Plan B: Context and Facts

Posted on | June 11, 2013 | 1 Comment

Mike Magee

This week the Obama administration gave the green light to unrestricted availability and sales of the morning-after contraceptive pill, Plan B. In the recent past U.S. District Judge Edward R. Korman had called the administration’s age restrictions “politically motivated” and “scientifically unjustified”. Without signaling a change in their opinion, the administration declined to continue its court case.(1) This is the latest brush up on a issue that is complex, contentious, but critical in the nation’s push to decrease the numbers of abortions. What is missing often in the heat of this debate is context and facts. Let’s have a look.

Support for birth control in America is close to universal, and now extends in emergencies, for up to 72 hours after unprotected pregnancy, to individuals in the US without parental permission and without a prescription.(2)

The use of Plan B and other forms of emergency contraception has steadily risen over the past six years. Approximately one-half of all US pregnancies are unintended (3,4). Plan B’s emergency contraceptive pill was first approved in 1998. Today four major brands are available over the counter for women aged 17 and over (5).

Usage reports recently released by the CDC contained a few surprises. But before we get to them, a few words on Plan B science.

Plan B is the distinctively neutral name applied to a product produced originally by Barr Laboratories as an emergency contraceptive. The product is the hormone Levonorgestrel. Its effect, when taken as a .75mg dose as soon as possible after unprotected intercourse, failed contraception or rape, and followed 12 hours later by a second dose, is to prevent implantation of a fertilized egg, thus avoiding unwanted pregnancies, and potentially decreasing the number of future abortions.(3)

Today, Plan B One-Step is available in a single dose form. Time is of the essence. If a woman initiates treatment within 24 hours of intercourse, the failure rate is .4 percent. But if it’s initiated between 48 and 72 hours after intercourse, the failure rate increases almost 7 times to 2.7 percent.(4)

Twenty-four hours was never much time to manage this process. The first step was knowing that Plan B existed. The second step was to obtain a prescription from a doctor. Next, you had to find a pharmacy that stocked Plan B (some didn’t and still don’t). And finally, you had to take the two pills as prescribed.

Since then, emergency contraceptives have been broadly publicized, gone over the counter and been made available without parental consent (where available) for those 17 and older. The safety track record has held up well. But controversy has always been a part of its history.

In 2003, the FDA leadership was challenged with the Plan B request to go OTC. It later rejected the recommendations of its own Advisory Committee and senior staff to approve this more accessible approach. As Dr. Susan Wood, former director of the FDA’s Office of Women’s Health, who resigned in protest, stated “…recommendations of an Advisory Committee that are strongly supported by the FDA’s review staff have rarely, if ever, been overturned at the highest level of the agency…”(4)

The action of the FDA’s Commissioner, who subsequently resigned, not to allow Plan B to be sold OTC, was viewed by some medical leaders to be at least in part the response to external pressure from social conservatives who believed that Plan B would increase teen promiscuity, teen pregnancy and sexually transmitted diseases. Yet, extensive scientific studies submitted with the original proposal to the FDA had already established this not to be the case. The rejection was clearly not the result of safety concerns. In December 2003, the FDA Advisory Committee of outside experts voted Plan B safe, 28 to 0. They also voted 23 to 4 to make the product available OTC.(4)

Ultimately OTC was approved for those 17 and older. The FDA subsequently moved to expand access to those under 17 in December 2011. However, the Secretary of Health and Human Services overruled the FDA decision.(6) Recently the American Academy of Pediatrics weighed in. They suggested that pediatricians “provide prescriptions/supply for teenagers to have on hand in case of future need (ie advanced provision). No pregnancy test is required before the use of levonorgestrel…Advanced provision increases the likelihood that teenagers will use emergency contraception when needed, reduces the time to use, and does not decrease condom or other contraceptive use.”(7)

Plan B One-Step earned Teva Pharmaceuticals over 90 million in 2011.(8) A recent CDC report of usage(9) contains a few surprises.

• In 2006–2010, among sexually experienced women aged 15–44, roughly one in nine (11% or 5.8 million) women had ever used emergency contraception, up from 4.2% in 2002.

• Most women who had ever used emergency contraception had done so once (59%) or twice (24%).

• Young adult women aged 20–24 were most likely to have ever used emergency contraception; about one in four had done so (23%).

• Almost 1 in 5 never-married women (19%), 1 in 7 cohabiting women (14%), and 1 in 20 currently or formerly married women (5.7%) had ever used emergency contraception.

• About one in two women reported using emergency contraception because of fear of method failure (45%), and about one in two reported use because they had unprotected sex (49%).

• Use of emergency contraception increased with educational attainment—12% of women with a bachelor’s degree or higher and 11% of women with some college education had ever used it. This compares with 7.1% of women who had a high school diploma or GED and 5.5% of women with less than a high school education.

• Non-Hispanic white and Hispanic women were more likely to have ever used emergency contraception (11%) compared with non-Hispanic black women (7.9%).

Next Steps? The FDA has asked the manufacturer of Plan B to submit an application to make the product available over the counter without restrictions. The agency says “Once FDA receives the supplemental application, the FDA intends to approve it promptly.”(1)

For Health Commentary, I’m Mike Magee

References:

1. Dennis B, Kliff F. Obama administration drops fight to keep age restrictions on Plan B sales. Washington Post. June 11, 2013. http://www.washingtonpost.com/national/health-science/obama-administration-drops-fight-to-keep-age-restrictions-on-plan-b-sales/2013/06/10/a296406e-d22a-11e2-a73e-826d299ff459_story.html

2. Grossman CL. New Surveys: Catholics Want Birth Control Coverage. USA Today. February 7, 2012.http://content.usatoday.com/communities/Religion/post/2012/02/contraception-catholic-bishops-obama-hhs/1#.UR0OSjl7SxJ

3. Plan B Web site. “What is Plan B?” Available at: http://www.planbonestep.com/

4. Wood AJJ, Drazen JM, Greene MF. A Sad Day for Science at the FDA. NEJM. 2005;353:1197-1199.http://www.nejm.org/doi/full/10.1056/NEJMp058222

5. Wood SF. Women’s Health and the FDA. NEJM. 2005;353:1650-51.http://www.nejm.org/doi/full/10.1056/NEJMp058225

6. HHS Secretary Sebelius Overrules FDA On Plan B. December 7, 2011.http://feminist.org/news/newsbyte/uswirestory.asp?id=13368

7. American Academy of Pediatrics Policy Statement: Emergeny Contraception. November 26, 2012.http://pediatrics.aappublications.org/content/early/2012/11/21/peds.2012-2962.full.pdf+html

8. Selyukh A. Reuters. Plan B Profits. http://www.reuters.com/article/2011/12/07/us-teva-planb-fda-idUSTRE7B61V120111207

9. Daniels K, Jones J, Abma J. Use of Emergency Contraception Among Women Aged 15-44: United States, 2006-2010.http://www.cdc.gov/nchs/data/databriefs/db112.htm