EC Options for Obese Women
Analysis of data from the two randomized trials of the ulipristal acetate (UPA) and levonorgestrel (LNg) regimens found that when compared with women who were not obese, women taking LNg had a significantly higher risk of pregnancy whereas women taking UPA did not. LNG showed a rapid decrease of efficacy with increasing body mass index (BMI), reaching the point where it appeared no different from pregnancy rates expected among women not using EC at a BMI of 26 compared with a BMI of 35 for UPA.1 When clinically appropriate, the copper IUD is probably the best EC option for obese women, with a failure rate of 1 per 1,000.2
One- And Two-Pill EC Options
In August 2013, Plan B One-Step became available without prescription to males and females with no age restriction. In most pharmacies it is located on the shelf in the family planning aisle; some pharmacies may choose to keep it in a locked cabinet.One-pill generics (My Way and Next Choice One Dose) will soon be available on the shelf for consumers aged 17 and older, but this change has not taken effect yet; women aged 16 and younger still need a prescription. Two-pill generics (Levonorgestrel Tablets) are still available only behind the counter without prescription if you are 17 or older; younger women need a prescription. Price may be a barrier (see http://ec.princeton.edu/ASECPricingReport.pdf).
The Full History of Plan B Going OTC
An FDA advisory committee voted 23-4 in December 2003 that Plan B be switched from Rx to OTC, but the FDA rejected an OTC switch in May 2004 in an unprecedented repudiation of such an overwhelmingly positive advisory committee recommendation. The independent Government Accountability Office concluded that the decision process was highly unusual and that the decision was made with atypical involvement from top agency officials and may well have been made months before it was formally announced.3 Barr Laboratories submitted an amended application in July 2004 to make Plan B an Rx drug for females <16 and OTC otherwise. The FDA had until January 21, 2005 to respond. On July 15, 2005, HHS Secretary Leavitt promised that FDA would act on Barr’s application by September 1, 2005 to ensure a vote on Senate confirmation of Lester Crawford as FDA Commissioner. On August 26, 2005, FDA announced that Plan B was safe for OTC use by women ?17. But the FDA announced an indefinite delay in reaching a decision, citing three concerns: (1) can Plan B be both Rx and OTC depending on age?; (2) can Rx and OTC versions of the same drug be marketed in the same package?; and (3) can an age restriction be enforced? The FDA also announced a 60-day public comment period on first two concerns. The FDA failed to articulate clear criteria or explicit timetable for a final decision.
This indefinite delay was heavily criticized.4 Finally, on August 24, 2006, the FDA approved the nonprescription sale of Plan B for women and men aged 18 and older. This age cutoff was not chosen based on any medical evidence that young women could not use emergency contraceptive pills safely or correctly, but rather, according to the FDA’s Steven Galson, because it was easy for pharmacists to remember and enforce, since it is the same age limit placed on tobacco and nicotine-replacement products.
In January 2005, the Center for Reproductive Rights 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 March 2009, The U.S. District Court for the Eastern District of New York in a blistering decision ordered the agency to reconsider its decision. It also ordered the FDA to act within 30 days to extend over-the-counter access to 17-year-olds. Judge Edward R. Korman was exceedingly blunt, stating that FDA had “acted in bad faith and in response to political pressure” and “repeatedly and unreasonably delayed issuing a decision on Plan B” and that the FDA’s denial of nonprescription access to 17-year-olds “lacks all credibility” and was based on “fanciful and wholly unsubstantiated ‘enforcement’ concerns.”5 On April 22, 2009 the U.S. Food and Drug Administration announced that it would clear the way for Plan B’s manufacturer to make it available without a prescription to 17-year-olds. And on July 13, 2009, the FDA approved Plan B One Step as a nonprescription drug for women and men aged 17 and over. On February 7, 2011, Teva submitted actual-use study data and label-comprehension study data on females <18 to the FDA. On December 7, 2011, the FDA was set to approve OTC status for Plan B with no age restriction based on the studies submitted by Teva.However, this action was overruled by the Secretary of Health and Human Services Kathleen Sebelius. Teva then filed an amended application to make Plan B One-Step available without prescription to consumers aged 15 and over and to allow it to be available in the family planning section of a pharmacy rather than behind the pharmacy counter; proof of age would still be required at checkout. On April 30, 2013, the FDA approved this amended application. In the meanwhile, on April 4, 2013, U.S. District Judge Edward R. Korman ordered the FDA to allow over-the-counter sales of LNg ECPs with no age restriction. In a scathing rebuke to the Obama administration, he stated that “the secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent.”6 On May 1, 2013, the Department of Justice announcedthatwouldappealhisruling.The Department of Justice appealed and asked for a stay of the orderuntil the case washeard. On June 5, 2013, 2nd Circuit Court of Appealsorderedthat the FDA must complywith Judge Korman’sruling to make 2-pill formulation of LNG EC availablewithout restriction butgranted astayregarding 1-pill formulation.7 On June 10, in a letter to Judge Korman, the Department of Justicesaiditwouldcomplywithhisdemandthat Plan B One-Step be made available OTC with no age restriction.8 Twodayslater, Judge Kormanapprovedthe Obama Administration’s plan to make Plan B One-Step (and only Plan B One-Step) available OTC with no age restriction.9
1 Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84:363-7.
2 Cleland K, Zhu H, Goldstruck N, Cheng L, Trussell J. The efficacy of IUDs for emergency contraception: a systematic review of 35 years of experience.Hum Reprod.2012;27:1994-2000.
3 Decision process to deny initial application for over-the-counter marketing of the emergency contraceptive drug Plan B was unusual. Washington DC: Government Accountability Office, 2004. Available at http://purl.access.gpo.gov/GPO/LPS66189. Accessed 7 June 2010.
4 Wood AJJ, Drazen JM, Greene MF. A sad day for science at the FDA.N Engl J Med. 2005;353:1197-8.
5 Decision available at: http://www.nylj.com/nylawyer/adgifs/decisions/032409korman.pdf.
6 Decision available at https://www.nyed.uscourts.gov/sites/default/files/opinions/Tummino%20SJ%20memo.pdf
7 Decision available at https://www.nyed.uscourts.gov/sites/default/files/opinions/Tummino%20SJ%20memo.pdf
8 Letter available at http://www.scribd.com/doc/147020358/Letter-to-Korman-Re-Compliance-After-Denial-of-Stay-Rev-Final-Copy
9 Memorandumavailableat http://www.justiceonline.org/docs/court-memorandum-tummino.pdf
James Trussell, PhD, Professor of Economic and Public Affairs, Princeton University.