Erythropoiesis-Stimulating Agents Technical Advisory Committee Meetings

Medical Technology And Practice Patterns, Bethesda MD

Investigators

Abstract

Erythropoiesis-Stimulating Agents (ESAs) Technical Advisory Committee Meetings This proposal addresses FDA concerns regarding use of ESAs. Over the course of the next three years, we propose to hold one TAC meeting per year to address the following topics: i. Topic #1 - Progress on Patients'Anemia Knowledge in Kidney Disease (PAKKD) is consistent with FDA's Safe Use Initiative interests in working with partners--patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, and other Federal agencies--to select specific candidate cases of preventable, drug-related harm for analysis, intervention proposals, and evaluation metrics. ii. Topic #2 - Study proposal to test lower hematocrit target for epoetin therapy for diabetic patients is consistent with FDA's post-marketing surveillance of drug adverse effects. Because all possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to several thousand patients, FDA is interested in post-marketing surveillance and risk assessment to identify adverse events that did not appear during the drug approval process. This information could be useful in updating drug labeling and possibly, to reevaluate the approval or marketing decision. iii. Topic #3 - Using claims data to identify practice pattern variation is consistent with FDA's interest in using electronic health record (EHR) data for post-market risk detection and to identify opportunities for public-private collaborations for building the data collection and risk identification and analysis components of the network