The New Medicines

How Drugs are Created, Approved, Marketed, and Sold

Bernice Z. Schacter

• Publisher: Praeger
• Year: 2005
• Print ISBN:
  9780275981419
• Edition: 1
• eBook ISBN:
  9780313083259
• Topic: Biological Sciences
• Subtopic: Science General
• Index: Biological Sciences

Today, most people use prescription medications. Every year, the multi-billion dollar pharmaceutical industry produces new medicines that treat everything from arthritis to AIDS, from high cholesterol to depression. But, despite recent controversies regarding the safety of drugs, consumers know little about the medications that they ingest and inject. How are these new medicines invented? How do consumers know that drugs are safe and effective? How are they tested? Who regulates their production - and who watches the regulators? How do drug companies produce the vast quantities needed for the marketplace, and why do they market their drugs as they do? The New Medicines leads the reader through the maze of the modern drug industry - from bench to bedside - and provides consumers with a step-by-step understanding of how new medicines are created, approved, marketed, and sold.

In addition to explaining how drugs reach the medicine cabinet, the author - an experienced researcher and teacher - provides the scientific and business background for understanding the current controversial issues surrounding new medicines, such as: The rise and fall of the COX-2 inhibitors, Vioxx and Celebrex, and the process by which they were invented, approved, and re-evaluated. The saga of the cancer drug Erbitux and its creator, the company Imclone, made famous as the centerpiece of the Martha Stewart insider-trading scandal. The strengths and weaknesses of the approval process of the Food and Drug Administration. The controversial new marketing techniques of the pharmaceutical industry. A balanced work that provides readers with an unbiased look at the drug industry, The New Medicines will answer the questions of anyone who has ever looked at a bottle of their prescription pills and wondered, how did that get here?

Table of contents

• Contents
• Preface
• Abbreviations and Acronyms
• 1 The Path from Bench to Bedside
• 2 How Did the FDA Get to Be in Charge? The History of Regulation of Human Drugs
• 3 The Eureka Moment: How New Medicines Are Discovered
• 4 Test Tube Results Are Not Enough: Animal Tests for a Drug’s Utility
• 5 The Business Decisions: Committing to Development
• 6 Production of the New Drug
• 7 Laboratory and Animal Safety Testing
• 8 Getting Set for Clinical Trials
• 9 Phase 1 Clinical Trials
• 10 Phase 2 Clinical Testing
• 11 Phase 3 Testing
• 12 Putting Together the Application for Approval: The New Drug Application (NDA)
• 13 Everybody Holds Their Breath: Will the FDA File the NDA?
• 14 The FDA Review
• 15 What Do Outside Experts Think? The Advisory Committee Meeting and FDA Approval
• 16 The Launch: Marketing the Drug
• 17 It's Not Over Till It’s Over: Post-Approval Studies
• 18 Are We (Well) Served? Do We Have the System, Industry, and Regulations We Need, Want, and Deserve?
• Bibliography
• Index