Emergency Contraception: Developments in Access

By Nikki Tishler, SIECUS Federal Policy and Communications Fellow

Access to emergency contraception (EC) in the United States has been a controversial issue for well-over a decade. However, the debate peaked beginning in April 2013 over developments related to the lifting of age or point-of-sale restrictions for Plan B One-Step, the single pill version of EC. A brief overview of the EC access controversy, informed in large part by resources from the Center for Reproductive Rights (CRR) and the Reproductive Health Technologies Project (RHTP), including more recent events, is provided below.

July 1999:  The Food and Drug Administration (FDA) approves the first levonorgestral-based EC, Plan B, for prescription use.[1]

February 2001:  CRR and RHTP, on behalf of over 70 medical and public health organizations, file a Citizen Petition with the FDA to switch emergency contraception drugs from prescription-only to over-the-counter (OTC) status.[2]

April 2003:  Women’s Capital Corporation, the manufacturer of Plan B, files an application with the FDA to make Plan B available OTC.[3]

May 2004:  The FDA denies the application and suggests Barr, the new Plan B manufacturer, amend the application to request OTC status only for women 16 and older.[4]

January 2005:  CRR sues the FDA for ignoring scientific evidence and holding Plan B to a different standard than other drugs, after the FDA failed to meet its deadline concerning Barr’s revised application.[5]

August 2006:  The FDA approves the distribution of EC without a prescription, but only behind the counter at pharmacies and only to women 18 or older with a government-issued ID.[6]

March 2009:  U.S. District Court Judge Edward Korman rules that the FDA’s decision placed politics before women’s health and orders the FDA to extend OTC access to women 17 years of age, making Plan B, Plan B One-Step, and Next Choice (a generic two-pill version) available to anyone 17 or older without a prescription.[7]

February 2011:  Teva Pharmaceutical Industries (Teva), the current manufacturer of Plan B and Plan B One-Step, files a supplemental new drug application (SNDA) with the FDA requesting OTC access without age restrictions.[8]

December 7, 2011:  Margaret Hamburg, Commissioner of the FDA, announces that the FDA is prepared to approve the SNDA, but in an unprecedented move, Kathleen Sebelius, Secretary of Health and Human Services, directs the FDA to deny the SNDA.[9]

February 2012:  CRR reopens its case, adding Secretary Sebelius as a defendant and supplements the complaint.[10]

April 5, 2013:  U.S. District Court Judge Edward Korman orders the FDA to make levonorgestrel-based emergency contraceptives available OTC without point-of-sale (i.e. behind the counter) or age restrictions.[11]

April 30, 2013:  The FDA responds to the court order by approving Plan B One-Step to be sold OTC and without a prescription to women ages 15 and older, with identification.[12]

May 13, 2013:  The U.S. Department of Justice files an appeal with the Second Circuit Court of Appeals asking to overturn Judge Korman’s court order.[13]

June 5, 2013:  The Second Circuit Court of Appeals partially denies the Federal Government’s request to stay, requiring immediate compliance with Judge Korman’s court order.[14]

June 10, 2013:  The Obama administration drops its appeal, allowing Plan B One-Step to be available OTC with no age restrictions or point-of-sale restrictions.[15]

June 12, 2013:  Judge Edward Korman accepts the Obama Administration’s plan.[16]

June 20, 2013:  The FDA officially approves the use of Plan B One-Step as a nonprescription product without age or point-of-sale restrictions.[17]

The final ruling ensuring the removal of an age-restriction on Plan B One-Step represents a reproductive health victory securing increased access to this specific brand of EC. Teva has indicated that Plan B One-Step could be on store shelves by the end of July/early August. While this reproductive health achievement should be celebrated, a number of concerns remain regarding the decision and the future of EC access. For instance, the decision is specific only to Plan B One-Step; restrictions remain for generic one-pill versions and all two-pill versions of EC. Given this, it is possible that the FDA will grant marketing exclusivity to Teva, giving them a near-monopoly that could drive up the cost of EC and inhibit the development of less expensive generic variants for at least three years. Plan B One-Step is already one of the most expensive versions of EC available, costing as much as $70 compared to two-pill generic versions which can cost as little as $10.[18] Future debates and controversies lie ahead in expanding access to, and ensuring the affordability of, all forms of emergency contraception.

[1]“Original New Drug Application (NDA and BLA) Approvals July 1999,” U.S. Food and Drug Administration, accessed June 17, 2013, http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.NewOriginalNDA.

[2]“Important Milestones in the History of FDA Approved Emergency Contraception Options,” Reproductive Health Technologies Project, (December 14, 2011), accessed June 17, 2013, http://www.rhtp.org/contraception/emergency/documents/ImportantMilestonesintheHistoryofFDAApprovedEmergencyContraceptiveOptions_002.pdf.

[3]“The Fight for Emergency Contraception: Every Second Counts,” Center for Reproductive Rights, accessed June 17, 2013, http://reproductiverights.org/en/emergency-contraception-timeline.

[4]Steven Galson, M.D., M.P.H., “Plan B – Not Approvable Letter,” U.S. Food and Drug Administration, accessed June 17, 2013, http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM109793.pdf.

[5]“The Fight for Emergency Contraception,” Center for Reproductive Rights.

[6]Steven Galson, M.D., M.P.H., “Approval Letter – Plan B (levonorgestrel) Tablets, 0.75 mg,” U.S. Food and Drug Administration, (August 24, 2006), accessed June 17, 2013, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109775.htm.

[7]U.S. Food and Drug Administration, “Updated FDA Action on Plan B (levonorgestrel) Tablets,” Press Release published April 22, 2009, accessed June 17, 2013,http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149568.htm.

[8]“The Fight for Emergency Contraception,” Center for Reproductive Rights.

[9]U.S. Food and Drug Administration, “Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step,” Commissioner Statement published December 7, 2011, accessed June 17, 2013, http://www.fda.gov/NewsEvents/Newsroom/ucm282805.htm.

[10]“ Tummino v. Hamburg (NY),” Center for Reproductive Rights, accessed June 17, 2013, http://reproductiverights.org/en/case/tummino-v-hamburg-ny.

[11]Annie Tummino, et al., v. Margaret Hamburg, Commissioner of Food and Drugs, et al. (E.D.N.Y. April 5, 2013), accessed June 17, 2013, https://www.nyed.uscourts.gov/sites/default/files/opinions/Tummino%20SJ%20memo.pdf.

[12]U.S. Food and Drug Administration, “FDA Approves Plan B One-Step Emergency Contraception Without a Prescription for Women 15 Years of Age and Older,” Press Release published 30 April 2013, accessed June 17, 2013, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm.

[13]Catherine O’Hagan Wolfe, “United States Court of Appeals for the Second Circuit,” (June 5, 2013), accessed June 18, 2013, http://www.scribd.com/doc/145909756/2nd-Circuit-Court-of-Appeals-Stay-Order-on-emergency-contraception.


[15]Loretta Lynch, “Justice Letter Re: Tummino v. Hamburg, No. 12-CV-0763 (ERL/VVP),” U.S. Department of Justice, June 10, 2013, accessed June 18, 2013, http://media.npr.org/documents/2013/jun/justiceletter.pdf.

[16]Annie Tummino, et al., v. Margaret Hamburg, Commissioner of Food and Drugs, et al. (E.D.N.Y. June 12, 2013), accessed June 17, 2013, https://www.nyed.uscourts.gov/sites/default/files/opinions/12-763m106.pdf.

[17]U.S. Food and Drug Administration, “FDA Approves Plan B One-Step Emergency Contraceptive for use Without a Prescription for all Women of Child-bearing Potential,” (June 20, 2013), accessed June 21, 2013, http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm358082.htm.

[18]“Morning After Pill (Emergency Contraception),” Planned Parenthood, accessed June 18, 2013, http://www.plannedparenthood.org/health-topics/emergency-contraception-morning-after-pill-4363.asp.

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