 4 in Washington, D.C.

On April 29, medical community representatives, including Scott Fishman, MD, an AAPM director at large, and Phil Saigh, AAPM’s executive director, met at the American Medical Association headquarters in Washington, D.C., to prepare for the May 4 meeting, to discuss their response to the FDA, and to set priorities for what they thought should be in the REMS. The representatives agreed to three priorities:

(1) A prescription monitoring program (PMP) should be developed that would provide physicians with accurate, real-time data on opioid prescriptions so that a physician would have access to a patient's prescription drug history before prescribing the opioid. Approximately 38 states have a PMP, with varying degrees of success. The goal would be to use the elements of existing PMPs that have proven most successful to create PMP standards that the states could use to draft PMP-enabling legislation or to modify the existing PMP. Ideally, the various state databases would be linked to prevent abusers and misusers from jumping across state lines to get new prescriptions. New patient registries, on the other hand, should not be a part of the REMS because they are generally ineffective in stopping drug misuse and abuse, and they raise privacy concerns.

(2) The FDA should use the REMS to target all opioids rather than limit the REMS to slow-release opioids. The danger in limiting the REMS to slow-release opioids is that if the process of prescribing slow-release opioids were to become more cumbersome than other types of medication, physicians will migrate to short-acting opioids, options will be limited, and healthcare quality will suffer.

(3) Education programs should be developed to help everyone involved understand the issues when prescribing opioids, including physicians, pharmacists, and patients. The education should include all related matters, including how to properly use the PMP. And, most importantly, the education program should be developed with significant input from experts in the field.

"We think the best approach," Dr. Fishman says, "is to work to prevent the problem from occurring rather than waiting until after it has occurred." PMPs are a key part of that approach, and AAPM hopes that the FDA will support PMPs, perhaps by using some of the fees they collect from drug manufacturers to help fund PMPs, and that they will urge drug manufacturers to support PMPs directly. National All Schedules Prescription Electronic Reporting (NASPER) is a currently underfunded federal law designed to provide financial assistance to state PMPs, so the mechanism for channeling money to states for PMPs is already in place.

At the May 4 meeting, attended by Perry Fine, MD, AAPM treasurer, and Phil Saigh, the medical community shared its priorities with the FDA, whom Dr. Fine described as being "incredibly responsive" and "genuinely trying to figure out how to get the job done." The FDA, Dr. Fine said, has been put in an especially difficult position because it has been ordered to reduce mortality from opioid misuse, yet it has no leverage other than forcing drug manufacturers to submit a REMS.

A genuine solution, he says, would not be achieved until the full range of agencies with jurisdiction in this matter-the Centers for Disease Control and Prevention, the National Institutes of Health, the Institute of Medicine, the National Institute on Drug Abuse, etc.-are brought into the discussion. In addition, the problem cannot be solved, he says, until we are able to understand the root causes of why people abuse and misuse the prescription drugs, an analysis that would have to take place in a different forum.

In the meantime, the most important step that can be taken is to make sure that the requirements for the FDA's REMS are appropriately crafted. From AAPM's perspective, that would be "ensuring that the REMS is created with the best interests of the patient in mind," Phil Saigh says. "We must find a proper balance between the war on drugs and the war on pain." Dr. Fine warns that "the REMS must not impose rules so complex and onerous on that they have a chilling effect on prescriptions."

AAPM representatives will continue to work to ensure that the REMS considers the needs of the medical community. They will continue to meet with the FDA and with other stakeholders, to testify in Congressional hearings if called upon, and to do whatever else is necessary to ensure that legitimate prescription practices are protected.