Generic EC — One step closer to OTC status
Executive Summary
The Food and Drug Administration is looking to generic versions of the levonorgestrel-based emergency contraception (EC) pill Plan B One-Step to submit applications for new labeling after the agency ruled the generic version can be sold on store shelves without restriction.
• Labels for generic drug versions must indicate the product is intended for use only by women ages 17 and older, but women will not need to show proof of age to purchase it.
• Generic EC products will be able to drop the age limit in their labeling entirely when Plan B One-Step loses its market exclusivity labeling for ages 16 and under on April 30, 2016. Age restrictions for Plan B One-Step were lifted in June 2013 when the United States dropped its appeal against an earlier court order to remove such restrictions.
The Food and Drug Administration (FDA) is looking to generic versions of the levonorgestrel-based emergency contraception (EC) pill Plan B One-Step (Teva Pharmaceuticals, North Wales, PA) to submit applications for new labeling after the agency ruled the generic version can be sold on store shelves without restriction. Labels for the generic drug must indicate the product is intended for use only by women ages 17 and older, but women will not need to show proof of age to purchase it.
Jessica Arons, president and chief executive officer of the Washington, DC-based Reproductive Health Technologies Project, praised the FDA’s action toward obtaining full over-the-counter status for emergency contraception. "EC can be used safely and effectively by people of all ages, and it should be available without unnecessary and arbitrary barriers," said Arons in a press statement accompanying the FDA action.
Cecile Richards, president of the New York City-based Planned Parenthood Federation of America, termed the FDA move as "a significant step forward for women’s health." "When a woman fears she might become pregnant after her contraceptive has failed or she has had unprotected sex, she needs fast access to emergency contraception, not delays at the pharmacy counter," said Richards in a prepared statement. "Having more than one kind of emergency contraception stocked on store shelves will make EC more accessible to everyone, and that means more women than ever will be able to prevent unintended pregnancy."
Dollars add up
Emergency contraceptive pills can be costly for women who pay out of pocket for them. Results of a July 2013 survey of some 400 pharmacies nationwide indicate the average price for Plan B One-Step at nearly $48, with generic EC product pricing at $41.1
Generic products include My Way, launched in February 2013 by Gavis Pharmaceuticals of Somerset, NJ, and Next Choice One Dose, sold by Actavis of Parsippany, NJ. Next Choice One Dose received FDA approval in July 2012.
Generic EC products will be able to drop the age limit in their labeling entirely when Teva loses its market exclusivity labeling for ages 16 and under on April 30, 2016. Age restrictions for Plan B One-Step were lifted in June 2013 when the United States dropped its appeal against an April 2013 court order to remove such restrictions. (To review the legal history, see the Contraceptive Technology Update articles "Appeal filed to delay unrestricted EC sales," July 2013, p. 79, and "U.S. drops age limits for Plan B One-Step," August 2013, p. 88.)
Will prices drop?
Moving generic products to the shelf might result in market competition that will drive down the price of EC overall, said Arons.
"We hope and expect that all manufacturers of generic EC products will submit applications with the suggested labeling to the FDA immediately," she said. "The sooner generic EC becomes available without point-of-sale restrictions, the sooner people will be able to purchase a more affordable, time-sensitive, back-up birth control option without delay."
With changes with the Affordable Care Act (ACA), particularly related to coverage of medications and supplements that became effective in 2014, remember that certain over-the-counter medications are covered at no cost when written as a prescription. For family planning patients who are enrolled in ACA-compliant plans, clinicians should write EC prescriptions so patients can obtain the drug at no cost, said Jeanne Conry, MD, PhD, president of the American College of Obstetricians and Gynecologists.
Keep in mind that the copper-T 380A intrauterine device (IUD) represents a safe, effective form of emergency contraception that provides long-acting reversible contraception. Compared to EC users who choose oral levonorgestrel, those who select the copper IUD have lower rates of pregnancy in the next year, results of 2013 study indicate.2 The prospective study followed women for one year after choosing the copper T380 IUD or oral levonorgestrel for EC. The study was powered to detect a 6% difference in pregnancy rates within the year after presenting for emergency contraception.
Of the 542 women who presented for EC, agreed to participate in the trial and met the inclusion criteria, 215 (40%) chose the copper IUD and 327 (60%) chose oral levonorgestrel. In the IUD group, 127 (59%) were nulligravid. IUD insertion failed in 42 women (19%). The one-year follow-up rate was 443/542 (82%); 64% of IUD users contacted at one year still had their IUDs in place.
The one-year cumulative pregnancy rate in women choosing the IUD was 6.5% vs. 12.2% in those choosing oral LNG [hazard ratio (HR) 0.53, 95% confidence interval (CI): 0.29-0.97, p=.041]. By type of EC method actually received, corresponding values were 5.2% for copper IUD users vs. 12.3% for EC pill users (HR 0.42, 95% CI: 0.20-0.85, p=.017). A multivariable logistic regression model controlling for demographic variables indicates that women who chose the IUD for EC had fewer pregnancies in the following year than those who chose oral LNG (HR 0.50, 95% CI: 0.26-0.96, p=.037). Greater use of the copper IUD for EC might lower rates of unintended pregnancy in high-risk women, researchers conclude.
- American Society for Emergency Contraception. The Cost of Emergency Contraception: Results from a Nationwide Survey. Accessed at http://bit.ly/Nag1Rm.
- Turok DK, Jacobson JC, Dermish AI, et al. Emergency contraception with a copper IUD or oral levonorgestrel: an observational study of 1-year pregnancy rates. Contraception 2013; doi: 10.1016/j.contraception.2013.11.010.
