Last week a federal judge ordered the Food and Drug Administration to make the Plan B emergency contraceptive pill available to young teens and girls without a prescription. The ruling overturns a controversial 2011 Obama administration decision restricting access to the drug for girls under age 17. The Plan B pill was first approved in 1999 as an emergency contraceptive and made available with a prescription. In 2006 the FDA approved access to Plan B without a prescription to women 18 and older. Women under 18 still required a prescription.
In Tummino v. Torti, a case decided in the Federal Eastern District of New York on April 9, 2013, the court ordered the FDA to make the contraceptive accessible to all women without point-of-sale or age restrictions within thirty days. The Tummino case involved individuals, parents and women’s health organizations who were seeking to expand the availability of Plan B and all emergency contraceptives by requiring the FDA to allow over-the-counter access to Plan B for women of all ages. The lawsuit was originally filed in January 2005, but the case has been significantly delayed due to political pressure placed on the FDA. The court found that the FDA’s decision to impose age restrictions was arbitrary and capricious because it was not the result of “reasoned and good faith agency decision-making.” The court acknowledged both the controversial nature of the case and the underlying political pressure, noting:
This case has proven to be particularly controversial because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs. Nevertheless, the issue in this case involves the interpretation of a general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale. The standards are the same for aspirin and for contraceptives. While the FDA properly recognizes that cognitive and behavioral differences undermine “the ability of adolescents to make reasoned decisions about engaging in sexual intercourse,” the standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug “safely and effectively.”
Essentially, the court found that the FDA did not have the authority to mandate point-of-sale restrictions on drugs approved for nonprescription sale that it found to be safe and effective for all women of childbearing age.