EC: Progress made, but challenges remain
How has the emergency contraception (EC) landscape changed in the year after the Food and Drug Administration’s (FDA’s) approval of Plan B One-Step (Teva Women’s Health, North Wales, PA) emergency contraception for use without a prescription for all women of child-bearing potential?
EXECUTIVE SUMMARY
Availability of emergency contraception (EC) has broadened since the FDA ruled that generic EC could be sold on store shelves and would no longer require proof of age.
- Pill options include Plan B One-Step, Take Action. Next Choice One Dose, My Way, and After Pill. After Pill is available only through its online website and is priced at $20 per dose.
- Federal regulations do not require insurers to cover over-the-counter preventive products such as EC at no cost unless the consumer has a prescription. The Supreme Court decision allowing closely held corporations with a religious objection to exclude contraceptive services and methods in their employer-sponsored health plans puts no-cost coverage for prescription EC at risk for many women.
There have been several recent developments that serve to improve the availability of EC, according to the Washington, DC-based Reproductive Health Access Project. The FDA issued a letter in February 2014 indicating that generic EC could be sold on store shelves and would no longer require proof of age for purchase.
Women can chose to take Plan B One-Step, Take Action (Teva), Next Choice One Dose (Actavis, Parsippany, PA), My Way (Gavis Pharmaceuticals, Somerset, NJ) or AfterPill (Syzygy Healthcare Solutions, Westport, CT). AfterPill, a generic equivalent of Plan B One-Step, differs from other products in that it is only available online. It is sold at a price point of $20 per dose, compared to $48 on average for Plan B One-Step.
Lowering the price of the best-selling over-the-counter emergency contraceptive medicine to $20 will help make access to emergency birth control more affordable for women, said Syzygy spokesperson Alyson O’Mahoney in a press statement accompanying the drug’s July 2014 launch. Mahoney noted the ability to purchase AfterPill via a dedicated website (www.AfterPill.com) removes the risk of not finding EC at a local pharmacy and also affords a discreet way to obtain EC.
According to Syzygy officials, there are no purchase restrictions for AfterPill, and no proof of age is required. The product is an FDA-authorized, over-the-counter (OTC) product that can be purchased by any consumer regardless of age or gender. Its label indicates for use only by women 17 years of age or older, as mandated by the FDA, but there are no purchase restrictions, the company states.
An analogous product is the OTC Oxytrol product from Merck Consumer Products Co.(Whitehouse Station, NJ), note Syzygy officials. While it is indicated for the treatment of over-active bladder conditions among women 18 years of age or older, it also has no purchase restrictions.
Check coverage status
While more options might help drive down price of emergency contraception pills, access might be hampered for many women whose insurance policies do not cover OTC products. According to the Reproductive Health Access Project, federal Health and Human Services regulations do not require insurers to cover OTC preventive products such as EC at no cost unless the consumer has a prescription, and the June 2014 Supreme Court decision on contraceptive coverage puts no-cost coverage for prescription EC at risk for millions of women. On June 30, 2014, the U.S. Supreme Court issued a ruling that closely held corporations that assert a religious objection do not have to cover contraceptive services and methods in their employer-sponsored health plans as required under the Affordable Care Act.
The Reproductive Health Access Project is calling for action on three fronts:
- Support legislative and administrative fixes to the Supreme Court decision to ensure women receive the coverage they need for all forms of contraception, including EC.
- Advocate for an interpretation of the women’s preventive services section of the Affordable Care Act that would require no-cost coverage of any over-the-counter EC product without a prescription.
- Encourage market developments that will help to lower the price of EC so that cost does not remain a barrier to access.
Check store shelves
Have you checked your local drug store shelves to see if EC is available? Because Plan B One-Step became available for sale without age or point-of-sale restrictions in July 2013, retail and pharmacist response has been "confusing at best and non-compliant at worst," according to the Reproductive Health Access Project.
A survey completed in early 2014 by the Princeton, NJ-based American Society for Emergency Contraception found that only half of stores stocked Plan B One-Step on store shelves.1 Among the stores that did stock EC on the shelf, more than half of these displayed the product in a locked, portable box or in a fixed case that had to be unlocked by a store employee, survey respondents note.
While the February 2014 letter from the FDA indicated generics could be sold without requiring proof of age, the labels for existing generic products must be updated before the products can be moved to store shelves. This need has caused additional confusion about what products are available without proof of age and where they can be stocked, states the Reproductive Health Access Project.
Advocates should educate the public and retailers on the status of the various EC products and where they should be stocked. Also, advocates should seek accountability from retailers to ensure they stock EC in a manner that does not deter access and that removes unnecessary barriers.
While a great deal of progress has been made to improve and expand access to EC, financial and physical barriers and political threats to comprehensive access remain, said Jessica Arons, chief executive officer and president of the Reproductive Health Access Project in a statement on EC status. "Advocates and policymakers alike have a role in taking action to ensure access to basic preventive health care like EC," Arons noted.
Robert Hatcher, MD, MPH, professor emeritus of gynecology and obstetrics at Emory University School of Medicine in Atlanta, has a strong recommendation regarding emergency contraception. "Stop recommending emergency contraceptive pills until we have an oral emergency contraceptive with considerably higher effectiveness," states Hatcher. "Professor James Trussell speaks of the harsh reality’ of the fact that as taken today, emergency contraceptive pills have no global effect on women’s risk for an unintended pregnancy."
Today, the copper T 380A intrauterine device (IUD) (ParaGard, Teva North America, North Wales, PA) is by far the best approach to emergency contraception, and if acceptable to a woman, will provide her effective contraception for the next 10 to 12 years, notes Hatcher. Only one in 1,000 women receiving a Copper T IUD for emergency contraception becomes pregnant, Hatcher states.
- American Society for Emergency Contraception. Emergency Contraception Access Report. Accessed at http://bit.ly/
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