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Emergency Contraception Policy
Confused about EC Access?
For providers and consumers alike, confusion abounds about the availability of and accessibility to emergency contraception (EC). On April 22, 2009, the FDA decreased its previous age limitation from 18 to 17 and now allows consumers ages 17 and older to purchase Plan B over the counter (OTC).
There are now three FDA approved EC products available in the U.S. These products are “dual-labeled”-- they are available by both prescription and OTC with the same restrictions: women 16 years and younger need a prior a prescription from a doctor or clinic and consumers (women and men) 17 and older can get it OTC.
Plan B® One Step (Teva Pharmaceuticals, Inc.) is delivered as one tablet containing 1.5 mg levonorgestrel.
Next Choice™ (Watson Pharmaceuticals, Inc.) is a generic EC delivered in two tablets containing 1.5 mg levonorgestrel.
Plan B® (Teva Pharmaceuticals, Inc.) delivered in two tablets. also contains 1.5 mg levonorgestrel. Teva is no longer manufacturing or shipping Plan B and when existing supplies sell out, it will be replaced by Plan B® One Step.
The Reproductive Health Technologies Project has created a useful chart to compare the three EC products currently sold in the U.S. The chart is available at: www.rhtp.org/documents/PlanB-NextChoice-OneStepChart.pdf.
According to Teva’s report at the American Society for Emergency Contraception meeting in September 2009, current sales for EC products are estimated at about 70,000 units per week, 90% of which is sold OTC. This can be compared with sales of 17,000 units per week before the OTC change.
Although, we are excited that EC sales are up and there are more product options for women, we remain disappointed about the FDA’s continued unnecessary restrictions on young women’s EC access. Pharmacist-initiated prescriptions for EC that are currently available in nine states (AK, CA, HI, MA, ME, WA, VT, NH, NM) continue to be especially crucial to facilitate timely access for younger women, undocumented women, women without proof of age, or those needing a prescription for insurance coverage.
Through our programs, such as the Youth-Friendly Pharmacy Initiative, we will continue to educate about and promote pharmacies as a culturally-relevant access points for teens, women and men for sexual and reproductive health care.
Keep an eye out for another EC product. A new compound has been developed for EC use – ulipristal acetate – and is now commercially available in France, Germany and the United Kingdom, in anticipation of the forthcoming launch throughout the E.U. ellaOne® (HRA Pharma) maintains efficacy for five days after unprotected intercourse. ellaOne’s® safety and tolerability profile has been demonstrated to be comparable to that of levonorgestrel. Submission to the U.S. FDA is underway. In Singapore and Malaysia, HRA Pharma and Hyphens entered into a license and supply agreement to commercialize ella®.
Learn more about EC at Pharmacy Access Partnership, a center of PIWH.
Stay informed about emerging policy issues with PIWH Press Statements.
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