For years, people have been passionately fighting both for and against morning-after pill legislation. As with other reproduction and sexual health issues (i.e., the use of contraception: Griswold v. Connecticut; the right to have an abortion: Roe v. Wade), the fate of morning-after pill availability was finally decided in the court room. On April 5, 2013, Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York rendered his decision in the Tummino v. Hamburg court case. In his historic verdict, Judge Korman reversed a previous Food and Drug Administration (FDA) and Health and Human Services (HHS) decision by ordering that the morning-after pill should be made available for people of any age without a prescription.
As with previous morning-after pill legislation, Judge Korman's ruling was met with debate and controversy. The final status of the Tummino v. Hamburg court case was played out on June 20, 2013 when the FDA finally made its official announcement that Plan B One-Step will now be available as a nonprescription (OTC) product for women of all ages. That being said, a lot happened in the two and a half months between Judge Korman's original ruling and the FDA's announcement.
Morning-After Pill Legislation Summary:
- As per Judge Korman’s April 5, 2013 ruling, the FDA had 30 days to comply with his court order.
- May 1, 2013: Just days before the FDA would have to comply to Judge Korman’s ruling, the Department of Justice filed an appeal. US Attorney Loretta Lynch wrote a letter to Judge Korman arguing that a district court does not have the jurisdiction to review the FDA’s actions. In a court filing, the DOJ also asked the judge for to suspend his order (so the FDA would not be obliged to fulfill Judge Korman’s ruling).
- May 7, 2013: Judge Korman heard arguments regarding the DOJ’s Motion to Stay his Order. The Justice Department requested this hearing to ask the judge to suspend his April 5 ruling while they appeal his decision. During this hearing, the judge characterized the government’s position as being unjustifiable... calling the government’s conduct a "charade" as well as condemning the "political influence" that is responsible for a "total and complete corruption of the administrative process."
- May 10, 2013: Judge Korman denied the DOJ’s Motion to Stay his Order. In his ruling, the judge characterized the defendants’ appeal as "frivolous and is taken for the purpose of delay." Criticizing the government for its inexcusable delays and attempts to stall decision-making with respect to morning-after pill accessibility, the Judge further warned that,
"If a stay is granted, it will allow the bad-faith, politically motivated decision of Secretary Sebelius, who lacks any medical or scientific expertise, to prevail – thus justifiably undermining the public’s confidence in the drug approval process."
Finally, the judge did grant a temporary suspension of his order to give the DOJ time to appeal to the 2nd U.S. Circuit Court of Appeals in Manhattan. The stay was permitted under the condition that the DOJ new motion for a stay be filed with the Court of Appeals by 12:00 PM on May 13, 2013.
- May 13, 2013: The Justice Department filed its appeal. In response, the 2nd U.S. Circuit Court of Appeals in Manhattan had agreed to temporarily prevent Judge Korman’s April 5th ruling from taking effect until May 28, 2013, and stated it would keep the order from being implemented until it hears from both sides.
- June 5, 2013: The 2nd U.S. Circuit Court of Appeals denied and granted the DOJ’s "motion to stay." The court ordered that the FDA must immediately comply with Judge Korman’s order that all forms of two-pill levonorgestrel-based emergency contraception be made available without a prescription, on store shelves, with no age restrictions. The court also granted the DOJ’s request to stay (restrict) Judge Korman’s order with respect to one-pill levonorgestrel-based emergency contraception pending the outcome of the DOJ’s appeal. The Appeals Court also ruled that the DOJ’s appeal will be heard on an expedited basis.
The Legal Maneuvering Takes Its Final Shift:
On June 10, 2013, in a letter to Judge Korman, the Justice Department wrote that it plans to drop the government’s appeal, and that the FDA and the Department of Health and Human Services will comply with his court order and will certify the morning-after pill (only one-pill versions) for nonprescription use. The DOJ also indicated that it would not allow for OTC status of the two-pill versions.
- It seems the rationale behind this decision was to prevent the two-pill generic levonorgestrel-based versions from having no age requirements or restrictions. As it stood, the June 5, 2013 order from the 2nd U.S. Circuit Court of Appeals instructed the FDA to allow all forms of the two-pill emergency contraception to be available OTC pending the decision of the DOJ’s appeal. Not wanting to risk losing their appeal, government officials decided that it was better to drop their appeal and comply with Judge Korman’s original April 5 ruling -- doing this would grant one-pill versions OTC status but prevented the two-pill versions from hitting store shelves.
- Though Judge Korman had criticized what he called "nonsensical" government rules that he said unfairly favored the one-pill version over the cheaper, generic two-pill version, his April 5 order did stipulate that if the FDA really thought that there is a noteworthy difference between one-pill product and two-pill products, the agency would be permitted to limit OTC status to just the one-pill options (though he recommended that the agency adopt the OTC status for both products).
- The FDA chose not to remove restrictions for two-pill emergency contraceptives citing less available safety data on the use of the product by younger adolescents and concern that younger girls may not understand how to take two separate doses.
In this letter, the DOJ also outlined it’s understanding of Judge Korman’s decision, and the procedural steps that the FDA plans to take to be in compliance of the court order. The letter further stated that, "Once the Court confirms that the government's understanding is correct, the government intends to file with the Circuit Court notice that it is voluntarily withdrawing its appeal in this matter."
According to a June 10, 2013 FDA statement, the agency had asked Teva Pharmaceuticals, manufacturer of Plan B One-Step, to file an application asking for no age or sales restrictions, and once that application is received, the FDA planned to promptly approve it. It was also expected that once this takes place, manufacturers of one-pill generic versions to request the same status, with the expectation that the generic alternatives would eventually be granted OTC status as well.
- June 12, 2013: Judge Edward Korman issued a memorandum indicating that although the government’s understanding of his court order was not entirely correct, the DOJ’s plan to approve just one-pill versions of the morning-after pill "is sufficient to comply" with his order (even though he agreed that the FDA has "failed to establish that any significant difference between the one-pill and two-pill products exists that would justify the continued restriction of the two-pill version"). The judge also warned that any undue delay with approving Teva’s application will not be tolerated.
Judge Korman also expressed his concern over the possibility that the FDA may grant Teva marketing exclusivity on Plan B One-Step, thus prohibiting generic, one-pill versions from being sold OTC for three years serving only to "burden poor women." In his opinion, he indicated that it did not appear that the standards for exclusivity have been met. Finally, the judge reminded the government that it was not Teva that mounted (or incurred financial costs from) this 12 year legal battle over OTC availability of the morning-after pill. And concluded with,
"It is only because of the extraordinary efforts by the plaintiffs in pursuing their Citizen Petition that Teva is able to seek approval of an [application] that will permit it to market its product [OTC]. Such approval, if given, will be nothing more than a reward to Teva for playing along with the defendants’ efforts to maintain their legally and scientifically unjustified restrictions on the marketing of levonorgestrel-based emergency contraceptives. It is the plaintiffs, rather than Teva, who are responsible for the outcome of this case, and it is they, and the women who benefitted from their efforts, who deserve to be rewarded."
The FDA announced on June 20, 2013, that the agency has approved Teva's supplemental application and that Plan B One-Step will now be available OTC with no age restrictions. Despite Judge Korman's opinion, the FDA also granted Teva three years of exclusivity to sell Plan B One-Step OTC; when Teva's patent expires on April 30, 2016, manufacturers can submit supplemental FDA applications for one pill emergency contraceptive generic alternatives to be sold OTC.
February 25, 2014:
Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, sent a letter to the manufacturers of Next Choice One Dose and My Way (the one-pill generic versions of Plan B One-Step). The letter explained that,
“In the FDA’s view, this characterization of the exclusivity is too broad and Teva’s proposal for conditions on [generic product] labeling and marketing is too restrictive.”
The letter went on to state that although Plan B One-Step may now be sold OTC because it no longer has prescription-only status,
“This does not mean that Teva is entitled to broad exclusivity covering Plan B One-Step’s status as a nonprescription product for women of all ages.”
This letter concluded by informing these generic manufacturers that their products are now eligible for FDA-approval to be sold directly from retail shelves with no age restrictions as long as they include on their labels that they are intended for use in "women 17 years of age or older." (Inclusion of this labeling requirement ensures that the generic versions do not specifically indicate use in populations for which Teva has exclusivity).
So... under existing morning-after pill legislation, emergency contraception availability is as follows:
- Plan B One-Step -- available over-the-counter (without a prescription) to those of any age.
- Next Choice One Dose, My Way, and Take Action (Plan B One-Step generic products) -- can be sold OTC, without a prescription or age requirements.
- Plan B generic Next Choice (two pill emergency contraception) -- available behind the pharmacy counter, without a prescription, for those aged 17 and older. A prescription is needed for those under 17.
For More Information on Morning-After Pill Availability and Use:
- How to Correctly Use the Morning-After Pill
- Where and How to Buy Plan B One-Step, My Way, Take Action, and Next Choice One Dose
Department of Health and Human Services. "Letter to NDA/ANDA Applicant Regarding Plan B One-Step Exclusivity." (February 25, 2014). Accessed 3/3/14.
Tummino v. Hamburg No. 12-CV-763 (ERK)(VVP) (E.D.N.Y. June 12 2013). Accessed 2/27/14.
Tummino v. Hamburg (No. 12-CV-763) Case: 13-1690 (U.S. Court of Appeals for the Second Circuit June 5 2013). Accessed 6/6/13.
Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP) (E.D.N.Y. May 10 2013). Accessed 2/27/14.
Tummino v. Hamburg, No. 12-CV-763 (ERK)(VVP) (E.D.N.Y. Apr. 4, 2013). Accessed 2/27/14.