November 4, 2013

The Ultimate Guide to the Legal Battle Over OTC Access to Emergency Contraception

In the October issue of the journal Contraception, authors from Harvard Law School and Brown University’s medical school trace the legal and political battles over non-prescription access to emergency contraception.

The authors date the legal dispute back to Jan. 21, 2005, when a coalition of organizations in favor of emergency contraception filed a lawsuit accusing the FDA of ignoring the science and safety and applying different standards to Plan B, a type of EC under review at that time, than the FDA applied to other drugs.

Of course, concern about access and the FDA’s process actually goes back further. Organizations had filed a Citizen Petition four years earlier asking the FDA to approve over-the-counter access. The FDA’s failure to respond to that petition, and rejection of the drug company’s application for OTC status, are what ultimately led to the 2005 lawsuit.

The article in Contraception covers the legal battles and notes the various ways the U.S. government interfered in the FDA’s decision-making. You might recall that politically motivated delays under the Bush administration led Susan Wood, a former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, to resign in 2005.

“I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” she said at the time of her decision.

After President Obama took office, and amid hopes that sound policy would prevail over politics, HHS Secretary Kathleen Sebelius overruled the agency’s 2011 decision that Plan B could be made available without a prescription or age restrictions. Noting this and subsequent political interference, the authors comment:

The final resolution of this controversy offers an ideal vantage point to examine the vulnerability of the FDA to political influence. While the FDA has “consistently been named or identified as one of the most popular and well-respected agencies in government”, the ability of the FDA to resist political influence is more precarious than its apparent reputation might suggest. After all, the FDA is not an independent agency. Indeed, the FDA Commissioner serves at the pleasure of the President. What is more, the idealized notion that the science-driven decision-making process of the FDA is insulated from and resistant to the political discourse is incommensurate with precedent.

Yes, that’s lawyer speak, but what it translates to is this: The Plan B drama has shown us that the FDA cannot be relied upon to make purely evidence-based decisions. At any time, a presidential appointee (like Sebelius) might step in to overrule evidence-based decisions. And as we’ve seen with Plan B, the resulting legal battle and limited access to a needed drug can stretch on for years.

Without a doubt, as the authors note, “there can be little questioning the foot dragging and active role played by two successive presidential administrations in shaping the emergency contraception debate.”

Plus: For more on the history of the fight for OTC emergency contraception, view a timeline from the Center for Reproductive Rights, and the original Citizen’s Petition, and check out coverage at Our Bodies, Our Blog. Important posts for context include this item on  Sebelius overriding the FDA’s decision, Susan Wood’s response at the time, and more history of the battle for increased access to EC.


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