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# Improve Evaluation of REMS Programs: Study
- URL: https://www.fdaweb.com/improve-evaluation-of-rems-programs-study/
- Published: 2026-11-05T22:30:00.000Z
- Updated: 2026-11-06T02:53:41.000Z
- Author: David McFarland
- Tags: Drugs

Yale School of Medicine researchers say there are steps FDA could take to improve the evaluation of elements in Risk Evaluation and Mitigation Strategies (REMS) programs. Writing in *JAMA Internal Medicine*, the [researchers say](https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2855592?resultClick=1&ref=fdaweb.com) REMS requirements intended to increase patient and prescriber knowledge of medication safety and risks include medication guides, communication plans, and elements to assure safe use, such as the patient agreement form for mifepristone.

However, they say, according to the data made available by the agency, assessments of the efficacy of these measures in achieving their stated goals are conducted by drug manufacturers, primarily consisting of administered cross-sectional surveys.

They say such surveys do little to evaluate whether the elements of the REMS improve knowledge or change behavior, with their lack of pre-post testing, reliance on convenience sampling, and lack of adequate controls. Indeed, they write, the first recommendation from a 2013 Office of Inspector General report specifically states, “FDA should decrease its reliance on survey data in sponsors’ assessments.”

The article cites a study of the mifepristone patient agreement and says it likely provides “the first rigorous evaluation of these REMS components with enough information to draw reasonable conclusions as to their efficacy.”

The authors conclude that FDA has several options to ensure robust evaluation of REMS programs. Although sponsors are legally required to conduct assessments of REMS programs, they say, FDA could mandate improvements in data collection and design of the assessments to yield better evidence of the efficacy of REMS components.8 Also, although FDA relies on sponsors to conduct the assessments, that does not preclude the agency from conducting its own evaluations or partnering with other institutions to design and conduct more rigorous evaluations, including trials.

“Situating such assessments within the agency or with independent researchers may also yield greater trust in FDA as they use these findings for potential modifications to the REMS program,” the researchers report. “Underpinning these improvements is a need for both increased transparency in FDA REMS evaluations and continued shielding of REMS decision-making from political influence. As we have called on before, the agency must do more to live up to its principles of ‘radical transparency’ and ‘gold-standard science.’ Developing and publishing evaluation plans, data, and the agency’s rationale for how that data were considered in making regulatory decisions for each REMS will allow the scientific community to both independently evaluate its work and engage in dialog with FDA as a key component of ‘gold-standard science.’”