Tuesday, September 16, 2014
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One year after FDA ruling on emergency contraception . . . confusion

Removing the age restrictions on some brands of emergency contraception will help improve access for some adolescents. But significant barriers remain.

One year after FDA ruling on emergency contraception . . . confusion

One year ago, the Food and Drug Administration finally approved over-the-counter sales of Plan B One-Step without any age restrictions. In my latest book, The Morning After: A History of Emergency Contraception in the United States, I described how emergency contraception went from being a little-known birth control method used by a small percentage of health care providers and their patients to a dedicated product available without prescription. The first emergency contraceptives were introduced in the United States during the mid-1960s, shortly after the U.S. Supreme Court decision Griswold v. Connecticut declared that state law prohibiting the use of contraceptives violated the “right to marital privacy,” and well before the same right to privacy was extended to unmarried persons of any age. As late as the 1970s, only a small fraction of college and universities in the U.S. offered birth control services in the student health services. High school-age girls faced even more barriers. Although some states did allow unmarried people access to contraception, few allowed minors to get them without parental permission.

First, a quick definition: emergency contraception is a birth control method that is used after intercourse to prevent conception. Plan B One Step and it's generic equivalents can be used up to 72 hours following unprotected sex but is more effective if taken sooner. Emergency contraceptives prevent pregnancy by delaying or inhibiting ovulation. For more information go to the Emergency Contraception website.

Although most states long restricted minors' access to emergency contraceptives, health care providers were able to get around them by using legal exceptions that allowed for treatment of minors without parental consent in cases considered an emergency. Sexual assault cases fit the bill perfectly. So, the first uses of what was known colloquially as “the morning-after pill” were for rape victims treated in hospital emergency rooms. Activism by young people and their advocates eventually led to the removal of many restrictions on minors’ access to birth control. “If the right of privacy means anything, it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child,” the Supreme Court declared in Eisenstadt v. Baird in 1972.

Removing the age restrictions on some brands of emergency contraception will help improve access for some adolescents. But significant barriers remain. Initially, the FDA gave Teva, the manufacturer of Plan B One-Step, an exclusive three-year agreement that the drug would be only the emergency contraceptive available over-the-counter without age restrictions. In February, the FDA decided that its agreement with Teva was “too broad” and sent a letter to generic emergency contraceptive pill manufacturers allowing them to also sell their products over-the-counter. In order to maintain part of Teva’s exclusivity agreement, the FDA also required that generics such as My Way and Next Choice One Dose to have a label that says “for ages 17 and up” – although consumers will not have to show proof of age to purchase them. This means that Plan B One-Step will be the only emergency contraceptive pill without a “17 and up” label. If this is not confusing enough, a recent study in the Journal of Adolescent Health by Tracy Wilkinson, a pediatrician at Children’s Hospital of Los Angeles, discovered that pharmacy staff gave out misinformation to female callers posing as 17-year-old teens.

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Some health care providers have tried to eliminate these problems by making emergency contraception available to teenagers for free. These efforts have been controversial. Several years ago, there was a huge furor over a pilot program in New York City public schools called Connecting Adolescents to Comprehensive Healthcare (CATCH), which gave emergency contraceptives to students who requested them. In accordance with state law, students could obtain emergency contraception and other birth control methods without telling their parents in community clinics and school-based health centers. Although parents were given the opportunity to opt out of the program, some parents were outraged, as were some conservatives. Mona Davids, president of the New York City Parents Union, said emergency contraceptive was too dangerous to give without parents' permission: "They can't even give our kids aspirin or Motrin without informed consent. This is a chemical hormonal drug cocktail.” And Anne Leary, a conservative blogger from Chicago, said the measure was “ill-advised” and undermined parental authority. (Emergency contraception has never been available in Philadelphia public schools.)

Those of us over 17 should be concerned about this issue, and not just because it forces adolescents to accept the consequences of contraceptive failure that women over 18 don’t have to face. The inconsistencies in age restrictions on various emergency contraceptive products have allowed opponents of emergency contraception an entering wedge in their efforts to eliminate this birth control option completely. Over the past two decades, pro-life groups have been able to whittle away at women’s right to choose by first going after the most vulnerable groups. Women under 18 are an especially easy target because they can’t vote. The age restriction on over-the-counter emergency contraception has allowed opponents to circulate misinformation about who can legally obtain the drug without a prescription.

We can’t allow policy makers to sacrifice the needs of adolescent girls and divide reproductive health activists along generational lines. A threat to the rights of young women is a danger to us all.


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What is public health — and why does it matter?

Through prevention, education, and intervention, public health practitioners - epidemiologists, health policy experts, municipal workers, environmental health scientists - work to keep us healthy.

It’s not always easy. Michael Yudell, Jonathan Purtle, and other contributors tell you why.

Michael Yudell, PhD, MPH Associate Professor, Drexel University School of Public Health
Jonathan Purtle, DrPH, MSc Assistant Professor, Drexel University School of Public Health
Janet Golden, PhD Professor of history, Rutgers University-Camden
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