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Regulatory Focus™ > News Articles > FDA Announces Meeting Intended to Start Standardization Process for REMS

FDA Announces Meeting Intended to Start Standardization Process for REMS

Posted 21 May 2013 | By Alexander Gaffney, RAC

US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product.


REMS were first introduced under the 2007 FDA 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, an implementation plan, and elements to ensure safe use (ETASU) of the drug. The latter is basically what most people associate with the plan, and includes 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.

Recent Developments

FDA has recently taken steps toward the consolidation of certain REMS elements. In July 2012, for example, it announced its approval of a new class-wide REMS policy to cover all long-lasting (LA) and extended-release (ER) opioid products on the market. That policy is intended to incorporate common training elements for prescribers, such as information on how to weigh the risks and benefits of opioid therapy, appropriate patient selection for opioid therapy, managing patients, and counseling patients on appropriate and safe use of opioid products.

The move had long been anticipated by industry after FDA noted in December 2011 that it would be formulating a class-wide REMS program for all opioid products. The move was announced in a 29 December 2011 news release approving a shared REMS system for transmucosal immediate-release fentanyl (TIRF) products, which was seen as perhaps providing the model for later shared REMS classes. As with the July 2012 announcement, FDA's December 2011 TIRF REMS focused on "educating prescribers, pharmacists and patients on the potential for misuse, abuse, addition and overdose."

But a question remained for industry: Was this a one-off change, or a trial balloon meant to test further consolidation amongst REMS plans?

A New Meeting

Now FDA is moving to answer that question with several of its own, holding a two-day meeting in July 2013 to standardize the REMS process based on the input of industry.

In its Federal Register announcement regarding the notice, FDA said the move was prompted by its commitments under the FDA Safety and Innovation Act (FDASIA), in which it promised to help make REMS plans more efficient and less burdensome on sponsors. The agency isn't starting from scratch, however. It notes that it has already held several meetings on elements of REMS, having reacted to strong industry backlash complaining about the lack of consistency associated with the process.

FDA said the meeting is also prompted in part by a February 2013 report that claimed that the agency lacks sufficient data to determine whether REMS are actually effective at ensuring product safety.

FDA said it is now seeking feedback on how to "reduce any unnecessary variation in REMS." The key word there is unnecessary, FDA added, noting that many variations are appropriate due to the specific risks posed by specific drugs.

"However, FDA may be able to establish standards to reduce unnecessary variation and to make REMS more predictable and simpler to understand, implement, and measure," FDA explained. "The establishment of standards also presents the opportunity to improve upon the design of REMS elements and associated tools and assessment methodologies in the future."

Questions for Industry

FDA's Federal Register notice says it has a number of questions for industry, including:

  • Can some prescriber training materials, approaches and assessments be standardized?
  • Are prescriber certification forms easy enough for prescribers and patients to understand, and can they be streamlined or otherwise simplified?
  • How can prescriber- and patient-directed REMS tools be standardized, made more efficient, and more useful?
  • What other technologies and tools should FDA consider using in the future for REMS?
  • What should the process of standardization look like?
  • What would make written educational materials more effective for patients?
  • Could the provision of patient information be made easier? What About the counseling process?

A Coming Guidance

The outcome of the meeting will be a report regarding the agency's findings, including projects to be completed in four priority areas: pharmacy systems, prescriber education, providing benefit/risk information to patients, and practice settings. In addition, FDA said it would begin work on a methodologies guidance document regarding the assessment of REMS products and whether an ETASU is appropriate for purpose and not "unduly burdensome" on patients.

Read the meeting announcement here.

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