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Volume 353:1197-1199 September 22, 2005 Number 12 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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The Food and Drug Administration (FDA) has again postponed issuing a decision about making emergency contraception available to women without a prescription. This decision — or nondecision — deserves serious scrutiny, since it appears to reflect political meddling in the drug-approval process.

Emergency contraception in the form of Plan B has been available by prescription in the United States since 1999, but its manufacturer, Barr Laboratories, has proposed that it be sold over the counter. Plan B consists of two 0.75-mg levonorgestrel tablets to be taken 12 hours apart as soon as possible, and within 72 hours, after an act . . . [Full Text of this Article]

Source Information

Dr. Wood is a professor of medicine and pharmacology at Vanderbilt University School of Medicine, Nashville, and was a member of the FDA Advisory Committee on Nonprescription Drugs; Dr. Drazen is the editor-in-chief of the Journal; and Dr. Greene is an associate editor of the Journal and was a member of the FDA Advisory Committee on Reproductive Health Drugs.

Related Letters:

A Sad Day for Science at the FDA
Burstein P. D., Fernández J. V., Grant E. C., Greene M. F., Drazen J. M., Wood A. J.J.
Extract | Full Text | PDF  
N Engl J Med 2005; 353:2619-2621, Dec 15, 2005. Correspondence

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• Ray, W. A., Stein, C. M. (2006). Reform of Drug Regulation -- Beyond an Independent Drug-Safety Board. NEJM 354: 194-201 [Full Text]  
• Burstein, P. D., Fernandez, J. V., Grant, E. C., Greene, M. F., Drazen, J. M., Wood, A. J.J. (2005). A Sad Day for Science at the FDA. NEJM 353: 2619-2621 [Full Text]  
• Markel, H. (2005). Why America Needs a Strong FDA. JAMA 294: 2489-2491 [Full Text]  
• Wood, S. F. (2005). Women's health and the FDA.. NEJM 353: 1650-1651 [Full Text]  
• Tanne, J. H. (2005). FDA official resigns over emergency contraception decision. BMJ 331: 532-532 [Full Text]