When President Obama lifted federal restrictions on embryonic stem cell research early in his administration, he set a markedly different tone from that of the Bush years, declaring that scientific decisions should be “based on facts, not ideology.”
Nearly three years later, Obama has left many public health experts demoralized after his Secretary of Health and Human Services, Kathleen Sebelius, unilaterally overruled a recommendation by the Food and Drug Administration to make the Plan B emergency contraceptive, otherwise known as the “morning-after pill,” available to women under the age of 17 without a prescription. Currently, teenagers who are 16 and under need a prescription to obtain the pill, a requirement that will remain in place under Sebelius’s decision. This is the first time a health secretary has ever publicly rejected a finding by the FDA.
In a statement, FDA commissioner Margaret Hamburg said she agreed with the results of an internal study conducted by the Center for Drug Evaluation and Research – the culmination of nearly a decade of research on emergency contraception conducted by both federal agencies and independent medical experts — that found that Plan B should be made available to females under the age of 17 without a prescription.
“I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” Hamburg said.
In her own statement, Sebelius offered only a vague justification for her rejection of the FDA’s finding. She acknowledged that “the science has confirmed the drug to be safe and effective,” but suggested that it was unclear whether teens under the age of 17 could fully understand the instructions.
“The switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately,” Sebelius said, referring to the company that submitted the application, Teva Women’s Health, Inc. “I do not believe that Teva’s application met that standard.”
Critics pounced on the statement, accusing the Obama administration of caving to political pressure from social conservatives who say the availability of emergency contraception encourages sexual activity among teens. Nancy Keenan, president of NARAL Pro-Choice America, noted that institutions such as the American Academy for Pediatrics (AAP) had recommended making Plan B available to women of all ages. “The Obama administration has broken a key promise to the American people that it would base its decisions on sound science and what’s in the best interest of women’s health,” Keenan said.
Indeed, as many observers said, it’s difficult to see the Obama administration’s decision on Plan B as anything other than a political maneuver, given that the overwhelming weight of scientific evidence, and the consensus in the medical community, suggested that Plan B could help significantly reduce teen pregnancy rates and should be available to women of all child-bearing ages.
Medical experts have for years urged the federal government to make emergency contraception available to teens without a prescription, noting that the drug is safe and highly effective, preventing as much as 80 percent of pregnancies in teens and young women, according to the AAP. As early as 2005, the Academy wrote in a policy statement, “Reduction of unintended pregnancy during adolescence and the associated negative consequences of early pregnancy and early childbearing remain public health concerns. Emergency contraception has the potential to significantly reduce teen-pregnancy rates.”
The AAP also found no evidence that the availability of emergency contraception increases rates of sexual activity, or the frequency of unprotected sex, among teens. Studies in which a treatment group was given an advanced provision of emergency contraception and a control group was given only education found that ”there were no differences in the frequency of unprotected sex between the groups,” according to the AAP.
Statistics compiled by the Guttmacher Institute, which works to advance sexual and reproductive health, show that there are roughly 750,000 teen pregnancies in the United States every year, and the rate of teen pregnancy in the U.S. remains one of the highest in the developed world. There has been a steady decline in teen pregnancy rates since the 1990s, but, as the Guttmacher Institute noted, medical experts have attributed the bulk of that decline to “teens’ increasingly consistent contraceptive use.”
There’s also a case to be made that wider availability of Plan B emergency contraception could help lower the rate of teen pregnancies that end in abortion, experts say. According to the Guttmacher Institute’s numbers, 82 percent of teen pregnancies in the U.S. are unplanned, and nearly a third — 27 percent — end in abortion. As Keenan, of NARAL Pro-Choice America, put it, “We had a major opportunity to improve young women’s access to contraception, which is the best way to reduce the need for abortion, and the Obama administration missed the mark.”