April 10, 2013
The Eastern District of New York last week held that Plan B, an emergency contraceptive drug, should be available, over the counter, and without age restrictions to women and girls. Tummino v. Hamburg, 12-CV-763 ERK VVP, 2013 WL 1348656 (E.D.N.Y. Apr. 5, 2013) involves plaintiff organizations and individuals who sought to expand availability of emergency contraceptives to women and girls. They sued in 2005 in response to a denial by the F.D.A. of a Citizen Petition seeking over-the-counter access to Plan B. The court previously vacated that denial and directed the FDA to make Plan B available to 17 year-old adolescents without a prescription. The previous decision declined to go further at the time. In the meantime, the FDA, finishing their review, determined that one type of emergency contraceptive, Plan B One-Step, should be made available to women and girls, with no age restrictions, and without a prescription. Despite this recommendation, Secretary of Health and Human Services, Kathleen Sebelius, disagreed with this recommendation and decided to not allow the drug to be sold without point of sale or age restrictions. Sebelius expressed concern that an 11 year old girl could gain access to the product, and indicated that the studies failed to include data on all ages of potential users.
The court vehemently disagreed with Sebelius’ decision, noting that her implication that an 11 year-old girl could suffer adverse consequences was just an excuse to restrict women’s access to contraceptives. The court aggressively criticized the decision as politically motivated, and not related to any legitimate safety concerns. In fact, despite the Secretary’s expressed concern over the drug being made available to very young women and girls, the court notes that studies have proven that the emergency contraceptives at issue would be one of the safest drugs available over the counter for the pediatric population. The court noted that traditionally, the FDA has utilized age-based labeling restrictions to address such concerns. Also mentioned was the unlikelihood that emergency contraceptive drugs would be abused, especially in comparison to other drugs available over-the-counter widely known to be abused or misused. In addressing the question as to whether girls of child bearing age under the age of 17 should be allowed over-the-counter access, the court notes that there is evidence supporting older adolescents ability to understand the drug’s labeling and use it correctly, and that restrictions for those under the age of 13 would result in complete denial of access, since younger adolescents typically do not have identification available to verify their age. Point of sale restrictions were deemed arbitrary, since even “riskier” drugs were not burdened with similar restrictions, and Plan B has been established as being safe and effective for use even in the pediatric population.
Applying the standard of review set forth by the Administrative Procedure Act (APA), the court held that the FDA had arbitrarily and capriciously deviated away from its own policy when denying the Citizen’s Petition, and allowing the Sebelius’ decision to influence their own. They also ruled that the FDA lacked authority to require point-of-sale restrictions where the drug was approved for nonprescription sale and determined to be safe and effective for all women of childbearing age.
You can check out the history of the Tummino case by clicking on the “History” tab when viewing the case on WestlawNext. The “History” tab lays out the direct history of the case in graphical format.
There are also a number of filings available for this case. We see 55 Trial court Documents available, and a number of expert court documents available, including expert depositions, affidavits and reports.
Of course, we won’t necessarily find analysis of this particular decision in secondary materials quite yet, because we know this litigation has an extensive history, we can check out secondary sources that may have mentioned the case generally, or related decisions.
adv: tummino and hamburg
We pull back 10 results in Secondary Sources with that query, including articles discussing judicial review of FDA rules, articles discussing FDA regulations generally, and articles discussing Plan B and related regulation and litigation.