Pharmaceutical Public Policy

Thomas R. Fulda, Alan Lyles, Albert I Wertheimer



As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn’t always work well.

Pharmaceutical Public Policy provides the understanding and framework required for effective organization, financing, and delivery of pharmaceutical products and services. It supplies an overview of the policy process as well as the roles of legislation and regulation in pharmaceutical policy.

The book identifies the goals, objectives, and key policy issues of concern to stakeholders involved in the development of products, use of pharmaceuticals in healthcare, and administration of insurance programs by both the private and government sectors. Policy issues examined include the appropriateness of prescribing and patient adherence.

Addressing questions of access, quality, and cost, the book considers the operation of the Affordable Care Act and Medicare Part D. It details the responsibilities of Federal providers of pharmaceutical care and private and public payers such as managed care organizations, pharmacy benefit managers, Medicare, and Medicaid.

The book covers the policies and practices involved in promoting pharmaceutical products. It also considers pharmacoeconomics as a response to market failure. Finally, the book describes the market, the role of the manufacturer, drug shortages, and the responsibilities of the FDA.

The book includes a Foreword by Jerry Avorn, MD, Professor of Medicine, Harvard Medical School; and Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Woman’s Hospital.

Table of Contents

Policy Process

Federal Legislative Process

Role of Federal Regulations and How They Are Developed

Access, Quality, and Cost

Why Is Medication Use Less than Appropriate?

Medication Adherence and Health Policy

Good Governance and Corruption in the Pharmaceutical System

U.S. Food and Drug Administration

Risk Minimization: A New Regulatory Challenge Directive

Drug Shortages

Drug Reimportation into the United States

Competition between Brand-Name and Generic Drugs

Structure and Dynamics of the Pharmaceutical Industry

Health Policy and Economic Issues in Biotechnology and Personalized Medicine

Pharmaceutical Promotion in the United States

Health Technology Assessment

Pharmacoeconomics as a Response to Market Failure: An International Perspective

Market for Pharmaceuticals

Managed Care Pharmacy and Pharmacy Benefit Management

Drug Insurance Design and Management

Electronic Information Technology: Role in Supporting Drug Use and Policy

Assessing Medicare Part D after 10 Years

Medicaid

Medication Therapy Management Services

The Affordable Care Act: Potential Impacts on Pharmaceutical Markets

Role of Government as Regulator, Payer, and Provider of Care

Department of Veterans Affairs Pharmacy Programs

Public Health Service

Index