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Bart's Corner: REMS Update

In September 2014 FDA issued a paper on Standardizing & Evaluating Risk Evaluation and Mitigation Strategy (REMS).

A REMS is put in place for those products to ensure that benefits outweigh the risks. REMS may require additional measures above and beyond the usual post-marketing safety surveillance by the sponsor.

This report has been released as part of FDA’s commitments, as required by the Prescription Drug User Fee Act reauthorization of 2012 (called PDUFA V) to continue to improve REMS to better protect the public health. FDA promised to develop techniques to standardize REMS by getting stakeholder input. The goal is to reduce the burden of REMS on practitioners, patients and others in the health care settings. Five areas are being looked at: providing patient benefit-risk information, prescriber education, pharmacy systems, and practice settings.

Three FDA working groups were set up to comply with the law’s requirements:

  1. The Policy Work Group: This group is developing a guidance on how FDA intends to use the statutory criteria to determine whether a REMS is needed or not.
  2. The Evaluation Work Group: This group is working to develop an evidence-based approach to assessing the effectiveness and burden of REMS and developing a guidance for assessing REMS’s effectiveness.
  3. The Design and Standardization Work Group: Identify the best practices to incorporate into future REMS design, tools and their integration into the US healthcare delivery system.

FDA held multiple public meetings in 2013 and issued this report in September 2014.

The feedback and high level findings include (my comments in italics):

Four key projects were defined and put in place:

  1. Providing better patient benefit-risk information under REMS by improving tools for prescriber to patient counseling

Author’s comment: This is indeed a laudable and necessary project not only for REMS but also for medical communication in general. When a patient fills a prescription he or she will often get (whether in the pharmacy or by mail) either the professional package insert (PI) or a long, single spaced, small font highly technical document largely derived from the PI. Some are hard to read even for the HCP, let alone the patients. With the arrival of social media and patient oriented websites, one hopes we will see significant new and improved means of getting the key risks (and benefits) across to patients perhaps by tweets, SMS or other modern means.

  1. Providing prescribers better continuing education on REMS

Author’s comment: Certainly reasonable but not sure that this is the best or only way to get the education points across. Perhaps many of the tools in the first project on patient counseling can be adapted for HCPs. Again, maybe social media will have a big role.

  1. Standardizing REMS information for inclusion in pharmacy systems using Structured Product Labeling (SPL)

Author’s comment: Again highly laudable and quite workable. It is rather complex and time consuming for the labeling of all US products. As there are fewer REMS, this should be more doable in a shorter length of time. Standardization of content and format is something that governments are generally quite adept at. Getting agreement amongst the parties, including the information technology requirements, may be a bit harder if systems must be redone at significant cost.

  1. Provide a central source for REMS information for practice settings

Author’s comment: Laudable and should be fairly easy to do.

If you wish to see more about each of these projects, have a look at the document itself. It is a very positive sign that FDA is clearly not frozen in place with REMS as they currently exist, and is collecting input from stakeholders with the goal of making the whole concept and process better.

As the engineers say, “if you can measure it, you can fix it”. It certainly seems that we can measure outcomes of some or most of the REMS to see whether they are really working. From this there will be lessons to be learned and changes to be made. The only mildly disquieting issue (to me at least) is the time involved in all of this. REMS have been in place for a number of years. It took FDA all of 2013 to get this feedback and then about a year to write this report on only one of the working groups. One would hope that the process can be sped up (presuming that the will and the funding to do so are available).



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