BMJ 2004;329:182-183 (24 July), doi:10.1136/bmj.329.7459.182
Editorial
Which drugs should be available over the counter?
The criteria are clear and include safety, timeliness, and opportunity cost
| The first 150 words of the full text of this article appear below. |
As contraception after intercourse, levonorgestrel is available by prescription in the United States and in most other countries. In over 30 countries it is available without prescription.1 Levonorgestrel recently came to wide attention when the US Food and Drug Administration (FDA) acted on an application to switch the drug to non-prescription or "over the counter" status.2 The application was supported by essentially all internal scientific staff and the external advisory committee of the FDA, but the FDA rejected the application. The reason given had to do with the ability of women to understand the appropriate use of the product,3 but this issue had been explicitly discussed and settled to the satisfaction of the FDA's scientists and external advisory committee4 The FDA's explicit denial that the decision had been the result of political pressure has been received with scepticism.5-8
How should policy makers decide which drugs should be available over . . . [Full text of this article]
Robert R Fenichel, consultant
3922 Ingomar Street, NW, Washington DC 20015-1916 USA (bob@fenichel.net)

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