HHS OIG Report: FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies (REMS) Improve Drug Safety

The Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) released a report, which asserts that the Food and Drug Administration (FDA) is not receiving crucial information from pharmaceutical manufactures regarding Risk Evaluation and Mitigation Strategies (REMS).  OIG also released a podcast explaining the report.  The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Food and Drug Administration Amendments Act of 2007 and the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), authorizes FDA to require REMS for certain drugs and biological products to assure that their benefits outweigh their risks.  REMS are structured plans to manage specific risks of drugs that are effective but associated with known or potential risks (e.g., death, injury) that, without REMS, may outweigh benefits.   When FDA requires a REMS, the drug manufacturer (i.e., sponsor) must develop, implement, and assess it.  FDA reviews and approves each REMS.  FDA has the authority to, among other things, deem a drug misbranded or impose civil monetary penalties on sponsors that violate approved REMS.  However, FDA does not have the authority to take enforcement actions against sponsors that do not include all information requested in FDA assessment plans.  If FDA does not have comprehensive data to monitor the performance of REMS, it cannot ensure that the public is provided maximum protection from a drug’s known or potent...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs