MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports
The US Food and Drug Administration (FDA) last month offered a new Manual of Policies and Procedures (MAPP) to explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports submitted to the agency.Although the statute does not specifically describe how companies should conduct their assessments, the agency has released two draft guidances (one on survey methodologies and another on planning and reporting REMS assessments, both from last January) and now, this new MAPP, effective 18 December 2019, for further explanation.
Background
FDA can require a REMS for certain drugs if it determines that one is necessary to ensure that the benefits of the drug outweigh its risks. A REMS may include a medication guide, a patient package insert, a communication plan and/or packaging and disposal requirements. FDA also may require certain elements to assure safe use (ETASU) as part of a REMS.
FDA finalized guidance in May on when a REMS is necessary.
In addition, a proposed REMS must have a timetable for the submission of assessments by sponsors, which includes assessments submitted to FDA by either 18 months or three years after the strategy is initially approved, and in the seventh year after the strategy is approved, or at some other frequency specified in the REMS, which FDA says can be increased or reduced in frequency under certain circumstances or even eliminated.
In addition to the required assessments, an applicant may voluntarily submit an assessment of an approved REMS at any time.
Procedures
As far as the work on FDA’s end, the REMS assessment reviews are conducted by the Office of Surveillance and Epidemiology’s Division of Risk Management. The office issues the appropriate REMS assessment letter, except in certain circumstances, no later than 180 calendar days from receipt of the REMS assessment report submission.
The review by FDA’s REMS assessment analyst involves deciding if the submission requires the sponsor to provide additional information (with language assessed and approved by team leaders) to complete the review, deciding whether a consultation with other FDA staff on the review is necessary, and then drafting a REMS assessment review and meeting slides, which incorporates key report findings, preliminary conclusions received from the consulted offices, and recommendations for discussion at REMS Assessment Review Team meetings.
The MAPP also discusses in detail the various levels of FDA offices and divisions that have to review and approve the assessment reviews.
MAPP
Approved REMS