The process for drug approval in the United States is complex and time-consuming. There are comparatively few drugs with U.S. Food and Drug Administration (FDA)-approved indications for obstetric use in this country at this time; however, several are under development. We review the process for drug approval and recount the approval histories of obstetric drugs reviewed in the recent past. We also outline the current status of two progestational agents that are under development. For a variety of reasons, including a small market compared with others such as cardiology or oncology, and the potential of being drawn into medical–legal litigation, sponsors are disinclined to pursue drug development for obstetric purposes in this country. We compare the procedures for review and approval of drugs in the United States with those in Europe, and note that recent changes within the FDA may result in not only more drugs being approved but also changes in labeling of already approved drugs. Special programs to facilitate drug development and reforms to modernize the process and improve safety are discussed. These may result in changes in labeling of already approved drugs. Obstacles such as funding and liability are also discussed.
This report outlines the process and the history behind several drugs that have undergone or are undergoing review for U.S. Food and Drug Administration approval for use in obstetrics.
From the University of California, Irvine, Orange, California; Cytokine Pharmasciences, King of Prussia, Pennsylvania; and ProteoGenix, Inc., Costa Mesa, California.
Corresponding author: Deborah A. Wing, MD, Department of Obstetrics-Gynecology, University of California, Irvine, 101 The City Drive South, Building 56, Suite 800, Orange, CA 92868; e-mail: firstname.lastname@example.org.
Financial Disclosure Dr. Wing served as a consultant for the U.S. Food and Drug Administration, Center for Devices and Radiological Health, Medical Devices Advisory Committee, Obstetrics and Gynecology Devices Panel, 2003–present; was speaker and section leader in November 2008 for the U.S. Food and Drug Administration, Division of Radiologic Devices (a per diem reimbursement plus additional reimbursement for travel expenses was received for this activity); served as a paid consultant for Cytokine PharmaSciences, Inc., developer of Misopess, the misoprostol vaginal insert; acts as private investigator for this sponsor and has been involved in the conduct of two phase II and one phase I trial for them; and had travel paid for by Cytokine PharmaSciences, Inc., to attend a meeting with representatives of the U.S. Food and Drug Administration on Misopess. Dr. Powers is an employee of Cytokine PharmaSciences, Inc., parent company of Controlled Therapeutics, Ltd. (Scotland), the sponsor of the misoprostol vaginal insert. Dr. Hickok previously received payments from Hologic, Inc., as part of Hologic's acquisition of Cytyc, which previously had acquired Adeza Biomedical Corporation.