Inactive

The FDA's Office of Surveillance and Epidemiology (OSE) requires access to inpatient hospital drug utilization data in order to evaluate drug risks and promote the safe use of drugs by the American pe... The FDA's Office of Surveillance and Epidemiology (OSE) requires access to inpatient hospital drug utilization data in order to evaluate drug risks and promote the safe use of drugs by the American people. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. The ability of FDA to respond expeditiously to the increasing number of drug safety issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthens the utility of the passive reporting system currently in place by providing estimates of the numbers of adult and pediatric patients exposed to drugs nationwide in the hospital setting. These data resources provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the hospital setting. Access to these data also increase the FDA’s ability to request regulatory impact studies such as those authorized under Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) to better understand the usefulness of drug labeling to clinicians. This can be done by examining actual use of products in hospitals in relation to recommended labeling. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process. To strengthen the Drug Utilization Program, the Food and Drug Administration (FDA) requires continual direct access to commercially available hospital drug utilization data and regulatory drug utilization services. Please see the attached solicitation for full requirement details and proposal submission instructions. The purpose of Amendment 1 is to provide responses to the solicitation questions recieved. Please see the attached amendment.