The politics surrounding women’s reproductive health is bizarre.
The Republican Party has committed itself to legislatively controlling women’s bodies. So much for “small” government. It has focused relentlessly on passing (blatantly unconstitutional) abortion bans and generally doing whatever else it can to limit women’s reproductive freedom. These actions have fed into the narrative that the Party is anti-science – i.e., willing to throw science under the bus for any number of pet ideological causes. The Democratic Party, in contrast, is often perceived as the true champions of science in America. But this characterization is undeserved. Democrats, including President Obama, have demonstrated profound ignorance and political cowardice concerning women’s reproductive rights. The Obama Administration’s decision to overrule the FDA’s ruling making emergency contraceptives available to everyone, regardless of age, is a recent example of this disturbing trend in American politics. But thankfully, last friday a federal judge appointed by Ronald Reagan saved America’s teens from the stupidity of its elected officials.
First, some background. And some science.
Plan B and Plan B One-Step are emergency contraceptives that can be taken to reduce the risk of pregnancy after intercourse. Although Plan B is no longer marketed, generic versions of levonorgestrel, the active ingredient in Plan B, are available. According to the Government Accountability Office (GAO), levonorgestrel “interferes with prefertilization events. It reduces the number of sperm cells in the uterine cavity, immobilizes sperm, and impedes further passage of sperm cells into the uterine cavity. In addition, levonorgestrel has the capacity to delay or prevent ovulation from occurring.” It has no known serious or long-term side-effects, though there may be some mild mid or short-term side effects (e.g., nausea, fatigue, and headache).
What levonorgestrel is decidedly not, however, is an “abortion pill.” Pro-life organizations, such as the Texas Right to Life, have long argued that emergency contraceptives “are not birth control, but the abortion pill in disguise.” However, as noted by the GAO, contraceptives using levonorgestrel “have not been shown to cause a postfertilization event.” In other words, levonorgestrel does not interfere with the implantation of a fertilized egg. Therefore, it cannot possibly induce an “abortion.”
In 2011, FDA agreed to allow over-the-counter access to Plan B for all ages. FDA Commissioner Margaret Hamburg detailed FDA’s rationale in a statement on December 7, 2011. Commissioner Hamburg recognized that “It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.” And after careful review, FDA concluded 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.”
In an unprecedented move, however, Secretary of Health and Human Services Kathleen Sebelius overruled FDA. Specifically, Secretary Sebelius concluded “that the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages.” President Obama endorsed this decision, explaining that “the reason [Secretary Sebelius] made this decision was she could not be confident that a 10-year old or an 11-year old go into a drugstore, should be able – alongside bubble gum or batteries – be able to buy medication that potentially, if not used properly, could end up having an adverse effect.” This was not, it should be noted, the first time President Obama embraced scientific illiteracy.
On the campaign trail in 2008, Obama made common cause with people who think vaccines caused autism. Obama said, “We’ve seen just a skyrocketing autism rate. Some people are suspicious that it’s connected to the vaccines. This person included. The science right now is inconclusive, but we have to research it.” There is no truth whatsoever to that statement, reflecting the opinion of either a severely uninformed individual or someone who is playing politics with people’s fears. Rather, the science has been settled since 2002. There is, in fact, no relationship between vaccines and autism rates in children.
Nevertheless, the motivation behind Secretary Sebelius’ action was obviously political. Gardner Harris at the New York Times noted that the Secretary’s action “was the first time a cabinet member had ever publicly countermanded a determination by the F.D.A.” and recognized that it was an election-year decision that “many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.” Similarly, scientists in the New England Journal of Medicine wrote:
In our opinion, the secretary’s decision to retain behind-the-counter status for Plan B One-Step was based on politics rather than science. It cannot be based on issues of safety, since a 12-year old can purchase a lethal dose of acetaminophen in any pharmacy for about $11, no questions asked. The only documented adverse effects of a $50 dose of levonorgestrel are nausea and delay of menses by several days. Any objective review makes it clear that Plan B is more dangerous to politicians than to adolescent girls.
In his stinging opinion last Friday, Judge Korman recognized that emergency contraception is “among the safest drugs sold over-the-counter” and that there is no reason to deny it to younger women. To do so would be to hold emergency contraception to a different standard than other drugs commercially available in the United States. But, as Judge Korman acknowledged,
The standards are the same for aspiring and for contraceptives. While the FDA properly recognizes that cognitive and behavioral differences undermine “the ability of adolescents to make reasoned decision about engaging in sexual intercourse,” the standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug “safely and effectively.”
When analyzed in accordance with the appropriate legal standard, the decisions of Secretary Sebelius “were arbitrary, capricious, and unreasonable.” The Obama administration, Judge Korman wrote, had acted in “bad faith,” and Secretary Sebelius acted in a way that “was politically motivated, scientifically unjustified, and contrary to agency precedent.” And in a direct challenge to President Obama, Judge Korman wrote that “The invocation of the adverse effect of Plan B on 11-year olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”
The Second Circuit’s decision orders the FDA to make levonorgestrel-based emergency contraception available without age restrictions within 30 days because, as Judge Korman wrote, women “should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.” If the Obama administration chooses not to appeal the decision, and it should not, this ruling will remain the law of the land.
Early on in his first term, President Obama promised that his administration would make “scientific decisions based on facts, not ideology.” His administration’s decision to overrule the FDA reflected a failure to live up to this promise. It was an indefensible act of political cowardice, and it is shameful that it had to come to this. Still, better late than never.