Since 2007, the US Food and Drug Administration (FDA) has utilized a set of tools formally known as Risk Evaluation and Mitigation Strategies (REMS) to control and ensure the safe use of dangerous or potentially dangerous drugs. Now the agency says it is looking to make changes to one of the program's more lenient categories, potentially offering companies more-and simpler-options to comply with federal requirements.
REMS were first introduced under the 2007 Food and Drug Administration Amendments Act (FDAAA), and were meant to act as a regulatory hedge against potentially risky products-the answer to the question of how to keep drugs with known risks out of the hands of populations where they might do the most harm while still keeping them available to patients who could benefit from them.
REMS typically include the following elements: A communication plan, Medication Guides (MedGuides), an implementation plan and elements to ensure safe use (ETASU) of the drug.
ETASU's are REMS' most stringent requirements and include prescriber requirements, enrollment forms, training materials, process controls, consent forms, safety controls and monitoring programs. Some REMS will only include one or two of these elements, while others, such as isotretinoin, may include nearly all of them.
But ETASUs are generally only appropriate for the riskiest products, such as those known to cause birth defects. For many other drugs, a communication plan is more appropriate. A communication plan under a REMS usually includes "Dear Healthcare Professional" letters, widespread dissemination of information to professionals through other communications and fora, and specific information about the REMS intended to inform good prescribing practices.
The plans are, at their core, intended to communicate risks and the methods by which they can be minimized. As of 26 November 2013, FDA has approved 30 communication plans as part of an actively approved REMS (others have since been released from their REMS requirements).
REMS are also required to include assessment plans, which are intended to show whether a REMS plan is working as intended to mitigate risks. If a study shows that a REMS approach is not working, FDA may require it to be strengthened or the drug pulled off the market. These plans, however, have been identified as being faulty by government auditors.
New Options Possible?
Now FDA says it wants to discuss whether "new methods" of communication plans might be appropriate and, regardless of whether they are, how the agency can best evaluate the effectiveness of approved communication plans.
The 26 November 2013 Federal Register notice follows a series of other notices and meetings on REMS, indicating FDA is in the midst of numerous changes to the program. In May 2013, for example, FDA announced that it is considering standardizing the format and assessment process for REMS, such as the class-wide REMS policy now in effect for opioids. The goal, FDA said, was to make REMS more efficient and less onerous on sponsors.
Taken together, FDA's new notice might represent an additional olive branch to industry, which has long complained the REMS process is unnecessarily difficult. If communication plans can be strengthened and shown to be working, FDA might be more willing to rely on communication rather than control.
No questions from regulators have yet been made available. FDA has said only that it wants to " address how sponsors and FDA can evaluate whether REMS communications are reaching the targeted population, are increasing awareness and understanding of the key risk messages, as well as whether the communications are having the intended impact on knowledge, behaviors, and/or outcomes."
The meeting will be held on 17 December 2013 at FDA's White Oak Campus in Maryland.
Federal Register notice