Last December, the Obama Administration overruled a previous FDA decision regarding the availability of the emergency contraceptive Plan B One-Step, in what has since become a controversial intervention, according to an article in the New York Times. This has subsequently caused a public split between two interested parties that were expected to have similar opinions on the issue.
The Commissioner of the U.S. Food and Drug Administration (FDA), Margaret Hamburg, M.D., in her statement responding to the overrule, explained the drug’s history and preceding legislation. In her statement, Commissioner Hamburg explains the science behind the pill: Plan B One-Step is an emergency contraceptive that effectively decreases the chance of pregnancy if taken within three days of unprotected sexual intercourse. It is a single-dose pill that contains 1.5 mg of levonorgestrel, a higher dose of hormone than is contained in some daily use oral hormonal contraceptives. Commonly known as the “morning after” pill, it works in a way similar to daily birth control pills.
According to Hamburg’s statement, the drug was previously approved in July 2009 to be made available without prescription for females age 17 and older and as a “prescription-only option” for girls younger than 17. In this statement, she also explains the context leading up to the FDA overrule. In February 2011, a supplemental new drug application submitted to the FDA by Teva Women’s Health Inc., the company that produces Plan B Oral One-Step, advocated for removing the prescription requirement for girls younger than age 17, effectively making Plan B One-Step available as a non-prescription drug for all females of reproductive age, with no age restriction.
On December 7, 2011, Kathleen Sebelius, President Obama’s Secretary of Health and Human Services, issued a press release and addressed a separate memorandum to Commissioner Hamburg of the FDA. This memorandum effectively overturned the FDA’s approval of Teva’s efforts to “market its Plan B Oral One-Step as a non-prescription drug product without any age restriction.” As outlined in an article in the New York Times, President Obama has come forward with a statement that while he fully supports Sibelius’ actions, he was not involved in the actual decision-making. Echoing Sibelius, the article outlines Obama’s argument that a “10-year-old or 11-year-old” should not have access to “medication that potentially, if not used properly, could have an adverse [health] effect,” adding that he believes “most parents probably feel the same way.”
The Center for Drug Evaluation and Research (CDER), in its review of the drug application and its scientific determination, determined that the drug meets the regulatory standard for over-the-counter drugs and that “Plan B One-Step should be approved for all females of child-bearing potential,” according to Commissioner Hamburg’s statement. She states that this conclusion was derived from a risk/benefit analysis common to the CDER’s drug review process, the decision reflects scientific research on the drug, contribution from external scientific advisory committees, and data from studies of the non-prescription regulatory standard. In her commissioner statement in response to Secretary Sibelius’ decision against the approval, Commissioner Hamburg of the FDA supports CDER’s finding that there is “adequate and reasonable, well-supported” scientific evidence for the drug’s safety and effectiveness when applied appropriately.
The science was not the issue for Secretary Sebelius, who rejected the proposal mainly due to reasons surrounding use of the drug. She acknowledges the scientific certainty of the FDA that the “drug [is] safe and effective with appropriate use,” as outlined in her statement. However, she indicates in her statement that the transition of the drug to an over-the-counter product “requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately.” She states in the same statement that the data used by the FDA (such as actual use studies) “do not include data on all ages” that the drug would be approved for. Secretary Sibelius further argues that there are “significant cognitive and behavioural differences between older adolescent girls and the youngest girls of reproductive age” in her memorandum. She claims this should be considered in the decision to make the drug available to all girls, even those that reach child-bearing potential by age 11.1, the lowest threshold age for child-bearing ability (12.4 years being the average.) She notes that her decision does not change the status quo regarding how the drug is being offered presently.
Sibelius’ actions have been met with much negative feedback from the medical and scientific communities, as well as from supporters of women’s rights, who view the availability of the drug without mandated prescription as a means to empower girls of all ages, in terms of their reproductive rights. Similarly, many have raised concerns with President Obama’s lack of involvement in the affair and interpreted his actions as politically motivated. His strong support of Sibelius is accepted by those for the proposed legislation while his lack of action in the decision-making process is endorsed by those against.
Erin Matson, the Vice-President of the National Organization for Women, currently the largest feminist advocacy group in the United States, advocates for those criticizing the decision and Obama’s comments through an opinion piece for her organization’s blog. Matson sees the President’s lack of involvement as a means to be distant enough from the affair to “have [Sibelius] take the fall” for the outrage from various contingencies in the community. She argues that Obama and Sebelius’ arguments have no medical evidence to offer against the scientifically based opinion established by the CDER and the FDA concerning the health effects of Plan B on girls of all ages. Matson believes that the “administration’s overreach” into a woman’s right to “reproductive justice”—which, in Matson’s opinion, should not be granted to any individual other than the woman seeking contraceptives herself—can negatively affect teenage women beyond the 10-11-year-old demographic. Although the arguments against the legislation are concerned with the youngest of the targeted demographic for the drug, Matson believes that older teens will be adversely affected by having their access to over-the-counter Plan B denied as well. She strongly states her views that the Obama Administration, in voicing its concerns for young teens’ health, “prey[s] on fears about pre-teen youth and sexuality” and denies the entire demographic’s—including older teens—access to medication that is appropriate for them. Matson echoes many in the camp that stand against this decision, stating that the political choices will affect women’s “fundamental right to self-determination.” According to her opinion piece, the prescription mandate is seen by many as potentially damaging to those who cannot obtain a prescription due to logistical issues in an emergency.
From the opposite end of the debate, Michael Tomasky offers an alternative interpretation of Sibelius’ decision in an article in the Daily Beast. He points out that Sibelius’ key point through her statement was not a focus on the health risk in younger girls and proper intake but rather the “ethical and moral questions about what is the proper age for access to emergency contraception.” He argues that “in an ideal world,” parents would be supportive of children acquiring emergency contraception after the event of an undesired potential pregnancy. In his article, Tomasky insists that because parents “don’t always think rationally about these things,” these issues become sensitive and off-bounds to the state’s intervention. He believes that it is “hardly illegitimate” for the government to consider the guardian or family’s say in these private matters into their legislation. Furthermore, Tomasky points to the Obama administration’s new policy last August—in which insurance companies will be required to cover all expenses from government-approved contraceptives with no additional fees beginning January 2013—as evidence that they’re far from being “anti-woman” as labelled by many critics of the Plan B decision. He urges for a reconsideration of the timing of this legislation and the general public’s readiness for it, instead of debating the finer points of the safety and technicality surrounding the medication, arguing for “a longer debate about the appropriate age at which this pill should become available.” In his article, this decision catalyzes a need for “the culture to catch up with the science” and not the other way around.
Obama’s move—or the lack of firm agency in this decision from someone in his administration—does indeed have important political implications, whether or not that was his intention. However, Sibelius’ decision and its subsequent controversy is merely one part of the larger battle between the state’s role in ensuring public safety and the individual’s right to personal reproductive liberty. In the mean time, President Obama’s decision to remain in the background on this contentious issue and its subsequent effect on the public’s views of his position on women’s rights issues remains to be seen.
References:
Harris, G. Plan to Widen Availability of Morning-After Pill is Rejected. The New York Times. Available at: http://www.nytimes.com/2011/12/08/health/policy/sebelius-overrules-fda-on-freer-sale-of-emergency-contraceptives.html. Accessed February 11, 2012.
United States Food and Drug Administration. Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step. Washington, D.C.: United States Food and Drug Administration; 2011.
The Secretary of Health and Human Services. MEMORANDUM: Supplemental New Drug Application. Washington, D.C.: United States Department of Health and Human Services; 2011.
Landler, M. Obama Backs Limit on Sale to Teenagers of Morning-After Pill. The New York Times. Available at: http://www.nytimes.com/2011/12/09/us/politics/obama-expresses-support-for-plan-b-decision.html. Accessed February 11, 2012.
United States Department of Health and Human Services. A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius. Washington, D.C.: United States Department of Health and Human Services; 2011.
Matson, E. Why President Obama’s Statements on Emergency Contraception Make Things Worse. Say It, Sister! NOW Blog for Equality. 2011. Available at: http://www.now.org/news/blogs/index.php/sayit/2011/12/08/why-president-obama-s-statements-on-emergency-contraception-make-things-worse. Accessed February 11, 2012.
Tomasky, M. A Progressive Defense of the White House on Plan B. The Daily Beast. 2011. Available at: http://www.thedailybeast.com/articles/2011/12/09/michael-tomasky-a-progressive-defense-of-the-white-house-on-plan-b.html. Accessed February 11, 2012
