NCPA Comments to FDA re REMS Reopening of Comment Period FINAL 8.31.10

VIA Electronic Submission to http://www.regulations.gov August 31, 2010 Division of Dockets Management (HFA–305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period [Docket Nos. FDA–2010–N–0284 and FDA–2009–D–0461] Dear Sir or Madam: Thank you for the opportunity to submit our comments related to issues and challenges associated with the development and implementation of REMS. As the Food and Drug Administration (FDA) considers issues pertinent to REMS, the National Community Pharmacists Association (NCPA) appreciates the opportunity to share the perspectives of independent community pharmacists. NCPA represents America’s community pharmacists, including the owners of more than 22,700 independent community pharmacies, pharmacy franchises, and chains. Together they represent an $88 billion health care marketplace, employ over 65,000 pharmacists, and dispense over 40% of all retail prescriptions. NCPA is pleased to have presented the views of independent community pharmacists at the FDA’s 2-day public REMS meeting, held July 27-28, 2010. The comments below reflect our statements at that meeting and address specific questions and points of clarification posed by FDA staff during the panel discussions. We applaud the FDA for making the process that led to the July public meeting and reopening of the ...