Wolters Kluwer Lecture Series: Plan B Controversy

On February 25, Danielle Capilla and Nicole Stone spoke to students and attorneys on the new issues facing Over-the-Counter (“OTC”) access to Emergency Contraception (“EC”) in wake of the Patient Protection and Affordable Care Act (“PPACA”) and its Preventative Services Mandate. The Mandate requires health insurance policies to cover preventative services such as FDA-approved ECs. [1]

The lecture began with a brief overview of the history and functions of ECs, which led into issues with OTC access to such medications. Although contraception and abortion naturally spark strong emotional debates, Capilla noted that ECs are especially peculiar because they are often mistakenly co-mingled with abortifacients, despite critical differences in how the drugs operate. [2] ECs are intended for use after sexual intercourse and prevent pregnancy in one of two ways: (1) preventing fertilization by “keeping a woman’s ovary from releasing an egg for longer than usual” or (2) in the event of fertilization, preventing the fertilized egg from attaching to the womb. [3] ECs, however, are ineffective if taken after the egg is implanted. Abortifacients, such as mifepristone or “the abortion pill,” abort fertilized eggs that have already attached to the womb. [4]

This illustrates how labeling ECs as abortifacients is a misnomer. Because ECs prevent the egg from ever being fertilized, or attaching to the womb, there is nothing to abort. This mistaken co-mingling is causing problems in the ongoing litigation from religious-based businesses challenging the Preventative Care Mandate that requires them to cover such medications. [5]

A larger aspect of the debate over ECs concerns OTC availability. ECs were first approved by the Food and Drug Administration (“FDA”) in 1998 for prescription use only. In 2001, the Center for Reproductive Rights filed a Citizen Petition with the FDA requesting that ECs be made available OTC. The FDA did not respond until 2006, when it denied the petition. Before the first petition was answered, a drug manufacturer filed an application with the FDA in 2003 to grant OTC access to ECs. The FDA denied the application in 2006 stating the data contained inadequate sampling. [6]

After denying the application and petition, the FDA recommended that Plan B’s manufacturer amend its application to limit OTC access to women sixteen and older. When the FDA failed to make a timely decision, the Center for Reproductive Rights filed suit against the FDA in 2005. The litigation ended in 2013 when a district court Judge ordered the FDA to approve OTC access to ECs for women of all ages. [7]

Now that ECs are available OTC and must be covered by insurance policies, a residual issue is whether religious-based employers will be required to cover the medications under their employee benefit plans. Another unanswered question is whether all pharmacies will be required to carry ECs, and whether their employees must distribute them upon request, when doing so would violate their religious or moral beliefs.

 

References:

[1] The Patient Protection and Affordable Care Act, Pub. L. 111-148 (2010).

[2] Strategic Perspectives: Controversial “Morning After Pill” Subject of Emotional Debate Regarding OTC Access,Wolters Kluwer Health Law Daily (December 2013).

[3] Id.

[4] Id.

[5] Id.

[6] Id.

[7] Id.