Pill politics : drugs and the FDA / Stephen J. Ceccoli.

Format:

Book

Author/Creator:

Ceccoli, Stephen J., 1968- author.

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Pharmaceutical policy--United States.

Pharmaceutical policy.

Physical Description:

1 online resource (223 p.)

Place of Publication:

Boulder, Colorado ; London, [England] : Lynne Rienner Publishers, 2004.

Summary:

From aspirin to Viagra to the latest cancer treatment, the Food and Drug Administration acts as a gatekeeper determining what medicines are legally available in the United States. But in fulfilling that regulatory role, Stephen Ceccoli argues, the FDA may inadvertently be promoting new drugs at the expense of public health.The FDA's initial mandate to protect health grew out of pharmaceutical-related disasters in the early 1900s. Later criticisms that the agency's approach impeded industry competitiveness and failed to meet public need, however, led to a political compromise on its mission. The new FDA has cut its review time nearly in half and allows direct-to-consumer advertising, off-label promotion of drugs, and the "fast-tracking" of treatments. Ceccoli convincingly shows that this approval process, while redressing valid complaints, is also creating a new complex of problems that must be resolved.

Contents:

Frontmatter

Contents

Tables and Figures

Acknowledgments

1. Putting the FDA into Perspective

2. The Politics of Assessing Drugs

3. An Evolving Regulatory Balance

4. The Drug Lag Debate and Demands for Reform

5. A Grand Compromise and the Shift to a New Era

6. Whither the FDA?

7. Protecting and Promoting Public Health in the United States

Appendix: Drug Development and the FDA’s Approval Process

List of Abbreviations

Notes

Bibliography

Index

About the Book

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

1-62637-410-4