Tummino v. Hamburg

Morning-After Pill Availability

Tummino v. Hamburg: Morning-After Pill Availability. Photo Courtesy of Lori A.

The Tummino v. Hamburg case was finally decided April 5, 2013. In his Memorandum Opinion and Order, Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York reversed a prior decision by the Food and Drug Administration (FDA) and Health and Human Services (HHS) by ruling that the morning-after pill should be made available without a prescription or any age restrictions.

This court order serves as a major victory in the history of emergency contraception


Tummino v. Hamburg was originally filed (as Tummino v. Torti) on January 21, 2005, and accused the FDA that its failure to approve over-the-counter (OTC) use of Plan B (the morning-after pill) created many barriers for women to access this emergency contraceptive.

This federal suit was in response to a denied 2001 Citizen Petition, filed by the Center for Reproductive Rights on behalf of more than 70 medical and public health organizations, that urged the FDA to switch the morning-after pill availability from prescription-only to OTC status. The plaintiffs argued that the FDA’s denial of the Citizen Petition was "arbitrary and capricious because it was not the result of reasoned and good faith agency decision-making."

On March 23, 2009, Judge Edward R. Korman agreed with the plaintiff’s claim, ruling that the FDA’s lengthy delays and rejection of the evidence provided by its own scientists showed "a lack of good faith and reasoned agency decision-making." Korman also pointed out that the agency put politics before women's health in its decision to limit OTC morning-after pill availability to women over 18.

The court further concluded that the FDA "departed in significant ways from the agency's normal procedures," acted with "repeated and unreasonable delays," and that the agency’s reason for denying OTC access to 17-year-olds "lacks all credibility." Judge Korman ordered the FDA to allow the manufacturer of Plan B to market this emergency contraceptive, without a prescription, to those aged 17 and older to come up with an evidence-based answer to the question of OTC availability for younger girls.

The court also ordered the FDA to reconsider its decision on the Citizen Petition as well as to consider lifting all age restrictions on the morning-after pill availability.


Lead Plaintiff - Annie Tummino (of the National Women’s Liberation)
Named Plaintiffs - Erin T. Mahoney, Carol Giardina, Kelly Mangan, Stephanie Seguin, Lori Tinney, Jennifer Brown, Candace Churchill, and Francie Hunt (also from the National Women’s Liberation); Association of Reproductive Health Professionals; and National Latina Institute for Reproductive Health.


Margaret Hamburg, FDA Commissioner
Kathleen Sebelius, Health, and Human Services (HHS) Secretary

Plaintiff’s Claim:

In Tummino v. Hamburg, the plaintiffs challenged the FDA’s arbitrary decision to restrict morning-after pill availability. The court was asked to remove age requirements and point of sale restrictions on all levonorgestrel-based emergency contraceptives (both one and two-pill versions) to ensure that the morning-after pill receives true OTC status and is widely available to females of all ages.

Tummino v. Hamburg - Summary:

Following Judge Korman’s April 2009 ruling, the FDA approved Plan B One-Step behind-the-counter (no prescription status) for individuals age 17 and older. The agency then approved the same age requirements and point of sale restrictions on Plan B and Next Choice morning-after pill availability. Even though the FDA was court-ordered to reconsider the requests outlined in the Citizen Petition, the agency declared that the best way to do this was by waiting for the manufacturer of Plan B One-Step (Teva Pharmaceuticals) to file a new drug application that requested morning-after pill availability for all ages.

In February 2011, Teva Pharmaceuticals filed a supplemental new drug application with the FDA asking that the agency allows Plan B One-Step to be available OTC with no age restrictions (which included additional data confirming its safety for all age use). After reviewing all of the research and data, Margaret Hamburg (FDA Commissioner) announced that the FDA was willing to grant Teva’s application. Hamburg confirmed evidence of Plan B’s suitability and safety for all ages without the requirement of a prescription. The FDA’s approval for universal, OTC emergency contraceptive access was endorsed by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Adolescent Health and Medicine. Yet, in a move that had never been done before, Department of Health and Human Services Secretary Kathleen Sebelius (citing insufficient data) overruled the FDA’s decision and instructed the agency to deny Teva’s application.

A few days later, on December 12, 2011, the FDA denied the Citizen Petition. Thus, the case of Tummino v. Hamburg was filed on February 8, 2012, where the plaintiffs motioned to reopen this case, added Kathleen Sebelius as a defendant, and asked the court for a summary judgment that would allow OTC access for all levonorgestrel-based emergency contraceptives with no age or point of sale restrictions.

Due to the filing of Tummino v. Hamburg, the court first issued an Order to Show Cause to Defendants -- the court wanted to know "why the FDA should not be directed to 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 due."

Next Page: Tummino v.Hamburg Ruling and Significance

Tummino v. Hamburg - Ruling:

Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York issued his Memorandum Opinion and Order on April 5, 2013. In his 59 page order, Judge Korman laid out a detailed and thorough account of defining what emergency contraception is, how it works, and included a comprehensive review all the research on the morning-after pill as well as the FDA’s decision-making history with respect to this drug.

He went to great lengths to debunk the common misconception that the morning-after pill is akin to the abortion pill, specifically citing a Government Accountability Office report that collected scientific articles on the mechanism of levonorgestrel (the synthetic hormone in Plan B and Plan B One-Step).

Additionally, Judge Korman carefully considered compelling scientific evidence for the safety of the morning-after pill – concluding that Plan B "would be probably among the safest drugs approved for over-the-counter sale for the pediatric population," much safer than the cough syrups and diet drugs that teenagers are known to abuse yet are also available OTC. He further wrote,

"This case is not about the potential misuse of Plan B by 11-year-olds. ...Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions."
The Administrative Procedure Act (the statute that governs challenges to the actions of federal agencies) states that a court can overturn an agency’s action only if it finds it "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." In the Tummino v. Hamburg ruling, Judge Korman found that both the FDA’s decision to deny the Citizen Petition as well as Secretary Sebelius’ Plan B One-Step decision were arbitrary, capricious, and unreasonable. He reversed the FDA’s decision of denying the Citizen Petition and instructed the FDA to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available OTC with no age or point-of-sale restrictions. He did state that the FDA has the discretion to determine if new labeling is reasonably necessary and conceded that if the agency truly believes there is a significant difference between Plan B One-Step (the one pill product) and generic Plan B (two pill product), the FDA would be allowed to limit OTC approval only to Plan B One-Step.


Judge Korman did not hold back in his opinion, writing that in overruling the FDA’s decision-making, Secretary Sebelius’ actions were "politically motivated, scientifically unjustified, and contrary to agency precedent," adding that Secretary Sebelius "failed to offer a coherent justification" for rejecting the recommendation of her department’s top scientists. The judge also found fault with Secretary Sebelius' motives and wrote that she was a direct source of "political interference." He added that,

"The motivation for the Secretary’s action was obviously political... it was an election-year decision that 'many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.'"

Judge Korman further justified his decision due to the hurdles experienced by women under the prevailing FDA policy on emergency contraception. He referenced a 2012 research study revealing that many pharmacies did not have the morning-after pill available on the day a woman needed it, that pharmacists routinely provided women with misinformation about how to obtain the morning-after pill, and that few pharmacies are open 24 hours a day. Judge Korman wrote,

"All of these barriers, not to speak of the need for adolescents under 17 to find a doctor and obtain a prescription, are created or exacerbated by the FDA’s unusual treatment of emergency contraception [and] can have the cumulative effect of preventing some women from accessing the drug within the short time frame during which it will be effective, thereby exposing them to increased risk of unwanted pregnancy and making the product’s limited OTC status useless. Unfortunately, this risk is especially great for young women and low-income women, two groups that could significantly benefit from timely access to and use of the product."
In his conclusion of the Tummino v. Hamburg ruling, Judge Korman scolded the FDA for purposely delaying decisions about morning-after pill availability, describing these delays as "an administrative agency filibuster." Judge Korman pointed out that it has been over 12 years since the Citizen Petition was filed and 8 years since this lawsuit had originally began. He remarked that "the FDA has engaged in intolerable delays in processing the petition [and tried to] stall proceedings. ...The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction."


Tummino v. Hamburg - Significance

This ruling is a momentous victory in the fight for reproductive rights. Judge Korman’s decision attempts to put an end to the long and political history of morning-after pill availability in the United States. The importance of the decision in this case is on par with the court rulings of Griswold v. Connecticut (1965) and Eisenstadt v. Baird (1972) -- the two Supreme Court cases that were responsible for legalizing birth control in the US.


Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP) (E.D.N.Y. Apr. 4, 2013). Accessed 5/1/13.

Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y, Mar. 23, 2009). Accessed 5/1/13.

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