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Previous Volume 354:194-201 January 12, 2006 Number 2 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Recent withdrawals from the market of high-profile drugs have led to a reexamination of the process of drug regulation and have stimulated concern that the current process is inadequate for protection of the public health.^1,2 The perceived inability of the Food and Drug Administration (FDA) and the pharmaceutical industry to evaluate drugs impartially and to respond adequately to signals indicating potential drug-safety problems has created extensive support for the establishment of an independent drug-safety board.³ However, because the limitations of the current process go well beyond these conflicts of interest, we propose more extensive reforms designed to protect the public . . . [Full Text of this Article]

Limitations of the Present Regulatory System

A Reformed Regulatory Process

Controversial Elements of the Proposed Reforms

Relative-Efficacy Studies

Phased Release of New Drugs

Independent Conduct of Post-Marketing Studies

Communication of Drug Information

Conclusions

Source Information

From the Center for Education and Research on Therapeutics (W.A.R., C.M.S.); the Geriatric Research, Education and Clinical Center, Veterans Affairs Medical Center (W.A.R.); and the Departments of Medicine and Pharmacology, Divisions of Rheumatology and Clinical Pharmacology (C.M.S.), Vanderbilt University School of Medicine — all in Nashville.

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