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08.13.13 - 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
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; Robert Jaffre; Aurora DeMarco; Angelica Jaffe; Catherine Lederer-Plaskett; Aliza Lederer-Plaskett; Jonathan Marks; Gabirelle Marks; Tracy Gaffin; and Anaya Kelly.
Center Attorney(s): Janet Crepps
Co-Counsel/Cooperating Attorneys: Andrea Costello, Partnership for Civil Justice Fund, and Kirsten Clanton, Southern Legal Counsel, Inc. (for the individual plaintiffs)
Summary: The Center has engaged in a more than 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 recommendations of its own scientific review staff. Moreover, no drug other than Plan B has been 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. 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 a supplemental new drug application (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 12, 2011, 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 over the counter (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.
On April 5, 2013, the court granted summary judgment to the Plaintiffs on the grounds that the FDA, acted arbitrarily and unreasonably in once again denying the Citizen’s Petition. The Court found that the agency’s action was a direct result of the Secretary’s unprecedented and politically motivated decision to overrule the FDA’s recommendation allowing Plan B One-Step to go over the counter without restrictions. The court ordered the FDA, within 30 days, to allow levonogesterel emergency contraception to go completely over the counter, but granted the FDA discretion to decide if over-the-counter access should be limited to one pill products.
Instead of complying with the court’s order, the FDA approved an application by Teva for Plan B One Step to be made available OTC for women 15 years and older. The Defendants then filed a notice of appeal with the Second Circuit Court of Appeals and a Motion for Stay with the District Court. During oral argument on May 7, the court publicly rebuked the Defendants’ arguments, likening the age restrictions and I.D. requirements for EC to voter suppression and citing the disproportionately negative impact of these arbitrary restrictions on young women, poor communities, and women of color. Accordingly, the court denied the Motion for Stay on May 10.
The Defendants filed a Motion for Stay with the Second Circuit, asking to be excused from compliance with the District Court’s order while their appeal was pending. At the beginning of June, the Second Circuit held that the Government had to make the two-pill products available immediately, but not one-pill products.
The Government then opted to make Plan B One-Step available, rather than the two-pill products, and so, on June 10, 2013, they submitted a letter to the district court asking if approval of an sNDA from Teva to make Plan B One-Step available OTC without any age or point of sale restrictions would satisfy the April 5, order. On June 12, 2013, the court approved the Government’s proposal, and on June 20, 2013, the FDA announced that it had approved Teva’s request to make Plan B One-Step available OTC. Teva is now distributing the product to pharmacies and grocery stores, including stores that do not have a pharmacy on-site. Because it has now complied with Judge Korman’s order, the Government dismissed its appeal to the Second Circuit on July 23, 2013.
While Plan B One-Step is now out on the shelves in some locations, the FDA unfortunately granted Teva three years of exclusivity, which means that until April of 2016, generic products will only be available for those 17 and older with proof of age, and to women under 17 or without ID by prescription. This decision came in spite of the district court’s plea to the FDA not to grant exclusivity, which would "only burden poor women" by keeping restrictions in place for less expensive products. In spite of this, our long-fought battle over access to emergency contraception has resulted in significantly increased access to a safe and effective means of preventing unwanted pregnancy.