Emergency Contraception: Controversies and Advocacy
The Fight for Fair and Science-based Regulation
Sarah Michelsen, Lisa Kernan Social Justice Fellow, and Ellen R. Shaffer, Co-Director,
Trust Women/ Silver Ribbon Campaign, a project of The Center for Policy Analysis
Transcribed from Sarah Michelsen’s Power Point presentation, San Francisco, July, 2013
What is Emergency Contraception?
Myths and Facts
What is Emergency Contraception?
A safe and effective birth control method used after unprotected sex to prevent pregnancy
If regular birth control was used incorrectly or fails, or after sex without birth control
Recommended for use after a more reliable method fails, or is not used
How Does Progestin-Only Emergency Contraception Work?
Progestin-only EC works by preventing ovulation (the egg cell leaving the ovary).
It used to be thought that progestin-only EC could also prevent fertilization (the sperm and egg joining) or the implantation of a fertilized egg (blastocyst) after ovulation, but that has now been debunked.
The newest studies show the progestin-only EC is only effective before ovulation-if an egg is already present in the fallopian tube, EC will not be effective.
Myths and Facts about Progestin-Only Forms of EC
Myth: Progestin-only forms of EC, including Plan-B One Step and Next Choice, can cause abortions.
Fact: Progestin-only forms of EC work by preventing ovulation. They have no effect on a fertilized blastocyst before or after implantation.
Myth: Progestin-only forms of EC will cause birth defects or otherwise harm an embryo if the woman is already pregnant.
Fact: Progestin-only forms of EC have no negative effects on developing embryos, either before or after implantation.
Other Types of EC
Combined progestin and estrogen pill –rarely used
Ulipristal acetate pill
Combined Progestin and Estrogen Pills
The same as regular birth control pills, in a larger dose.
None currently marketed as EC, although several brands of regular birth control have been approved by the U.S. Food and Drug Administration (FDA) for use as EC.
Women in rural areas or situations where they cannot access regular EC may take larger doses of their regular birth control pills to act as EC, but this is not as effective as a progestin-only form of EC.
Ulipristal Acetate Pills
Marketed in the US as Ella
Available by prescription only, for women of all ages
Significantly more effective than other methods at preventing ovulation, especially between 72 and 120 hours.
May have some post-ovulation effect, including possibly preventing implantation after fertilization has occurred.
Not an abortifacient-does not meet medical definition of an abortion,which is interrupting an established pregnancy, after a fertilized blastocyst is successfully implanted in the uterus.
Must be prescribed and insderted by a doctor or other trained clinician
Reduces the risk of getting pregnantby more than 99%
Can be effectively inserted up to 5 days after unprotected sex
Can keep it in place for up to 10 years.
Opposition and Barriers to Access
Who is the Opposition to EC? Misleading Quotes
“The secret best kept from the American public is that these drugs can cause abortions. The time for covering up this unpleasant reality is long past.”
“It can irritate the lining of the uterus so that if the first and second actions fail, and the woman does become pregnant, the tiny baby boy or girl will die before he or she can actually attach to the lining of the uterus.”
[NOTE: This is NOT the official AAP –it’s a separate anti-choice rump group.]
“Despite self-reports denying it, ‘ready access’ to EC apparently increases the sexual activity of adolescents which is a risk factor for depression and suicide, poor school performance, more lifetime
Anti-choice leaders choose to define abortion differently from the medical definition.
The medical definition: interrupting an established pregnancy, after implantation of the fertilized egg [c. 50% of fertilized eggs do not implant].
Anti-choice position: Abortion includes even interrupting the release of the egg into the fallopian tube (ovulation)
Also: Confusion about the mechanisms of action of different forms of EC, and many believe that OTC forms of EC, progestin only pills, cause abortions.
Belief that ulipristal acetate forms of EC cause abortions.
Protecting” Women and Girls
Opponents have painted EC as a dangerous drug, and fanned fears that young girls accessing it without parental notification would lead to promiscuity.
Studies show increased access to EC does not increase promiscuity or reduce use of other contraceptives.
Scare tactics-US Conference of Catholic Bishops spokesperson said expanding access “undermines parents’ ability to protect their daughters … from the adverse effects of the drug itself.””
Why do Barriers to Accessing EC Matter?
Need for ID is shaming and stigmatizing.
Need to find an open pharmacy, regardless of age.
Precludes immigrant women, young women, or others without ID from purchasing, regardless of age.
Creates a barrier for the trans* community.
Disproportionately affects low income women and women of color.
Confusion among the public and pharmacists about who can and can’t purchase leads to older teens and men being denied their right to purchase EC.
Young women under the age of 15 seeking EC are the most vulnerable, and yet have the highest barriers to purchase.
HIGH COST CAN REMAIN A BARRIER –Insurance should cover
The Long Fight for Fair Access
Over a decade of court battles and politically motivated decisions
The Fight for Fair Access
EC first approved by the FDA in 1999
2004: The non-partisan scientific committee assigned by FDA to review the evidence on safety and effectiveness voted 23 to 4 to approve an application to make EC available over the counter without any age restrictions.
Recommendation supported by 50+ medical/health organizations
2005: FDA commissioner overruled decision of the FDA scientific committee
Aug.2005: Dr. Susan Wood resigned as FDA Director of Women’s Health and Assistant Commissioner for Women’s Health in protest political influence over science.
Science Vs. Politics
In 2006 EC was made available OTC for those over 18
In 2009 a court ordered the FDA to review that decision, calling it arbitrary and capricious, and to immediately lower the age to 17. FDA lowered age restriction but did not reconsider making it available to all women OTC.
In 2011 FDA Commissioner announced they were prepared to grant Teva’s application to remove all age restrictions on OTC sale-but this decision was blocked by HHS Secretary Sebelius.
Unprecedented for HHS Sec, to overrule her appointed FDA chief .
The Fight For Fair Access: 2013
April 5, 2013-U.S. District Court Judge Edward Korman ordered the FDA to make Plan B and generics of the two-pill medication available for OTC sale to people of all ages.
April 30 2013-FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
May 1 2013-Department of Justice files appeal, and moves for a stay pending the appeal.
May 10 2013-Judge Korman refuses to grant the stay
Judge Korman Calls Out the Administration
“You made that announcement to sugar-coat this appeal.”
“The bottom line is that it’s not possible to provide the data on 11-and 12-year-olds,” Judge Korman said. “You’re using these 11-and 12-year-olds to place an undue burden on the ability of older women to get this contraceptive.”
“These emergency contraceptives would be among the safest drugs sold over the counter.”
“If this were a voting rights case, you’d be here telling me this was voter suppression,” he said. “You’re disadvantaging poor people, young people, and African Americans. That’s the policy of the Obama administration?”
Victory? And What’s Next?
June 11, 2013-Obama administration announces in a letter to Judge Korman that they will accept court defeat, and no longer pursue an appeal.
June 12-Judge Korman approves administration’s plan to comply.
What Did We Win? The Who What and Where of EC SalesOnce this is all implemented…
|The Who What and Where of EC SalesOnce this is all implemented… Product||Who Can Purchase, OTC or Prescription||Location||Point of Sale Restrictions|
|Plan-B One Step||Everyone||Retail Shelf||none|
|Next Choice One Dose (and any other generics)||Age 17 and Older: OTCUnder 17: Prescription Only||Behind Pharmacy Counter||must ask pharmacist and show ID|
|Next Choice, Levonorgestrel Tablets, and other 2-pill generics||Age 17 and Older: OTCUnder 17: Prescription Only||Behind Pharmacy Counter||must ask pharmacist and show ID|
|Ella and Ulipristal acetate generics||Prescription only for all ages||Behind Pharmacy Counter||Must ask pharmacist to fill prescription|
What Do Advocates Need to Be Aware Of?
Only makes Plan-B One Step available OTC with no age restrictions. Two-pill versions of the drug will still require a prescription if under age 17.
Gives marketing exclusivity to Teva, preventing generic forms from being available OTC for at least 3 years.
Administration says that the re-labeling process will happen “without delay.” Really?
What Should Advocates Do?
Hold the Administration accountable for sticking to their compliance plan in a timely manner
Keep the public informed and pressure the Administration and FDA to continue to make more forms of EC, and other types of birth control, widely available.
Propose ways to keep the cost of EC down, and prevent future marketing exclusivity that create monopolies
Inform the public about the decision and how their access to EC will change, as well as hold the administration accountable for doing the work to educate the public.
American College of Pediatricians. “Emergency Contraception Should Not Be Passed out like Candy.” LifeSiteNews. N.p., 4 Dec. 2012. Web. 19 June 2013.
Bapat, Sheila. “Justice Doesn’t Just Happen: Feminist Activists Were Essential to EC Ruling.” RH Reality Check. N.p., 24 Apr. 2013. Web. 19 June 2013.
Boonstra, Heather. “Emergency Contraception: Steps Being Taken to Improve Access.” Emergency Contraception: Steps Being Taken to Improve Access. The GuttmacherReport on Public Policy, Dec. 2012. Web. 19 June 2013.
”Center for Reproductive Rights Reopens Lawsuit Against FDA Restrictions on
Emergency Contraception.” Center for Reproductive Rights. N.p., 8 Feb. 2012. Web. 19 June 2013.
“The Fight for Emergency Contraception: Every Second Counts.” Center for Reproductive Rights. N.p., n.d.Web. 19 June 2013.
Jacobson, Jodi. “Court Orders FDA to Make Emergency Contraception Available Over-the-Counter for All Ages.” RH Reality Check. N.p., 5 Apr. 2013. Web. 19 June 2013.
Jacobson, Jodi. “Judge Approves Administration’s Strategy for EC Over-the-Counter …With Reservations.” RH Reality Check. N.p., 12 June 2013. Web. 19 June 2013.
Jefferson, Erica. “FDA Approves Plan B One-Step Emergency Contraceptive without a Prescription for Women 15 Years of Age and Older.” US Food and Drug Administration. US Food and Drug Administration Press Release, 30 Apr. 2013. Web. 19 June 2013.
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Kempner, Martha. “Http://rhrealitycheck.org/article/2013/06/17/plan-b-becomes-available-to-women-of-all-ages-but-everyone-should-have-a-plan-a/.” RH Reality Check. N.p., 17 June 2013. Web. 19 June 2013.
Mozzanego, Bruno. “Ulipristal Acetate in Emergency Contraception: Mechanism of Action.” Trends in PharmologicalSciences34.4 (2013): n. pag. Print.
Noé, Gabriela, HoracioB. Croxatto, Ana MaríaSalvatierra, VerónicaReyes, Claudio Villarroel, Carla Muñoz, Gabriela Morales, and Anita Retamales. “Contraceptive Efficacy of Emergency Contraception with Levonorgestrelgiven before or after Ovulation.” Contraception84.5 (2011): 486-92. Print.
Trussell, James, PhD, and Elizabeth Raymond, MPH, MD. “Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy.” Princeton University, June 2013. Web. 19 Apr. 2013.
Tumminov. Hamburg. UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK. 4 Apr. 2013. US District Court Eastern District of New York. N.p., 4 Apr. 2013. Web. 19 Apr. 2013.
United States Attorney, Eastern District of New York. “Re : Tummino v. Hamburg , No. 12 -CV -0763 (ERK/VVP).” Letter to Honorable Edward R. Korman. 10 June 2013. N.p., n.d. Web. 19 June 2013.
Wills, Susan E., Esq. “Emergency Contraception -Boon or Bane?” Emergency Contraception -Boon or Bane?United States Conference of Catholic Bishops, n.d. Web. 19 June 2013.
Zaidi, Sidra. “Emergency Contraception and Moral Panic: Dissecting the Newest Misinformation Campaign.” RH RealityCheck. RH Reality Check, 9 Apr. 2013. Web. 19 June 2013.
For More Information
Princeton University Office of Population Research
American College of Obstetricians and Gynecologists
TEDxBayArea Women -Sophia Yen -Cutting Edge Adolescent Medicine12/8/10
Department of Health and Human Services, Office of Women’s Health
Food and Drug Administration Birth Control Guide
Trust Women/Silver Ribbon CampaignPO Box 29586San Francisco, CA 94129415-922-6204www.oursilverribbon.org