Erythropoiesis-Stimulating Agents (ESAs) Technical Advisory Committee MeetingsThis proposal addresses FDA concerns regarding use of ESAs. Over the course of the next three years, we proposeto 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'sSafe 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 specificcandidate 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 isconsistent with FDA's post-marketing surveillance of drug adverse effects. Because all possible side effects of adrug 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 appearduring the drug approval process. This information could be useful in updating drug labeling and possibly, toreevaluate the approval or marketing decision.iii. Topic #3 - Using claims data to identify practice pattern variation is consistent with FDA's interest in usingelectronic health record (EHR) data for post-market risk detection and to identify opportunities for public-privatecollaborations for building the data collection and risk identification and analysis components of the network

Public Health Relevance

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 topics listed below. These topics are consistent with the following general interests of FDA: * Discovery of new knowledge relevant to the post market approval drug experience (patterns of drug use and safety); * Ensuring that marketed drugs are safe and clinically effective and that their risk: benefit profile remains acceptable during the market life of a drug; * Evaluating the of effectiveness of regulatory actions, patterns of drug use, including off-label, signal detection methodologies (e.g., data mining techniques), epidemiologic studies of therapeutics using population- based data, and * Developing and evaluating of the effectiveness of new methods and tools for managing the known risks of marketed drug products (e.g., communicating newly identified risks to health care practitioners and patients). In addition, Healthy People furthermore recommends that ESRD complications, disability, death, and economic costs be reduced substantially by 20101 (1). According to KDOQI, the evidence base for use of epoetin requires information generated from anemia management protocols that examine multiple interventions and explicitly state underlying goals and assumptions2 (2). In its effort to cover all drugs, the Medicare Modernization Act calls for identification of 'strategies for improving the efficiency and effectiveness of'...therapies used 3(3). A better understanding of the relationship between epoetin dosing strategies and survival will contribute towards improved treatment guidelines, and improved survival of ESRD patients. We propose 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 1.U.S. Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd ed. Washington, DC: U.S. Government Printing Office, November 2000. 2.K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification PART 7. Stratification of Risk for Progression of Kidney Disease and Development of Cardiovascular Disease Guideline 15. Association of Chronic Kidney Disease with Cardiovascular Disease. 3.Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Public Law 108-173 108th Congress, SEC. 1013. Research on Outcomes of Health Care Items and Services

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Conference (R13)
Project #
1R13FD003900-01
Application #
8017794
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2010-05-01
Project End
2011-04-30
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
1
Fiscal Year
2010
Total Cost
Indirect Cost
Name
Medical Technology and Practice Patterns
Department
Type
DUNS #
612993097
City
Bethesda
State
MD
Country
United States
Zip Code
20816