Emergency Contraception (EC) in the U.S.
Part 1: 1998 to 2011-APR: Making Plan B &
Plan B One-Step available to younger teens
1998 to 2001: Gradual relaxation of accessibility and age limits for the sale of EC:
Initially, two types of emergency contraception were available in the U.S., but only by a physician's prescription, and only to women 18 years-of-age or older:
- Preven, made by Gynetics Inc., and
- Plan-B, made by Women's Capital Corp.
With emergency contraception, speed is of the essence. Unfortunately, access to physicians is difficult over two and three day weekends, and at other times. Women were sometimes unable to obtain EC quickly enough for the medication to be highly effective. Circa 1998, pharmacists in Washington State started to dispense EC to women without a prescription, after pharmacists first checked their age to make certain they were eligible. Opponents suggested that allowing pharmacists to dispense emergency contraception might result in some women using them as a form of birth control. That appears to have not been a serious problem. Within a few years, about 30,000 women were successfully served without prescriptions in that state. On 2001-JAN-01, California began a pilot study patterned after the Washington State model.
Also in 2001, more than 60 medical, public health and women's groups initiated a petition asking the federal Food and Drug Administration (FDA) to make EC pills available over the counter (OTC) by a pharmacist to women who were 17 years-of-age or older. 1 A FDA
panel later recommended this change to the FDA executive. OTC sales were subsequently approved nation-wide for women in that age range.
Some Republicans in Congress had threatened to cut the FDA's budget if the agency allowed women under the age of 17 to obtain the drug without a prescription. This decision appears to be counter-productive. Making emergency contraceptive more difficult to obtain will increase the number of unwanted and unexpected pregnancies. Among women of all ages, about 40% of such pregnancies are terminated by abortion. However young teens who find themselves unexpectedly pregnant have an even higher abortion rate. Thus, preventing younger teens from easily and quickly obtaining EC would significantly increase the abortion rate -- something that essentially all Republicans normally oppose.
The reason for the Republican's threat apparently lies in a conflict between the two conflicting belief systems in circulation about EC:
- Religious conservatives generally believe that EC is always an abortifacient, or can sometimes act as an abortifacient -- an abortion inducing drug. This is based on their belief that EC always or sometimes prevents the implantation of a zygote -- a fertilized ovum -- in the inner wall of the uterus. Conservative religious news sources regularly refer to EC as an abortifacient. Thus, they oppose both women taking the pill shortly after unprotected intercourse and those having a surgical abortion later.
- Religious liberals, EC developers and researchers, and the medical profession generally believe that EC only works by delaying ovulation or -- if ovulation has already occurred -- by impeding fertilization. It has no effect on the implantation by zygotes in the uterine wall. Their news sources regularly refer to EC as a form of contraception. All the available scientific evidence points to this belief being correct.
Because of the close link between the Republican Party and conservative Christians, most Republicans look upon EC negatively. They also see an additional problem with making EC available to younger women: it permits them to make independent decisions about their bodies and their future without having to involve their parents.
2011-DEC: FDA revisits EC:
In late 2011, a FDA panel studied ECs again. More than a decade of use had showed that EC is quite safe. The panel supported a policy of allowing broader OTC access to emergency contraceptives with no age restriction. This decision was supported by the FDA Commissioner Margaret Hamburg on 2011-DEC-06. However, Health and Human Services Secretary Kathleen Sebelius took the very unusually step of vetoing both the Commissioner and expert panel by keeping non-prescription access only to women 17 years-of-age and older. This was an important decision, because the average age at which youths become sexually active is 16. Many young women start to be sexually active years before they reach that age.
Secretary Sebelius issued a statement on 2011-DEC-07 saying:
"It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non-prescription availability of this product for all ages."
President Obama supported her decision. This led to accusations that he was trying to placate social conservatives to gain votes in advance of the 2012 elections. 2
NARAL Pro-Choice America said in a statement:
"We expected this kind of action from the Bush administration, so it’s doubly disheartening and unacceptable that this administration chose to follow this path."
Rep. Henry Waxman (D-CA) said:
"I think it’s very unfortunate the secretary made the decision that she did. The FDA is a scientific agency, and ... [the panel] gave her their recommendation based on the science. ... I think she should have followed it." 3
2012-NOV-20: National organizations of physicians make statements about oral contraceptives and EC:
The American College of Obstetricians-Gynecologists (ACOG) recommended that the FDA make oral contraceptives available over the counter (OTC). This also included EC. They reasoned that the risks associated with dispensing drugs without a prescription are outweighed by the benefits derived from reducing unwanted pregnancies. 4
On NOV-26, the American Academy of Pediatrics (AAP) urged its physician members to prescribe EC for adolescent girls aged 16 years and younger in advance of need. They made a policy statement that if a physician objects on moral grounds to prescribing EC to a teenager, they are obligated to refer their patient to a physician who will. They note that the teenage birth rate in the U.S. has declined substantially over the previous two decades. However, it remains higher than the rate in other industrialized nations. 5
2013-APR-04: Federal court activity:
With a flurry of new laws in many states intended to limit women's access to abortion, increasing pressure was being generated to remove federal and state barriers to women's access to emergency contraceptives. 6
A lawsuit filed by a number of reproductive rights groups challenged Kathleen Sebelius' 2011 decision. On 2013-APR-04, Judge Edward Korman -- a judge in the Brooklyn, NY federal district court -- ordered the Food and Drug Administration (FDA) to make the Plan B One-Step emergency contraceptive available within 30 days without a prescription to all women and post-pubertal girls. He criticized senior Obama administration officials whom he believed had interfered in the approval process. He regarded Sebelius' decision in 2011-DEC as:
"... arbitrary, capricious and unreasonable. The motivation for the secretary's action was obviously political."
He also called the decision:
"... politically motivated, scientifically unjustified, and contrary to agency precedent." 9
The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society of Adolescent Health and Medicine issued a joint statement saying that:
"This [court] decision reflects the overwhelming evidence that emergency contraception is safe and effective for all women of reproductive age." 7
Dr Michael Greene, professor of obstetrics and gynecology at Harvard Medical School and a long-time adviser to the FDA, said that the earlier FDA decision:
"... was an act of cowardice. It was during the run-up to the 2012 election, and the administration didn't want the Republicans to beat them over the head with this."
Jon O'Brien is president of Catholics for Choice, an agency that supports women's access to birth control, emergency contraception, and abortion. O'Brien said:
"In the first days of the administration in 2009, we were told that this White House would make science- and fact-based decisions. ... [Keeping age restrictions on EC] was an exact example of a politically motivated decision, which makes it even more shameful." 6
Nancy Northup, president of the Center for Reproductive Rights said:
"This landmark court decision has struck a huge blow to the deep-seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods. ... Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception." 8
This topic continues in Part 2
The following information sources were used to prepare and update the above
essay. The hyperlinks are not necessarily still active today.
- "California's OTC emergency contraception law takes effect next week," e-Med, 2001-DEC-29, at: http://www.e-med.co.il/
- Jessica Dye, "U.S. judge widens 'morning-after' pill access for young girls," Chicago Tribune, 2013-APR-05, at: http://www.chicagotribune.com/
- Sam Baker, "Sebelius overrules FDA, blocks access to morning-after pill," The Hill, 2011-DEC-07, at: http://thehill.com/
- "Over-the-Counter Access to Oral Contraceptives: Committee Opinion," The American College of Obstetricians and Gynecologists, 2012-DEC, at: http://www.acog.org/
- Robert Lowes, "Prescribe Morning-After Pill to Teens Before Need, Says AAP," Medscape, 2012-NOV-27, at: http://www.medscape.com/
- "Edward R. Korman," Wikipedia, as on 2013-JUN-09, at: https://en.wikipedia.org/
- Robert Lowes, "Morning-After Pill Must Be OTC for All Ages, Judge Rules," Medscape, 2013-APR-05, at: http://www.medscape.com/
- Katie McDonough, "FDA ordered to lift age restrictions on “morning after pill," Salon, 2013-APR-05, at: http://www.salon.com/
- Alex Wagner, "Obama administration ends resistance to Plan B availability," MSN, 2013-JUN-11, at: http://video.msnbc.msn.com/
Copyright © 1999 to 2013, by Ontario Consultants on
Originally published on 1999-JAN-13
Latest update: 2013-JUN-13
Author: B.A. Robinson