Gaps, Tensions, and Conflicts in the FDA Approval Process:

Conclusion

Despite derogatory comments from some politicians and some in the industries it regulates, the FDA does a credible job of trying to protect the public and to quickly review new drugs and devices. However, pressures for speed, conflicts of interest in decision-making, constrained legislative mandates, inadequate budgets, and often limited surveillance after products enter the market mean that scientific considerations are only part of the regulatory equation. These limitations can lead to misleading advertising of new drugs; promotion of less effective over more effective treatments; delays in identifying treatment risks; and perhaps unnecessary exposure of patients to treatments whose risks outweigh their benefits.

Regulatory approval provides many critical functions. However, it does not in itself help clinicians to identify the best treatment strategies. Physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time they are marketed; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in the approval process. If clinicians are to practice evidence-based and cost-effective medicine, they must use additional skills and resources to evaluate new treatments. Depending exclusively on the regulatory process may lead to suboptimal care.

Acknowledgments

Dr. Larry Kessler was generous with his time in providing an interview, several discussions, and review of the manuscript. Dr. Sean Sullivan also provided a helpful review of the manuscript.

Funding information

This work was supported by a Robert Wood Johnson Foundation Investigator Award in Health Policy Research.

Reprint Address

Address correspondence to Richard A. Deyo, Department of Medicine, Box 356429, University of Washington, Seattle, WA 98195 (e-mail: deyo@u.washington.edu).

The views and conclusions expressed are those of the author and do not necessarily represent those of or imply endorsement from the Food and Drug Administration, the US government, or the Robert Wood Johnson Foundation.

Cite this: Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice - Medscape - Mar 01, 2004.