FDA Solicits Input on Developing REMS for Drugs and Biologics, Extends Comment Periods

July 22, 2010 2:35 pm

Food and Drug Administration (FDA) continues to seek input on the developing risk evaluation and mitigation strategies (REMS) for drugs and biologics through both public participation in an upcoming meeting and written comments. FDA seeks comments from various stakeholders, many of whom have raised concerns about the impact of various REMS, and the growing number of REMS on the health care system, and on individual prescribers, pharmacists, distributors, and other affected stakeholders. FDA makes note of some of the concerns raised regarding the impact on pharmacists and pharmacy workflow in the Federal Register notice. Further, the agency is seeking public comment on six specific areas and includes a list of questions for each area in the notice.

The public meeting will take place July 27-28, 2010, and FDA requires preregistration for individuals wishing to present. A live Web cast of the meeting will be available on the day of the meeting on the FDA Web site at www.fda.gov/Drugs/NewsEvents/ucm210201.htm.

The comment period for the draft guidance for industry on ‘‘Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications’’ has been reopened until August 31, 2010. Instructions for submitting comments are included in the June 17, 2010 Federal Register notice.

In addition, the period for written comments on REMS for certain opioid drugs has been extended, and written or electronic comments will be accepted until October 19, 2010, following the instructions in the October 19, 2009 Federal Register.