Posted 22 September 2014
By Alexander Gaffney, RAC
The US Food and Drug Administration (FDA) soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs—a collection of restrictions meant to protect patients from potentially dangerous drug products.
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 for almost as long as REMS have existed, pharmaceutical manufacturers have complained that they are inefficient, cumbersome and onerous. For example, because most REMS are based on a specific drug, and not a wider drug class, the creation of a REMS plan can be long and costly for a company to develop and implement.
Change: What, When and How?
For several years, FDA has been considering how it might change the program to address some of those criticisms. For example, in July 2013 FDA held a meeting on "standardizing and evaluating REMS" programs, at which it discussed how to standardize when REMS are required, the elements REMS plans would require and how REMS are integrated into the healthcare system.
Now FDA is moving its efforts one step beyond the discussion stage. In a Federal Register announcement on 22 September 2014, the agency announced that it will shortly begin work on four pilot programs as part of its commitments under the Food and Drug Administration Safety and Innovation Act (FDASIA) to "measure the effectiveness of REMS and standardize and better integrate REMS into the healthcare system."
"Stakeholders indicated that they want flexibility to implement a REMS program based upon the nature of the health care setting," FDA noted in its announcement. In particular, sponsors want the flexibility to tailor their REMS communications to their intended audience. Sponsors characterized current communications as "inadequate, inconsistent, unclear or too difficult to access, navigate and digest," FDA recounted.
Industry would also benefit from a better structure for REMS documentation, such as through the use of the XML-based structured product labeling (SPL) format, which is now used for most other regulatory filings at FDA, companies said. Other stakeholders advocated for the use of human factors evaluation methods "that might be deployed to help to develop criteria for levels of risk that could prompt regulatory action," FDA explained.
New REMS Projects Seek Greater Standardization, Usability
FDA's notice takes these comments to heart by announcing four REMS-focused projects intended to address industry's criticisms.
In the first project, "Providing Benefit-Risk Information to Patients," FDA said it wants to "improve the tools used for prescriber-to-patient counseling about REMS drugs."
"To that end, FDA proposes to conduct research into existing REMS patient counseling tools, other patient counseling initiatives, and counseling literature to identify current tactics and strategies for patient counseling about medication benefits and risk," the regulator said. Its findings will form the basis of a public report "that could serve as the basis for designing new tools," it added.
The second project will focus on "prescriber education," and will seek to assess "whether it is feasible to provide continuing education (CE) … associated with a specific REMS." A third program will seek to integrate REMS documentation into the SPL format, which FDA hopes will allow it to be better integrated into pharmacy systems and health IT systems.
A fourth project, "Practice Settings," will seek to build a "centralized, standardized, reliable and user-friendly repository of information about REMS, including stakeholders' specific activities and requirements under each REMS program." The repository will take the form of a web page, FDA said.
FDA provided no information about how much funding would be put behind the four projects, but additional information is said to be coming in a report to be published on FDA's website later this month. Project updates will be posted to the agency's website as well, it said.
Comments on the project are due by 23 November 2014.