BROOKLYN, N.Y. - (Mealey's) The federal government on June 10 told a federal judge that it will make the one-pill Plan B One-Step emergency contraceptive available without age or point-of-sale restrictions and intends to voluntarily withdraw its appeal of the judge's order requiring the lifting of all restrictions (Annie Tummino, et al. v. Margaret Hamburg, et al., No. 12-763, E.D. N.Y., Annie Tummino, et al. v. Margaret Hamburg, et al., No. 13-1690, 2nd Cir).
(Letter available. Document #28-130620-003X. Citizen petition letter available. Document #28-130620-004X.)
In a letter to U.S. Judge Edward R. Korman of the Eastern District of New York, U.S. Attorney Loretta E. Lynch of the Eastern District said the U.S. Department of Health and Human Services and the Food and Drug Administration have complied with Judge Korman's April 10 judgment by granting a 2001 citizen petition by the Center for Reproductive Rights to make Plan B One-Step available over the counter and without age or point-of-sale restrictions.
The FDA had in April approved Plan B One-Step to be sold over-the-counter to women 15 years and older with proof of age and if sold in a store that has an on-site pharmacy.
"It is the government's understanding that this course of action fully complies with the Court's judgment in this action," Lynch said. "Once the Court confirms that the government's understanding is correct, the government will file with the Circuit Court [Second Circuit U.S. Court of Appeals] notice that it is voluntarily withdrawing its appeal in this matter."
Labeling Change Invited
Lynch said the FDA on June 10 invited the manufacturer of Plan B One-Step, Teva Branded Pharmaceutical Products R&D Inc., to promptly submit a supplemental new drug application (SNDA) with proposed labeling that will permit Plan B One-Step to be sold without a prescription and without age or point-of-sale restrictions. "Upon receipt of the SNDA, FDA will approve it without delay," Lynch said.
The U.S. attorney said that after the FDA receives and approves Teva's SNDA, it expects that sponsors of generic versions of Plan B One-Step will submit amendments to their abbreviated new drug applications.
Lynch also told Judge Korman that the FDA on June 10 issued a response to the 2001 citizen petition by outlining the steps the agency is seeking with respect to Plan B One-Step.
No Change For 2-Pill Version
However, Lynch said, "FDA will not at this time take steps to change the approval status of the two-pill Plan B or its generic equivalents." She said that although Judge Korman ordered the FDA to make levonorgestrel-based emergency contraceptives available without prescription or age or point-of-sale restrictions within 30 days of the order, the order also said that the FDA may determine whether any new labeling is reasonably necessary and that if the agency believes there is a significant difference between Plan B and Plan B One-Step, it may limit its over-the-counter approval of the one-pill product.
"FDA continues to believe, for the reasons that the government has previously explained in its briefs to the Court, that there are significant differences between Plan B and PBOS [Plan B One-Step] under FDA's regulations and the Food, Drug and Cosmetic Act," Lynch wrote.
The government's attorney also said Teva's Plan B One-Step application contained actual use data addressing the ability of adolescents to understand and follow directions for the drug. "[T]here are fewer data available regarding the actual use of Plan B as a non-prescription product by younger adolescents," she wrote.
"FDA therefore believes it is appropriate and consistent with this Court's order to comply by making only PBOS (and not the two-pill product) available OTC [over-the-counter] to younger adolescents."
Plan B Stance 'Unjustified'
Attached to Lynch's letter is the FDA's response to the 2001 citizen petition.
In a June 10 press release, Nancy Northrup, president and CEO of the Center for Reproductive Rights, praised the lifting of restrictions for Plan B One-Step but said the "the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brand of emergency contraception."
"We are pleased that women should soon be able to buy Plan B One-Step without the arbitrary restrictions that kept it locked behind the pharmacy counter when they needed it most urgently," Northrup said. "But we will continue to fight for fair treatment for women who want and need more affordable options."
Citizen Petition, Litigation
When the center and 60 other family planning and women's health organizations filed the citizen petition, only two-pill versions of levonorgestrel-based emergency contraception were available. When the FDA failed to act on the citizen petition, some of the petitioners sued.
Judge Korman found that the FDA's decisions were being politically influenced by the Bush administration and remanded the issue after the Obama administration came in. When the FDA instead made Plan B prescription for women under 17 and nonprescription but behind the counter for women over 17, the defendants reopened their case.
In April, Judge Korman found that the FDA acted in bad faith, noting that the FDA staff recommended lifting all restrictions for the emergency contraceptives but were overruled by Health and Human Services Secretary Kathleen Sebelius, who has no scientific background. Judge Korman ordered the FDA to immediately make all levonorgestrel-based emergency contraceptives available without restriction.
The FDA responded by approving Teva's application for Plan B One-Step and appealing Judge Korman's order. The judge stayed his order only as a courtesy to the Second Circuit, accusing the government of engaging in delay tactics.
Cost, Age Requirements Questioned
Judge Korman criticized the FDA's approval of Plan B One-Step as a "sweetheart" deal with Teva, which received limited exclusivity to market the drug and charged more than generic levonorgestrel-based contraceptives cost. The judge and the plaintiffs were also critical of the age restriction, saying many 15-year-olds and minority females may not have government-issued identification such as a driver's license.
Last week, the Second Circuit granted a stay as to Plan B One-Step but not as to Plan B.
The government is represented by Senior Counsel F. Franklin Amanat and Lynch of the U.S. Attorney's Office in Brooklyn, Stuart F. Delery, Beth S. Brinkmann, Mark B. Stern and Adam C. Jed of the U.S. Justice Department in Washington, D.C., and David J. Horowitz, Elizabeth H. Dickinson, Annamarie Kempic and Scott A. Kaplan of the U.S. Department of Health and Human Services in Washington.
The plaintiffs are represented by Kirsten Clanton of Southern Legal Counsel Inc. in Gainesville, Fla., Andrea Hope Costello and Mara Verheyden-Hilliard of the Partnership for Civil Justice Fund in Washington and Janet L. Crepps of the Center for Reproductive Rights in Simpsonville, S.C.
Intervenor Teva Women's Health is represented by Michael D. Shumsky of Kirkland & Ellis in Washington.
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