June 28, 2013

Ask the FDA to Approve *All* Emergency Contraception Pills for OTC Access

Many readers are already aware of the developments over the past few months regarding prescription-free access to emergency contraception,  including the FDA’s recent approval of Plan B One Step with no age restrictions.

While unrestricted access to Plan B One-Step is great news for women and girls needing timely access to emergency contraception, there are concerns that the cost — between $35 and $60 — puts it out of reach for many users. Unfortunately, the FDA’s approval focused specifically on that one product, and left out generic two-pill versions that would likely cost less.

In his response to the FDA’s plan, U.S. District Judge Edward R. Korman noted that he “did not order the defendants to make the brand-name Plan B One-Step available over-the-counter without age or point-of-sale restrictions,” but instead instructed the FDA “to make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.”

Korman had allowed, however, that if the FDA believed there was a real difference between the newer one-pill and two-pill products, it could limit its approval to the one-pill form. The FDA did just that, citing the need for additional studies to determine whether women under age 17 could read a two-pill label and correctly take the pills 12 hours apart.

In his initial ruling, Korman said that such data was already available and there is very little risk in varying the 12-hour timing, but added that “if the FDA actually believes there is any significant difference,” it could just approve the one pill version. In his more recent response, Korman called the FDA’s claims “far fetched.”

Our Bodies Ourselves and other women’s health advocates disagree with the FDA’s finding, noting that there is a lack of scientific evidence for the distinction between the one-pill and the two-pill versions.

The National Women’s Health Network has posted a letter, which we encourage you to sign, asking FDA Commissioner Peggy Hamburg to remove  barriers to more affordable, generic EC products. It reads in part:

The FDA’s own scientists concluded that age restrictions were unnecessary for all EC products, and the medical community consensus supports that as well. We urge you to allow the makers of generic EC products to revise their labels to make them available without age or point of sale restrictions.

Leaving lower-cost generics behind the pharmacy counter will disproportionately affect low-income women, racial minorities, and younger women for whom cost is a greater barrier. Withholding more affordable generic options from women could contribute to persistently high unintended pregnancy rates in the United States as compared to other developed countries and to adverse health outcomes among vulnerable populations.

All women deserve access to emergency contraception. Please add your name to the FDA letter today!

Plus: For tips on saving money on the cost of OTC emergency contraception, visit the Emergency Contraception website, a project of the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals.

And, if you have health insurance coverage, learn more about getting a prescription for emergency contraception, which may reduce the cost to nothing.


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