Suchergebnisse

Since the vast majority of prescription drugs consumed by Americans are off patent ('generic'), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I's FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II's implementation among other outcomes. ; Published version

The advent of novel psychotropic medications has revolutionized treatments for mental illnesses over the past few decades. Concurrently, changes in mental health coverage, particularly for Medicaid patients, created economic incentives for insurance carriers to shift costs and to encourage the use of psychotropic drugs. To quantify these effects, based on the framework in Griliches' seminal study on hybrid corn, we estimate logistic diffusion models using a longitudinal data set on Medicaid drug utilization. We find that financial incentives played a significant role in encouraging use of new medications that have lower physician specialty skill requirements. (JEL O30, O33, I18, L14)

This volume contains papers presented at a conference in May 1988 in Washington, D.C., commemorating the fiftieth anniversary of the founding of the Conference on Research in Income and Wealth (CRIW). The call for papers emphasized assessments of broad topics in economic measurement, both conceptual and pragmatic. The organizers desired (and succeeded in obtaining) a mix of papers that, first, illustrate the range of measurement issues that economics as a science must confront and, second, mark major milestones of CRIW accomplishment. The papers concern prices and output (Griliches, Pieper, Triplett) and also the major productive inputs, capital (Hulten) and labor (Hamermesh). Measures of saving, the source of capital accumulation, are covered in one paper (Boskin); measuring productivity, the source of much of the growth in per capita income, is reviewed in another (Jorgenson). The use of economic data in economic policy analysis and in regulation are illustrated in a review of measures of tax burden (Atrostic and Nunns) and in an analysis of the data needed for environmental regulation (Russell and Smith); the adequacy of data for policy analysis is evaluated in a roundtable discussion (chapter 12) involving four distinguished policy analysts with extensive government experience in Washington and Ottawa

Intro -- Contents -- Prefatory Note -- Introduction - Ana Aizcorbe, Colin Baker, Ernst R. Berndt, and David M. Cutler -- I. Methodological Issues in Measuring Health Care Costs and Outcomes -- 1. Measuring Health Services in the National Accounts: An International Perspective - Paul Schreyer and Matilde Mas -- Comment: J. Steven Landefeld -- 2. A Cautionary Tale in Comparative Effectiveness Research: Pitfalls and Perils of Observational Data Analysis - Armando Franco, Dana P. Goldman, Adam Leive, and Daniel McFadden -- 3. Decomposing Medical Care Expenditure Growth - Abe Dunn, Eli Liebman, and Adam Hale Shapiro -- 4. Calculating Disease- Based Medical Care Expenditure Indexes for Medicare Beneficiaries: A Comparison of Method and Data Choices - Anne E. Hall and Tina Highfill -- II. Analyses of Subpopulations and Market Segments -- 5. Measuring Output and Productivity in Private Hospitals - Brian Chansky, Corby Garner, and Ronjoy Raichoudhary -- 6. Attribution of Health Care Costs to Diseases: Does the Method Matter? - Allison B. Rosen, Ana Aizcorbe, Tina Highfi ll, Michael E. Chernew, Eli Liebman, Kaushik Ghosh, and David M. Cutler -- 7. The Simultaneous Effects of Obesity, Insurance Choice, and Medical Visit Choice on Health Care Costs - Ralph Bradley and Colin Baker -- III. Prescription Pharmaceutical Markets -- 8. The Regulation of Prescription Drug Competition and Market Responses: Patterns in Prices and Sales following Loss of Exclusivity - Murray L. Aitken, Ernst R. Berndt, Barry Bosworth, Iain M. Cockburn, Richard Frank, Michael Kleinrock, and Bradley T. Shapiro -- 9. Specialty Drug Prices and Utilization after Loss of US Patent Exclusivity, 2001–2007 - Rena M. Conti and Ernst R. Berndt -- 10. Drug Shortages, Pricing, and Regulatory Activity - Christopher Stomberg -- IV. Issues in Industrial Organization and Market Design

Annotation With the United States and other developed nations spending as much as 14 percent of their GDP on medical care, economists and policy analysts are asking what these countries are getting in return. Yet it remains frustrating and difficult to measure the productivity of the medical care service industries. This volume takes aim at that problem, while taking stock of where we are in our attempts to solve it. Much of this analysis focuses on the capacity to measure the value of technological change and other health care innovations. A key finding suggests that growth in health care spending has coincided with an increase in products and services that together reduce mortality rates and promote additional health gains. Concerns over the apparent increase in unit prices of medical care may thus understate positive impacts on consumer welfare. When appropriately adjusted for such quality improvements, health care prices may actually have fallen. Provocative and compelling, this volume not only clarifies one of the more nebulous issues in health care analysis, but in so doing addresses an area of pressing public policy concern.