By: Bansri Patel
As of May 1st 2013, Plan B®, the brand name emergency contraception pill will now be available to women aged fifteen and older. It will also be sold in the drug store aisles, as opposed to its current location behind the pharmacy counter.
When levonorgestrel (Plan B®) first entered the market, its purchase was restricted to those over seventeen years of age. This drug is shrouded in controversy because many believe it to be an abortifacient. However, levonorgestrel does not precipitate an abortion but rather prevents ovulation or fertilization by altering tubal transport of sperm and/or ova. If the egg has already reached the uterus, levonorgestrel prevents the egg from latching onto the uterine wall. Side effects include nausea, abdominal pain, and menstrual changes. Levonorgestrel does not harm an existing fetus, nor does it prevent an existing pregnancy. It also cannot prevent sexually transmitted diseases and HIV. Levonorgestrel is not meant to be used routinely as a means of birth control.1
Plan B® has been proven to be safe and effective in women aged seventeen and older, but it is also expected to have the same safety and efficacy when taken by post-pubertal adolescents younger than 17.2 Professional groups, such as the American Association of Pediatrics, have advocated the use of levonorgestrel in a younger population. As promulgated in AAP’s official stance on Emergency Contraception for Adolescents, “The AAP encourages abstinence plus comprehensive sexuality education as the best way to help prevent unintended pregnancy and sexually transmitted diseases. Ensuring access to contraception – including emergency contraception – and educating sexually active adolescents on proper use and indications of the various methods are essential components to comprehensive sexuality education.”3
In 2011, Kathleen Sebelius, the secretary of Health and Human Services overrode the FDA’s decision to make Plan B® over the counter and without age restriction. Her verdict was based on the lack of sufficient evidence to prove that the pill was safe for girls aged fifteen and younger and the uncertainty that adolescents in this age group were capable of fully understanding how to use the medication. Many adolescents reach puberty at the age of eleven, and she cited “significant cognitive and behavioral differences” between older adolescents and “the youngest girls of reproductive age.”4 One specific concern was that young girls would inappropriately use levonorgestrel for routine birth control instead of its intended use in emergency situations. Furthermore, levonorgestrel carries the risk of being misconstrued as a means of STD prevention.. Kathleen Sebelius’s decision retained levonorgestrel’s status as only available to women aged 17 and older without a prescription. Any women below the age of seventeen would need a prescription from a physician to obtain the medication.5
In 2012, Teva, the pharmaceutical company that manufactures Plan B®, filed an amended New Drug application that would allow access to fifteen year olds. Margaret Hamburg, the FDA commissioner said, “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step® works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”6 Teva submitted a study and label comprehension data showing that females in this age group were able to comprehend how the medication was to be used and did not need a healthcare provider’s approval to take the medication. The new Plan B® labels will now state that females aged fifteen and older may take the emergency contraceptive with proof of identification.6 Kathleen Sebelius indicated that she is now comfortable with FDA’s decision to lower the age limit, as there is now sufficient evidence to prove that adolescents aged fifteen and older have the cognitive capacity to understand directions for the appropriate use of levonorgestrel. President Obama has also backed FDA’s decision. He issued a statement in a recent press conference, “The rule that’s been put forward by the FDA, Secretary Sebelius has reviewed. She’s comfortable with it; I’m comfortable with it”.7
In a recent court ruling, Federal Judge, Edward R. Korman, of the Eastern District of New York, ruled that levonorgestrel or Plan B One Step® should be sold without age restrictions. He claimed that the Obama Administration’s previous decision to limit the access of the medication was politically charged and had no scientific backing. He accused the Obama Administration of choosing politics over science. During this time, the FDA was still reviewing Teva’s application to market Plan B One Step® to those aged fifteen and older and the FDA’s decision to lower the age was not associated with the court order.1 The Obama Administration has decided as of May 3, 2013, that it will appeal the Judge’s decision.7
- Full Product Information. Plan B One-Step. http://www.planbonestep.com/pdf/PlanBOneStepFullProductInformation.pdf. Accessed May 3, 2013.
- Taylor, Amy M., MD, MHS. Pediatric Focused Safety Review: Plan B One-Step Pediatric Advisory Committee Meeting January 30, 2011 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM289946.pdf. Accessed May 4, 2013.
- AAP Issues New Statement On Emergency Contraception For Adolescents. American Academy of Pediatrics. http://www2.aap.org/advocacy/releases/sept05contraception.htm. Updated 2012. Accessed May 3, 2013.
- Kendall B, Anderson M. Restricted Access to Plan-B Pill Overturned. The Wall Street Journal. April 9, 2013. http://online.wsj.com/article/SB10001424127887324600704578404393383162004.html. Accessed May 4, 2013
- Belluck P. Drug Agency Lowers Age For Next-Day Birth Control. The New York Times. April 30, 2013. http://www.nytimes.com/2013/05/01/health/fda-lowers-age-for-morning-after-pill.html?src=recg&_r=0. Accessed May 4, 2013
- FDA approves Plan-B One-Step emergency contraceptive without a prescription for women 15 years of age and older. News & Events: FDA News Release. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350230.htm. Updated April 30, 2013. Accessed May 3, 2013.
- O’Brien M. Obama ‘comfortable with FDA’s lowered age limit for ‘Plan B.’ First Read on NBCNews.com http://firstread.nbcnews.com/_news/2013/05/02/18023867-obama-comfortable-with-fdas-lowered-age-limit-for-plan-b?lite. Updated May 2, 2013. Accessed May 4, 2013.