12.31.11

Lawsuit Offers Hope that the Plan B OTC Age Restrictions may yet be Lifted

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The fight to make Plan B, an emergency contraceptive, more widely available continues despite Health and Human Services Secretary, Kathleen Sebelius’ decision earlier this month to overrule the FDA’s recommendation that Plan B be made available over-the-counter (OTC) to women and girls of all ages. The Center for Reproductive Rights (CRR) will reopen a lawsuit, Tummino v. Hamburg, originally filed in 2005 in response to the FDA’s denial of a citizen’s petition to make Plan B available OTC to women of all ages. According to the complaint filed by CRR at the time the FDA’s decision was “not supported by medical or scientific evidence.”

The battle over OTC access to Plan B has been contentious. In 2003, the FDA rejected an application to make Plan B available OTC, citing a lack of data on women under 16. In 2005, two FDA officials, Susan Wood and Frank Davidoff, resigned after the FDA announced that it was going to postpone the approval of OTC Plan B indefinitely. Finally, in 2006 and several rejections later, the FDA approved OTC Plan B but only for women 18 and older. In 2009, U.S. District Court Judge Edward Korman, ordered the FDA to allow OTC sales of Plan B for women 17 and older and urged that the FDA lift any age restrictions. According to Korman, the FDA’s decisions regarding Plan B were, “arbitrary and capricious because they were not the result of reasoned and good faith decision-making.” In addition, Judge Korman ordered the FDA to rule on the citizen’s petition with regards to OTC Plan B for women and girls under the age of 17.

Fast forward to today. A contempt hearing was scheduled in Tummino v. Hamburg for Tuesday, December 13 because the FDA had yet to comply with the court order. At that hearing, Judge Korman found the contempt motion moot because the FDA had denied the citizen’s petition the previous night. However, Judge Korman invited CRR to re-file and add the Department of Health and Human Services and Secretary Sebelius as defendants.

According to FDA Administrator Margaret A. Hamburg, “Based on the information submitted to the agency, [The Center for Drug Evaluation and Research] determined that [Plan B One-Step] was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.” However, Secretary Sebelius directed the FDA to deny OTC approval for Plan B for females under the age of 17. In light of such evidence, Judge Korman stated, “I think we ought to deal with whether the secretary is focusing on the adequacy of the studies.” Judge Korman also ordered the FDA’s lawyer, Assistant U.S. Attorney Scott Landau to turn over the evidence used to make the Plan B decisions. In response to an objection from Landau that the information was proprietary, Judge Korman told him to submit a sworn statement that HHS had not ignored evidence that, for instance, girls as young as 12 might properly use Plan B. Korman further staid that it “would be the height of arbitrariness” if it had.

Although agencies are allowed to consider policy and political priorities in their decision-making, the underlying record must support the agency’s stated justification. In this case, Secretary Sebelius said that the evidence did not do not “conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” Although the “arbitrary and capricious” standard typically favors letting agency decisions stand, the Secretary’s rationale may not hold up under judicial scrutiny given that the FDA’s review found that the evidence did support making Plan B available OTC to women and girls of all ages. In fact, this is believed to be the first time an FDA recommendation was overruled in this manner.

Stay tuned. Those of us concerned about reproductive justice and ensuring that agency decision making is evidence-based will be watching this case closely.

Related Links:
Revived Lawsuit Could Be Key to Overturning Plan B Decision [Jezebel]
Obama Administration Refuses to Relax Plan B Restrictions [The Washington Post]
Plan B’s Complicated History [Newsweek]

Posted in FDA, National Healthcare, Uncategorized ; Tagged: , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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