As REMS Requirements Simplify, Participants Need To Catch Up.

For more than three years, regulators at the U.S. Food and Drug Administration worked to hammer out a common risk evaluation and mitigation strategy (REMS) program for extendedrelease and long-acting opioids. These pain medications have a long history of abuse and each has had a REMS of its own. Now, with the FDA’s release of a comprehensive REMS program in July, 20 manufacturers have a common approach to education support for physicians who prescribe these drugs. The umbrella REMS program for pain therapies fits neatly into the FDA’s revised approach to safety requirements with an eye to simplifying the rules of the game — this is important as new complex biologics hitting the market qualify for detailed REMS programs. Congress established the REMS requirement in 2007 when drugrelated safety issues prompted legislators to mandate that the FDA require a REMS every time a manufacturer needed to go beyond labeling requirements to help healthcare professionals and patients manage potential serious risks. Some product-specific REMSs were simple. Others came with a host of steps that challenged even the best compliance efforts of physicians and patients. Under the new REMS program requirements, the FDA may simply want a medication guide added to the prescribing information to help patients understand how the drug works, how to take the drug, and what the side effects could be. More complex medications will require a program in which conditions of safe use must be tracked (e.g., blood levels or pregnancy test results), and product distribution tied to those conditions. To evaluate whether a REMS is achieving its intended goals will require assessments that involve surveying stakeholders and tracking communications outreach and other metrics specific to the design and goals of the REMS program. For example, when phenterminetopiramate (Qsymia) was approved — the first new weight-loss drug in more than a decade — the FDA spelled out an exacting REMS. The drug is available only through certified mail order pharmacies, which are required to hand out detailed medication guides that highlight risks. The drug is linked to deformities in newborns, so doctors who prescribe it to women of childbearing age must have a negative pregnancy test in hand before they prescribe the first dose. And physicians are given careful instructions on how to counsel patients.