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GAO Finds Irregularities in Plan B Application

The struggle for over-the-counter access to emergency contraception (EC) has been very difficult. Time and time again the U.S. Food and Drug Administration (FDA) has delayed or denied the switch from prescription only to over-the-counter for EC. The GAO (Government Accountability Office), whose job it is to hold the FDA accountable for any fishy business, recently reviewed the case of the emergency contraceptive, Plan B.  The FDA denied over-the-counter (OTC) status to Plan B, keeping it available through prescription only.  However, the FDA’s decision-making process in this case was highly irregular.  The GAO reviewed this process and noticed four main abnormalities:
  

1) The directors normally responsible for signing off on the denial of OTC status refused to sign the not-approval letter for Plan B.  Plan B was not granted OTC status, making it the only prescription OTC case from 1994 to 2004 that was denied despite the overwhelming recommended approval of FDA’s own scientific advisory committees.

2) High-level management, usually un involved in similar OTC switch cases, was highly involved in the Plan B case.  The Plan B application was the only case from 1994 to 2004 signed by higher level officials who would normally not sign them.

3) The GAO received conflicting accounts of when Plan B was officially not approved for OTC status, possibly even before the scientific reviews were complete. The Director and Deputy Director off the Office of New Drugs, along with other officials, told the GAO that they were notified in December 2003 and January 2004 that the Plan B OTC application would not be approved.  However, the GAO reports that the Acting Director of the Center for Drug Evaluation and Research (CDER) did not have his rationale for Plan B’s OTC status denial fully developed until May 2004.

4) The Acting Director’s rationale for signing the not-approval letter was novel and very different from traditional FDA behavior.  He used the argument that data regarding older adolescents could not be used to apply to younger adolescents.  However, not only did medical professionals agree that the data could indeed be applied, but the very doubt was never brought up previously for similar cases.

This case is significant because it shows that the decision-making process for changing Plan B to OTC was unusual, to say the least.  It seems to indicate that, despite medical science, tradition, precedent, and an overwhelming positive response from committee members, government higher-ups refused to grant Plan B OTC status because of their own agenda.  Once again, this is an instance of the government trying to regulate women’s bodies and women’s choice!

Download the full GAO report here (PDF).

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