JURIST Guest Columnist Andrea Miller, University of Minnesota Law School Class of 2015, explains how Judge Korman’s decision in Tummino v. Hamburg creates solid policy and legal precedent…

US District Judge Edward Korman recently brought some much-needed closure to a 12-year legal debate over the regulatory status of emergency contraception (EC or what many call the “morning after” pill). The Food and Drug Administration (FDA) has spent those 12 years trying to avoid transferring EC from prescription-only to over-the-counter status. In 2011, the FDA finally agreed to allow women and girls of any age to access EC over the counter, but Secretary of Health and Human Services Kathleen Sebelius stepped in and overruled the FDA’s decision. In Tummino v. Hamburg [PDF], Judge Korman struck down Sebelius’ ruling, which would have maintained the onerous requirement that girls under 17 have a prescription for EC. He concluded [PDF] that “it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.”

On June 10, 2013, the federal government announced that it would drop its appeal of the decision. Some have criticized the court’s ruling and urged the government to fight it. Many others recognize that continuing to defend age restrictions on access to EC is a losing battle that only harms women and girls who need access to birth control.

As a matter of justice, Judge Korman made the right decision. Women and girls must have control of their bodies and their sexuality if they are to be autonomous, full-fledged members of society.

As a matter of policy, widespread access to emergency birth control is desperately needed. EC is most effective during the first 24 hours [PDF] after sexual intercourse, and can be taken up to 72 hours afterward. With such a short time window, any delay in a woman’s access to EC can make the difference between preventing a pregnancy or not. Before Korman’s ruling, girls under 17 were required to get a prescription for the drug. For girls who were too young to drive, did not have their parents’ permission to go to a doctor, or experienced sexual abuse by the very people who could get them to a doctor, the prescription requirement made access to EC very difficult in practice. Furthermore, the age restriction meant that even women and girls who were older than 17 needed to show a government-issued ID to prove their age. This made access to EC difficult for women who did not have driver’s licenses or passports (who were also more likely to have low incomes and lack convenient transportation). Finally, researchers discovered that it often takes multiple pharmacy trips to find EC&151#; some pharmacists either refuse to stock the drug or lie about whether customers can legally access it. Together, these factors create huge obstacles for women and girls who need to prevent a pregnancy and do not have very much time to do so. Judge Korman’s ruling takes a big step toward eliminating these barriers.

Political matters aside, however, Judge Korman’s opinion is actually a gem of legal analysis and decision-making. While the ruling represents a major step forward in emergency contraception policy, and is a huge victory for women’s rights, it manages to be judicially restrained and narrow in scope.

First, Judge Korman took a complicated issue and rooted out the messy political factors that threaten a coherent legal discussion about emergency contraception. It is a difficult conversation to have in a public forum. Many people are uncomfortable with the idea of young teenagers having sex or being sexually assaulted, and that is understandable. Further complicating the discussion [PDF] is the fact that opponents of emergency contraception sometimes falsely associate EC with abortion or falsely imply that the drug is harmful to women or their future babies.

Research studies have demonstrated that all of these claims are unfounded myths. However, they inevitably appear in discussions of EC, and Judge Korman artfully dug his way through the political quagmire and homed in on the issue at hand in Tummino. As he put it [PDF], “the issue in this case involves the interpretation of a general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale. The standards are the same for aspirin and for contraceptives.”

Second, the Tummino decision is judicially restrained. The crux of the holding is that the FDA must either follow its own procedures, or have a rational explanation when it deviates from its procedures. The case turns on a provision of the Administrative Procedure Act that allows a court to overturn a federal agency decision that is “arbitrary, capricious,” or “an abuse of discretion.” Previous courts have interpreted this statute to mean that when an agency deviates from its own policies and procedures without a rational explanation, the agency’s decision becomes a strong candidate for being overturned.

In this case, the evidence of the FDA’s departure from its own policies is staggering. The FDA concluded, based on a large body of scientific evidence, that Plan B (a particular brand of EC) was safe for women and girls, and that customers could be trusted to follow the directions and take the drug safely without a doctor’s supervision. In fact, Plan B has been shown to be safer [PDF] than acetaminophen, laxatives, cough syrups, and heartburn medication, all of which are sold over the counter without age restrictions. The only side effects are nausea and the delay of menstruation by a few days. In spite of all of this evidence, the FDA denied the application to make Plan B available over the counter, based on Secretary Sebelius’ ruling.

Other deviations from agency policy include [PDF] the fact that Sebelius refused to extrapolate the usage data from older teenagers and apply it to younger teenagers (which the FDA does regularly). The FDA also ignored [PDF] the recommendations of its own advisory committee, which voted 23-4 to approve over-the-counter status. Furthermore, in cases where a drug is actually shown to be unsafe for certain ages, the FDA typically uses the product label [PDF] to warn consumers that it should only be used by people of certain ages—it does not put the drug behind the counter and require an ID. Finally, the FDA usually does not create [PDF] dual marketing systems under which the drug is prescription-only for some ages and over-the-counter for others — drugs either require a prescription or they don’t.

Given this body of evidence, Judge Korman had almost no choice but to find [PDF] that the denial of over-the-counter status for Plan B was “arbitrary, capricious, and unreasonable.” Despite the fact that he overturned the FDA’s decision, his ruling is actually quite narrow and restrained. He does not question the FDA’s policies or how the FDA gathers and uses evidence. He also does not impose his own evaluation of the evidence on the agency. He simply demands that the FDA follow the policies and procedures that it created for itself and adopt the decision that it originally made before Sebelius intervened. Tummino’s legal legacy is the simple requirement that agencies work reasonably consistently within their own procedures—a very modest request from the courts.

Third, the Tummino decision reaffirms the purpose of the FDA. The FDA is supposed to make its decisions based on science. To fulfill its purpose, the agency must be free from political influence. Of course, some amount of values will enter the government’s decision-making about some drugs, and that may be a good thing [PDF]. But the government must prioritize the use of empirical data [PDF] and should not ignore the results of data that it has collected, simply because the findings are politically inconvenient. Judge Korman noted that the Secretary of Health and Human Services rarely has technical or scientific training, while the Commissioner of the FDA must be qualified [PDF] to deal with scientific data. In fact, Congress altered [PDF] the job description of the Commissioner in 1988 so that he or she would no longer serve at the pleasure of the Secretary. Congress made this change because it recognized that leading the FDA requires scientific expertise and insulation from political pressure.

In this case, the FDA has allowed the over-the-counter application for Plan B to languish for 12 years, amounting to [PDF] “an administrative agency filibuster.” The FDA has also used Plan B as a political football in its relationship with presidents and their cabinets. Sebelius’ ruling was the first time a cabinet member has ever dared to overrule a determination by the FDA. It occurred during a presidential election and was an obvious effort on the part of the Democratic Party to “avoid riling religious groups.” Judge Korman’s decision is important because it holds both the Secretary and the FDA accountable for allowing important FDA decisions to be politically tainted.

All in all, the decision in Tummino v. Hamburg is good for both policy and legal precedent. The ruling protects the fundamental right of women and girls to control their own reproductive choices. It also manages to be judicially restrained and narrow in its scope. Despite the fact that the decision overturns an action by the FDA, it is actually quite deferential to the agency. It merely requires that the FDA follow its own procedures and operate free from political pressure by the president’s cabinet. Even those who oppose emergency contraception should be comforted by the fact that the courts will require the FDA to make policy decisions based on scientific evidence, unaffected by which party happens to be in office.

Andrea Miller is the co-president of Law Students for Reproductive Justice at University of Minnesota Law School. Her experience includes positions with Gender Justice, Criminal Justice League Expungement Workshops, and Minnesota Women Lawyers. Miller is also pursuing her Ph.D. in social psychology.

Suggested citation: Andrea Miller, Increased Access to Emergency Contraception in Tummino is Good Policy and Good Precedent, JURIST – Dateline, July 12, 2013, http://jurist.org/dateline/2013/07/andrea-miller-womens-rights.