Drugs

PDUFA Post-market Group Focuses on REMS Assessments

An FDA/industry Prescription Drug User Fee Act reauthorization subgroup met recently to discuss the agency’s plans on risk evaluation and mitigation strategies (REMS) assessment modernization under the next user fee program that starts in late 2022, according to a summary of the meeting. FDA says its REMS proposals focus on improving design planning, clarifying expectations, improving review efficiencies, and improving transparency.

Last year, FDA issued two draft guidances to help improve the agency’s ability to ensure that risk mitigation programs for certain drugs and biologics as a requirement of their approval are working. The first guidance, REMS Assessment: Planning and Reporting, describes how to develop a REMS assessment plan, specifically how the REMS program goals, objectives, and REMS design may affect the selection of metrics and data sources, which will be used to assess whether the program is meeting its risk mitigation goals. The document also discusses considerations for assessing the impact of REMS on patient access to the drug and its burden to the healthcare delivery system. Finally, it provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.

The second guidance, Survey Methodologies to Assess REMS Goals That Relate to Knowledge, gives information to industry on conducting REMS assessment surveys, used to evaluate respondent knowledge of REMS-related information. The document discusses general principles and recommendations relating to conducting REMS assessment surveys, including study design, survey instrument development, survey data collection and processing, and data analysis.

In reaction to the guidances, several stakeholders urged FDA to make changes to its plans. The International Society for Pharmacoepidemiology encouraged FDA to use the guidance to enhance transparency and further the regulatory science in this area by making the results of REMS assessment reports, redacted of proprietary information, or at least the key conclusions from FDA’s assessments, available to the public through the agency REMS Web site. The Biotechnology Innovation Organization said it is not clear from the draft guidance how existing/well-established REMS will be addressed. BIO encouraged FDA to clarify that existing REMS would be grandfathered, particularly regarding evaluation of burden on the healthcare system and patient access.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome