By Kurt R. Karst –
In a surprising turn of events, the Department of Justice (“DOJ”) sent a letter to Judge Edward R. Korman of the U.S. District Court for the Eastern District of New York indicating that FDA and HHS have complied with his April 10, 2013 Judgment by granting a 2001 Citizen Petition (Docket No. FDA-2001-P-0123) and will make PLAN B One-Step (levonorgestrel) Tablets, 1.5 mg (“PBOS”) available Over-the-Counter (“OTC”) without age or point-of-sale restrictions upon the aproval of a supplemental New Drug Application (“SNDA”) submitted by the application sponsor, Teva Branded Pharmaceutical Products R&D, Inc. (“Teva”). The letter also states that once Judge Korman confirms that the government’s course of action fully complies with his April 10th Judgment, the Obama Administration intends to file with the U.S. Court of Appeals for the Second Circuit notice that it is voluntarily withdrawing its appeal of the District Court’s April 5th Memorandum and Order and April 10th Judgment (see our previous post here).
The government failed to win a stay pending appeal from Judge Korman in May (see here), who had previously ordered FDA to make, within 30 days, levonorgestrel-based emergency contraceptives (e.g., PLAN B and PBOS) available OTC and without point-of-sale or age restrictions. Last week, the Second Circuit granted in part and denied in part the government’s Motion for a Stay Pending Appeal, ruling that “[i]nsofar as the district court order requires Appellants to immediately provide over-the-counter access to the one-pill variants of emergency contraceptives [(i.e., PBOS)], a stay, pending appeal, is granted. Insofar as the order mandates immediate over-the-counter access to the two-pill variants of emergency contraceptives [(i.e., PLAN B)], a stay is denied because the Appellants have failed to meet the requisite standard.”
According to the DOJ letter and petition response, FDA has invited Teva to promptly submit a SNDA to the PBOS NDA with proposed labeling that would permit the drug product to be sold OTC and without age or point-of-sale restrictions, which FDA will approve “without delay.” The SNDA could apparently rely on a supplement Teva submitted to FDA on February 7, 2011 seeking to remove the prescription-only status of the drug product for women younger than age 17 and to make PBOS OTC for all women of childbearing potential. The letter and petition response also explain that “FDA will not at this time take steps to change the approval status of the two-pill Plan B or its generic equivalents” According to FDA, this scheme is consistent with Judge Korman’s Judgment:
[T]this Court’s April 10, 2013, judgment expressly authorized FDA to comply by making PBOS and not Plan B available, if FDA believes that there is a significant difference between Plan B and PBOS. Specifically, while the Court’s judgment directed the defendants to “make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days,” it also provided that “FDA may determine whether any new labeling is reasonably necessary” and that “if the FDA actually believes that there is any significant difference between the one- and two- pill products, it may limit its over-the-counter approval to the one-pill product.” FDA continues to believe, for the reasons that the government has previously explained in its briefs to this Court, that there are significant differences between Plan B and PBOS under FDA’s regulations and the [FDC Act]. . . . 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 for younger adolescents. [(Internal citation omitted)]
The government’s decision, if accepted by Judge Korman, would likely bring to a close a battle that has raged on for 12 years. But might FDA’s decision also create a new controversy?
As we previously discussed, FDA apparently granted a period of 3-year exclusivity with respect to the PBOS SNDA approved on April 30th making the drug available OTC to women of childbearing potential aged 15 years and over who are in need of emergency contraception. The existence of such exclusivity could affect the approval status of generic versions of PBOS approved under ANDAs and seems to raise the thorny issue of simultaneous prescription and OTC marketing of the same drug. An FDA decision to approve a new SNDA with another period of 3-year exclusivity to remove the prescription-only status of PBOS for women younger than age 17 and to make the drug product available OTC for all women of childbearing potential might compound the potential problem. Both the DOJ letter and FDA petition response recognize this, but don’t get into a lot of detail:
After FDA receives and approves Teva’s supplement, we expect the sponsors of the generic versions of PBOS to submit appropriate amendments to their abbreviated new drug applications. If FDA grants Teva marketing exclusivity, the scope of that exclusivity may affect the labeling that could be approved for generic equivalents of PBOS.
So it seems that FDA may have teed up yet a new issue for debate – this time in the Hatch-Waxman realm. The issue could be quickly resolved with a waiver of exclusivity by Teva, but that may not happen. In any case, the issue may take a little while to work its way through the system.