The development of mifepristone: a pharmaceutical drama in three acts.
This paper reviews the various steps in development of mifepristone in Europe and in the United States. It is a personal account by the person who was in charge of its worldwide development and has participated in all the major decisions on the product. This paper presents a personal perspective on the development of mifepristone, explaining why this revolutionary medication is still not available in most of the world, including the United States. Briefly, the author's close and continuous involvement with the medical, regulatory, and commercial aspects of mifepristone development for more than 15 years provides a unique insider's view. The development of mifepristone has been so fraught with drama that I present it here as a theatrical piece. Nonetheless, the story has been told as objectively as possible.
Ulmann
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Laboratoire HRA Pharma, Paris.
D000021:Abortifacient Agents, Steroidal / Q000494:pharmacology / Q000627:therapeutic use; D000028:Abortion, Induced; D017277:Drug Approval; D015195:Drug Design; D004345:Drug Industry; D005060:Europe; D007880:Legislation, Drug; D015735:Mifepristone / Q000494:pharmacology / Q000627:therapeutic use; D012924:Social Conditions; D014481:United States
D000021:Abortifacient Agents, Steroidal; D015735:Mifepristone