Tummino v. Hamburg (NY)

03.23.09 -  This case challenges the arbitrary decision of the U.S. Food and Drug Administration (FDA) to restrict access to emergency contraception (EC).

Filing date: 01/21/2005; Re-opened 2/15/2012

State: New York

Plaintiff(s): Annie Tummino; Erin T. Mahoney; Carol Giardina;  Kelly Mangan; Stephanie Seguin; Lori Tinney; Jennifer Brown; Candace Churchill; and Francie Hunt; Association of Reproductive Health Professionals; and National Latina Institute for Reproductive Health.

Center Attorney(s): Suzanne Novak, Janet Crepps

Co-Counsel/Cooperating Attorneys: Andrea Costello, Florida Institutional Legal Services, and Kirsten Clanton, Southern Legal Counsel, Inc. (for the individual plaintiffs)

Summary: The Center has engaged in a decade long battle to make emergency contraception available without restrictions for all women. In 2001, the Center, along with the Reproductive Health Technologies Project and numerous women's health organizations, filed a Citizen Petition with the FDA, urging the agency to switch emergency contraception drugs from prescription-only to over-the-counter status. Shortly thereafter, the manufacturer of the EC product Plan B submitted its own application to the FDA seeking to make Plan B available over-the-counter. The FDA responded to our Citizen Petition and to the Plan B application with years of unexplained delay. After four years of waiting, the Center filed suit in federal court against the FDA, alleging that the agency's failure to approve Plan B for over-the-counter use impermissibly denied women access to EC.

In July of 2006, the FDA finally acted on the Plan B application and Citizen Petition, announcing that it would approve the distribution of emergency contraception without a prescription, but only behind the counter at pharmacies and only for women 18 or older who could produce government-issued identification as proof of age. In refusing to allow women under 18 to obtain Plan B without a prescription, the FDA went against the unanimous recommendations of its own scientific review staff. Moreover, no drug other than Plan B is subject to a two-tiered prescription/over-the-counter regime based on age. And no other over-the-counter drug requires production of identification for purchase. The testimony of FDA employees and officials clearly show that the FDA's decisions regarding emergency contraception were made on the basis of politics, rather than on considerations of the drug's safety and efficacy. This influence appears to have come from as far up as the White House.

On March 23, 2009, the court ruled that the FDA had put politics before women's health when it decided to limit over-the-counter access to Plan B to women over 18. It found that the FDA "acted in bad faith and in response to political pressure," "departed in significant ways from the agency's normal procedures," and engaged in "repeated and unreasonable delays." In addition, the court found that the FDA's justification for denying over-the-counter access to 17 year olds "lacks all credibility," and was based on "fanciful and wholly unsubstantiated 'enforcement' concerns."

The court ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. The FDA complied with this portion of the ruling on April 22, 2009, when it announced that it would clear the way for Plan B's manufacturers to make the "morning-after pill" available without a prescription to 17-year-olds. Currently, Plan B, Plan B One Step and Next Choice, a generic version of the drug, are all available without a prescription for women 17 and older. The court also ordered the agency to reconsider its decision on the Citizen Petition and the age and other point-of-sale restrictions.

Following the court's ruling, the agency acknowledged to the Center that the court had ordered it to reconsider the Citizen Petition, but subsequently took the position that it would not do so and that the best way for it to comply with the order was to wait for a new application from a drug manufacturer. In February 2011, Teva, the manufacturer of Plan B One-Step, a one pill version of emergency contraception, filed an SNDA with the FDA, requesting over the counter access without age restrictions. On December 7, 2011, the Commissioner of the FDA announced that the FDA was prepared to approve the SNDA, but, in an unprecedented move, the Secretary of Health and Human Services directed the FDA to deny Teva's SNDA. Secretary Sebelius said that after reviewing the data submitted with Teva's SNDA, she was unconvinced that the prescription dispensing requirements could be eliminated for all ages. On December 12th, the FDA then denied the Citizen Petition for reasons similar to its first denial, which the court had previously concluded were arbitrary and capricious, politically tainted, and a departure from agency norms.

On February 8, 2012, Plaintiffs filed a motion to reopen the case, add Secretary Sebelius as a defendant, and to supplement the complaint. Plaintiffs also filed a motion for a preliminary injunction and summary judgment seeking immediate relief that would allow OTC access for all levonogestrel-based EC (both one and two pill versions) with no age or point of sale restrictions. Following those filings, the court issued an order to show cause to the FDA, asking the FDA to explain why it should not make Plan B available to those persons whom the studies submitted to the FDA demonstrate are capable of understanding when the use of Plan B is appropriate and the instructions for its use.