The Obama administration’s secretary of Health and Human Services (HHS) has overruled a Food and Drug Administration (FDA) recommendation that would have allowed emergency contraceptives to be sold over the counter with no age restrictions. The move is an affront to women’s reproductive rights and an attack on the health of young women.
It is an action without precedent and the first time that HHS has used its statutory authority to override a government agency recommendation. Obama personally defended the decision in remarks at a White House press conference on Thursday.
The decision, denounced by women’s health advocates and medical professionals, highlights the Obama administration’s pandering to the religious right, anti-abortion activists and the Catholic Church.
The move will keep in place restrictions requiring women 16 and younger to have a doctor’s prescription before obtaining Plan B One-Step, an emergency contraceptive pill produced by Teva Pharmaceuticals. Women 17 and older will continue to be able to purchase the drug over the counter (OTC).
In a statement Wednesday, HHS Secretary Kathleen Sebelius said, “After careful consideration of the FDA summary review, I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over-the-counter for all girls of reproductive age.”
Secretary Sebelius claimed that women 16 and younger may not have the ability to understand instructions and take the pill properly without adult supervision. She also argued that because 10 percent of 11-year-old girls can bear children, this specific age group needed to be studied. In fact, the research compiled by the FDA on Plan B OTC usage included two studies, one involving girls 12 to 17 and one of girls 11 to 16.
In his remarks on Thursday, Obama defended his HHS secretary’s decision to block over-the-counter sales of Plan B for women younger than 17. Claiming, “I did not get involved in the process,” he said 10-and 11-year-olds should not be able to buy the drug “alongside bubble gum or batteries,” and that “it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.”
In reality, both common sense and scientific research come down on the side of lifting the age restrictions. A dose of the drug consists of one 1.5 milligram pill of a synthetic version of the female hormone progesterone, a medication that has been used in birth control pills for decades. Supporters of easing age restrictions note that the relatively expensive cost of the drug—$35 to $50 a pill—would serve as an impediment to using it multiple times a month, or purchasing multiple doses.
Critics of the Obama administration’s decision point out that a multitude of drugs available have far more potential side effects than Plan B and are lethal when overdosed, yet they are available without a prescription to people of all ages. The most serious common side effect of Plan B, on the other hand, is nausea lasting several hours.
Former FDA assistant commissioner Dr. Susan Wood commented to the New York Times, “Acetaminophen can be fatal, but it’s available to everyone. So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?” Dr. Wood resigned her FDA position in protest over Bush administration efforts to block Plan B.
Plan B is most effective when used as soon as possible after unprotected sex, preferably within 72 hours. For a number of reasons, requiring young women to obtain a prescription will only serve to delay timely access of the drug. They may not have a physician or may not be able to get an appointment. They may also be unwilling to speak to their parents about their sexual activity. In the worst case, a young girl may seek out the emergency contraception after being raped.
Opponents of lifting age restrictions on Plan B argue that this would promote sexual promiscuity among young adolescents, a contention that has no basis in scientific research. One representatively ignorant comment came from Jeanne Monahan, director of Family Research Council’s Center for Human Dignity, who said allowing the sales of Plan B without prescription “would not have been in the interest of young women’s health” and making the drug readily available could subject girls to sexual abuse and exploitation, as they could be given the drug under coercion.
What has been scientifically established is that women who have unprotected intercourse have about one chance in 20 of becoming pregnant, and that women who take Plan B within three days halve that risk to one in 40. A surgical abortion as a result of an unintended pregnancy poses far more medical complications than the emergency contraceptive.
But opponents of Plan B do not base their arguments solely on their puritanical outlook. The drug’s principal effect is to prevent ovulation, but it also may make the lining of the uterus less receptive to a fertilized egg, an effect common to all hormonal and intrauterine contraceptives. Anti-abortion zealots who contend that life “starts with conception” designate Plan B as an “abortion pill.” Thus they are opposed to the use of Plan B by women of any age, and would prefer that they endure unwanted pregnancy, with the substantial medical risk this entails, particularly for the youngest women.
The Obama administration’s support for blocking over-the-counter access to Plan B for young women is a move calculated to build support among such backward political forces in his bid for reelection. It is an effort to balance his populist posture as a fighter for social equality and defender of the “middle class” with the interests he truly represents—the financial elite and political establishment.
Obama is also utilizing the Plan B issue to counter criticism from the Catholic Church and other right-wing forces of one of the minimal reforms contained in his health care legislation—a requirement that insurance programs created under the law offer contraceptives for free.
Over the past decade, dozens of medical organizations, including the Union of Concerned Scientists, the Center for Drug Evaluation and Research and the American Academy of Pediatrics have endorsed moving emergency contraception to drug store shelves. The bulk of the Food and Drug Administration’s review committee have also recommended easing the restrictions on access to Plan B.
The Bush administration attempted to block over-the-counter availability of the drug for women of any age, but finally allowed it for women 18 and older. The Obama administration lowered the age to 17 in 2009, following a federal court order.
After assuming office in 2009, Obama signed a Presidential Memorandum on Scientific Integrity, promising to restore “scientific integrity to government decision-making.” Obama’s support for blocking ready access to emergency contraception is a demonstration that the administration is willing to ditch sound science and the basic rights of young women in the interest of political expediency and kowtowing to right-wing forces.