A federal court yesterday called on the FDA to do the right thing and revisit its politically motivated decision to unnecessarily restrict access to the emergency contraceptive Plan B. Often referred to as the “morning-after pill,” Plan B is a concentrated dose of the birth control pills millions of women take every day. And as yesterday’s court duly noted, the science is clear: women of all ages do not need a prescription to safely and effectively use Plan B to prevent pregnancy.
The story of Plan B is a long one, filled with, as the court puts it, “repeated and unreasonable delays,” “political considerations,” and “implausible justifications for decision-making.” In 2001, a group of 70 medical and public health organizations filed a petition with the FDA to make Plan B available without a prescription. The approval process was unlike any in recent FDA history. An aberration not missed by yesterday’s court:
FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application; the FDA's denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner — at the behest of political actors — decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.
Thwarting science and their own protocols, when the FDA finally decided to allow pharmacies to sell Plan B without a prescription, they limited access to women 18 and older with government-issued proof of age. For everyone else — teens under the age of 18 and women without government-issued proof of age — emergency contraception would continue to be available only with a prescription.
Yesterday, federal Judge Edward Korman held that "the FDA's decision was not the result of good faith and reasoned agency decision-making" because of "improper political interference" and departure from standard FDA policies. It ordered the FDA to expand over the counter access to 17 year olds and to reconsider its decision requiring any age restriction.
This decision helps restore the American value of scientific integrity in our government. The FDA can again be an advocate for increasing access to health care, rather than an enforcer of political ideology at the expense of women's health.
However, this is only the first step. More work is needed to make sure that all women have true access to emergency contraception. Even if the FDA makes Plan B available to all women without a prescription, we remain concerned about the high cost of over-the-counter emergency contraception. Most state Medicaid plans, for example, currently don't cover Plan B, meaning that many low-income women who rely on Medicaid for their health care needs currently can't afford access. And with the mounting cost of health care in general coupled with our tough economic times, more and more women — many of whom don't qualify for Medicaid — will find it difficult if not impossible to cover the costs of Plan B when they need it. Yesterday's court decision has given us the opportunity not only to put science and health care back into the FDA decision making process, but to simultaneously reconsider ways to make Plan B accessible and affordable for all women who need it.
— Sondra Goldschein, Director of State Advocacy, ACLU Reproductive Freedom Project and Vania Leveille, Legislative Counsel, ACLU Washington Legislative Office