FDA Looking to Develop Further REMS Guidance, Release Issue Paper

Posted 02 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is planning a workshop to gather feedback and information it can use to develop guidance for industry on the best practices for assessing goals associated with Risk Evaluation and Mitigation Strategy plans.

The workshop, announced in a 2 May Federal Register posting, will take place on 7 June 2012.

"The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients' and health care providers' knowledge about the risks of drugs marketed with an approved REMS," wrote FDA in the Federal Register posting.

To further this discussion, FDA announced it will release an issue paper that will discuss FDA's "experience with knowledge assessments for REMS and contains specific questions we hope to receive input on."

While that paper is as-yet unreleased, it is expected to be released 3 May on FDA's website.

FDA notes in its guidance that REMS plans were authorized under the FDA Amendments Act of 2007, and are typically for new drug products. However, if FDA is made aware of new safety concerns with an existing drug, it may require a REMS plan to be developed for that product as well.

REMS plans can include Medication Guides, communication plans, elements to assure safe use (ETASU) and an implementation system, depending on the safety profile of the drug.

These REMS aspects are intended to educate the patients and prescribing physicians on the safe use of the product, and industry is expected to prove to FDA that its REMS plans are effective.

FDA's meeting intends to focus on evaluating the effectiveness of those REMS plans in light of "certain challenges to conducting these types of studies" that FDA has identified.

These challenges include study methodologies, appropriate sample size, representative samples, appropriate endpoints, survey design and the presentation of results gathered by industry.

While FDA notes "absolute uniformity is not possible," it intends to "introduce and sustain some measure of consistency in methods and expectations," some of which might be reflected in guidance released after the meeting.

Read more:

FDA- Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge; Public Workshop; Issue Paper

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