Challenges to the FDA Approval of Mifepristone

American Association of Pro Life Obstetricians and Gynecologists, Christian Medical Association and Concerned Women for America. Citizen petition re: request for stay and repeal of the approval of Mifeprex (mifepristone) for the medical termination of intrauterine pregnancy through 49 days' gestation. Filed with the FDA August 2002. www.cwfa.org/ru486/Citizen%20Petition_Mifeprex%208.20.02.pdf (accessed 2003 Sept 21).

Laue L Lotze MT Chrousos GP Barnes K Loriaux DL Fleisher TA. Effect of chronic treatment with the glucocorticoid antagonist RU 486 in man: Toxicity, immunological, and hormonal aspects. J Clin Endocrinol Metab 1990;71:1474–80.

Spitz IM Bardin CW. Clinical pharmacology of RU 486-an antipro-gestin and antiglucocorticoid. Contraception 1993;48:403–44.

Shi WL Wang JD Fu Y Zhu PD. Estrogen and progesterone receptors in human decidua after RU486 treatment. Fertil Steril 1993;60:69–74.

Ulmann A. Development of mifepristone. J Am Med Womens Assoc 2000;55(3 suppl):117–20.

Spitz IM Bardin CW Benton L Robbins A. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998;338:1241–7.

21 CFR 314.126 e.

Statistical review and evaluation of mifepristone. May 21, 1996, p.7-8. www.fda.gov/cder/foi/nda/2000/20687_Mifepristone_statr.pdf (accessed 2003 Oct 18).

Summary of findings, memorandum accompanying FDA form 483 issued to Dr. Elizabeth Aubeny (June 28, 1996) FDA FOIA release (MIF 004135- 45). Rockville, MD: Food and Drug Administration, 1996.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. www.fda.gov/cder/guidance/index.htm (accessed 2003 Oct 18).

FDA Subpart H Final Rule. New drug, antibiotic, and biological drug product regulations; accelerated approval. Final rule, 57 Fed. Reg. 58942 (Dec 11, 1992). www.fda.gov/cder/fedreg/fr19921211.txt (accessed 2003 Oct 18).

NDA's approved under Subpart H. www.fda.gov/cder/rdmt/accapp.htm (accessed 2003 Oct 18).

NDA Supplements approved under Subpart H. www.fda.gov/cder/rdmt/accappr1.htm (accessed 2003 Oct 18).

Zimmerman R. Clash between pharmacia and FDA may hinder the use of RU- 486. Wall Street Journal Oct. 18, 2000:B1.

Advertising and promotion; guidances. Notice, 61 Fed Register 1996 (Oct 8):52,800.

Cullen M. Open letter to health care providers. Skokie, IL: August 23, 2000. FDA FOIA Release: MIF 008022.

Hale RW Zinberg S. The use of misoprostol in pregnancy. N Engl J Med 2001;334:59–60.

Centers for Disease Control and Prevention. Abortion surveillance-United States, 1997. (MMWR) Morbid Mortal Wkly Rep 2000;49(SS-11).

Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. Final rule. Fed Register 1998;63(Dec 2):66632.

Guidance for industry: E11 clinical investigation of medicinal products in the pediatric population. www.fda.gov/cder/guidance/4099FNL.PDF (accessed 2003 Oct 18).

Mifeprex approval letter to Sandra P. Arnold, Population Council. Feb 18, 2000. www.fda.gov/cder/foi/appletter/2000/20687appltr.pdf (accessed 2003 Oct 18).

Food and Drug Administration. Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients. 66648 (1998).

FDA medical review. Inclusion and exclusion criteria. www.fda.gov/cder/foi/nda/2000/20687_Mifepristone_medr_P1.pdf (accessed 2003 Oct 18).

Medical management of abortion. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician Gynecologists 2001;26(4):1–20.

FDA proposed restricted distribution system for NDA 20–687 on 6/1/00. Rockville, MD: Food and Drug Administration, June 1, 2000:MIF 000522.

Teleconference meeting minutes. Re: status of pending review issues pertaining to this drug product (Aug. 11, 2000) and Mifeprex approval memo. Rockville, MD: Food and Drug Administration, August 11, 2000:MIF 004587–88.

American College of Obstetricians and Gynecologists. Analysis of the possible FDA mifepristone restrictions. Rockville, MD: Food and Drug Administration, July 27, 2000:MIF 001366–69.

Creinin MD Jerald H. Success rates and estimation of gestational age for medical abortion vary with transvaginal ultrasonographic criteria. Am J Obstet Gynecol 1999;180(1 pt 1):35–41.

Danco Laboratories. Open letter to health care providers (Apr. 19, 2002). (Dear doctor letter) www.fda.gov/medwatch/SAFETY/2002/mifeprex_deardoc.pdf (accessed 2003 Oct 18).

Population Council announces death of woman involved in Canadian mifepristone/misoprostol trial. Daily Reproductive Health Report (Sept. 11, 2001). www.kaisernetwork.org/Daily_reports/rep_index.cfm?DR_ID=6877 (accessed 2003 Sept 21).

AERS report, ISR number 3819498–2. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, November 2, 2001.

AERS report, ISR number 3806144–7. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, October 9, 2001.

AERS report, ISR number 3769840–6. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, July 30, 2001.

AERS report, ISR number 3769842-X. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, July 30, 2001.

AERS report, ISR number 3719885–7. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, May 8, 2001.

AERS report, ISR number 3713452–7. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, April 27, 2001.

AERS report, ISR number 3769838–8. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, July 30, 2001.

AERS report, ISR number 3803789–5. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, October 3, 2001.

AERS report, ISR number 3815629–9. Rockville, MD: Food and Drug Administration Office of Postmarketing Drug Risk Assessment, October 26, 2001.

Mifepristone questions and answers. 4/17/02. www.fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa_4_17_02.htm (accessed 2003 Oct 18).

Joint Commission on Accreditation of Healthcare Organizations. www.jcaho.org/sentinel/se_pp.html#Rootcauseanalysis (accessed 2003 Sept 21).

RU- 486 Suspension and Review Act of 2003 (H.R. 3453). Introduced 11/6/2003. http://thomas.loc.gov (accessed 2003 Dec 2).

RU-486 Suspension and Review Act of 2003 (S. 1930). Introduced 11/21/2003. http://thomas.loc.gov (accessed 2003 Dec 2).