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From Health Law Daily, April 5, 2013

Federal judge orders FDA to make emergency contraception available over-the-counter to women of all ages

By Danielle H. Capilla, JD

A federal judge in the Eastern District of New York has reversed the FDA’s denial of a Citizen Petition (petition) regarding access to emergency contraception and ordered the FDA to grant the petition and make levonorgestrel-based emergency contraceptives (emergency contraceptives) available over-the-counter (OTC) and without age restrictions (Tummino v Hamburg, April 4, 2013, Korman, E).The order gives the FDA the ability to determine if any new labeling is necessary but specifically prohibits the FDA from “administrative agency filibuster” by commencing the administrative rulemaking process. The FDA is also permitted to limit OTC access to the one pill product if it determines it is significantly different from the two pill product that is also available. The court also denied Teva Women’s Health Inc.’s (Teva) motion to intervene for the limited purpose of defending its statutory right to marketing exclusivity and instead granted Teva amicus curiae status.

Background. Emergency contraception, also known as the “morning after pill,” was first available as a prescription-only drug in the United States in 1999. In 2001, a Citizen Petition was filed seeking to expand the drug’s availability to women of all ages as an OTC drug, which the FDA denied in 2006. Shortly thereafter the FDA approved the drug for OTC access to women who were 18 and older, and with a prescription for women under the age of 18. In the lawsuit that followed, the Eastern District of New York found in 2009 the FDA was bowing to political pressure and ordered the agency to re-evaluate the citizen petition and to make emergency contraception available OTC to women 17 years of age and older. The agency reevaluated the citizen petition and in 2011 it agreed to approve an emergency contraceptive manufacturer’s supplemental new drug application (SNDA) to make the drug available OTC to women of all ages. Shortly thereafter Secretary Sebelius, the Secretary of Health and Human Services (the Secretary), invoked her authority to overrule the agency and, supported by President Obama, prohibited the approval of the SNDA, stating that significant cognitive and behavioral differences between older adolescent women and females of the youngest reproductive age necessitated age limitations. Days after this determination, the FDA denied the Citizen Petition for the second time, on the eve of the scheduled contempt hearing for the agency’s failure to rule on the petition per the 2009 court order. In the immediate case, the court now rules on the denial of the petition.

Citizen Petition. Despite the lengthy procedural and political history regarding the availability of the morning after pill, the instant case looks only to the Citizen Petition which was filed in 2001 seeking to make emergency contraception available to women of all ages over-the-counter. However, because the FDA’s second denial of the petition relied heavily on the Secretary’s denial of the SNDA, the Secretary’s decision was also considered, insofar as it influenced the petition denial. The court found the Secretary’s overruling of the FDA’s decision to approve the SNDA to be arbitrary, capricious, and unreasonable due to its political motivations, scientifically unjustified reasoning, and its conflict with prior FDA precedent. The court noted that the job qualifications for Commissioner of the FDA (who originally approved the SNDA) and those of the Secretary are not the same, and that the Secretary did not have the scientific background necessary to properly deny the SNDA.

Conflict with FDA precedent. The court relied heavily on the FDA’s prior decisions to allow two drugs that were found to be unsafe for adolescents—one for heartburn and one for weight loss—to be sold over-the-counter, without being placed behind a pharmacy counter or requiring point of sale identification checks. Instead, these drugs note on the label that they are for use in individuals over the age of 18. Comparatively, emergency contraception has been shown to be a very safe drug, and according to the court, is only controversial due to its potential access by young individuals who should not be engaging in conduct necessitating its use, and due to unsupported arguments it can prevent a fertilized egg from implanting. The Secretary’s denial of the SNDA and the FDA’s denial of the petition was a clear deviation from its prior policy. The court also noted the FDA did not have authority to require drugs to be sold over-the-counter but placed behind the pharmacy counter, as there was no special subclass of drugs that necessitated this security. This point of sale placement effectively limited access to the drug, which is not appropriate for an OTC drug.

Use of studies. In its denial letter, the FDA wrote that the petitioners failed to provide adequate labeling and actual use studies showing that women under the age of 17 would comprehend the label and proper use of the drug, while acknowledging that the drug manufacturer that submitted the SNDA for OTC use of the drug provided such studies. The FDA also acknowledged it delayed its reconsideration of the petition for three years as it anticipated the SNDA studies would be relevant in order to determine if OTC use was appropriate. The court found this conflict unacceptable, noting that it was another example of the FDA’s bad faith in the denial of the petition.

Ruling. The court reversed the FDA’s denial of the petition and ordered the FDA to grant the petition and make emergency contraceptives available OTC without age or point of sale restriction. The court also noted there was considerable the bad faith in the FDA’s earlier decision, along with intolerable delay in processing the decision, as the original petition was filed more than 12 years ago. In forbidding the FDA to engage in any rulemaking procedures or public comment prior to granting the petition, the court held “the plaintiffs 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.”

The case number is 12-CV-763 (ERK)(VVP).

Attorneys: Janet Crepps (Center for Reproductive Rights) for Association of Reproductive Health Professionals, National Latina Institute for Reproductive Health. Farzin Franklin Amanat, United States Attorney’s Office, for Margaret Hamburg, Commissioner, Food and Drug Administration. Eric B. Beckenhauer, United States Attorney’s Office, for Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services.

Companies: Association of Reproductive Health Professionals; National Latina Institute for Reproductive Health; Food and Drug Administration; United States Department of Health and Human Services

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