The Latest Gems on REMS

  • by: |
  • 10/07/2015

From the fine folks at RAPS ...

FDA Launches Pilot to Standardize REMS Information for Easier Systems Integration

The US Food and Drug Administration (FDA) has announced a four-month pilot to make Risk Evaluation and Mitigation Strategies (REMS) easier to share and integrate with existing pharmacy and health information systems.


With the passage of the 2007 Food and Drug Administration Amendments Act, FDA was granted the authority to require manufacturers to develop REMS for new and approved products.

These plans are intended to enable companies to better manage known or potential risks their products carry, and may be required as a condition for approval.

Then in 2012, as part of the Prescription Drug User Fee Act (PDUFA) reauthorization, FDA agreed to take steps to "measure the effectiveness of REMS … standardize REMS, and with stakeholder input seek to integrate REMS into the existing and evolving healthcare system."

To fulfill these commitments, FDA in 2013 held a public stakeholder meeting on standardizing REMS, followed by an expert workshop which evaluated "current approaches in the design, development, implementation, and assessment of REMS, limitations of existing methods for the design of REMS programs, and existing approaches to identify, evaluate, and mitigate risks that can inform REMS design."

Pilot Project

Following the stakeholder meeting and expert workshop in 2013, FDA developed four "priority projects" related to REMS to tackle in the coming years.

Today's pilot announcement marks the launch of one of these priority projects, which is intended to integrate REMS into Structured Product Label (SPL) format, which will make it easier for these documents to be integrated into pharmacy and hospital IT systems.

FDA says that stakeholders have "expressed concern that information about REMS materials, tools, and requirements are not communicated … in a clear and consistent manner," and that "REMS materials and requirements may be difficult to locate."

The agency also says stakeholders have reported "difficulty integrating REMS materials and procedures into their existing … systems."

FDA says it believes this pilot will "address many of the concerns … regarding REMS because SPL information can be easily shared and made available online." The agency also says both it and manufacturers are already well-versed with SPL, which will make transitioning to the format fairly straightforward.

FDA says it is looking for no more than nine volunteers to take part in the pilot and asks interested parties to apply by 7 December 2015. The pilot project is slated to run from 6 October 2015 through 3 February 2016, and may be extended if necessary.

Federal Register


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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