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April 25, 2001

Isotretinoin and Pregnancy—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;285(16):2079-2081. doi:10.1001/jama.285.16.2079

In Reply: The PPP was first developed in 1988 to assist physicians in complying with the requirements of the package insert. The program consists of a system to inform patients about the risks and benefits of isotretinoin and to evaluate a patient's ability to comply with the requirement to not be or become pregnant during the course of therapy. In addition, it provides tools for the prescriber to obtain informed consent and educational material, which would reinforce the prescriber's instructions.

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