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FDA's iPledge Program to Begin March 1


Despite objections from dermatologists, the U.S. Food and Drug Administration will stick to March 1 as the start date for iPledge, a program designed to prevent birth defects caused by an acne drug.

The iPledge goal is to register women of childbearing age who use the drug Accutane and its generic versions and to require them to have pregnancy tests before getting a prescription for the drugs.

Text Continues Below



Dermatologists argue that the program to prevent pregnant women from using the drug may keep the drug away from patients who need it to treat severe acne, the Associated Press reported.

The FDA already delayed implementation of iPledge, which had been scheduled to take effect last November.

Some critics charge that the program is too complex and may prevent patients from getting drugs to treat forms of acne that can cause serious scarring, the AP reported.

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Copyright © 2006 ScoutNews LLC. All rights reserved.
Last updated 2/22/2006





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