Plan B: Politics Over Science


Don't expect any confetti and balloons or in-depth media analyses greeting the first anniversary of the Food and Drug Administration (FDA) decision to grant over-the-counter (OTC) status to Plan B emergency contraception. Nor should you expect the FDA to issue any formal statement about the historic anniversary. Certainly, this is not due to a lack of material. After all, Plan B is by far one of the most studied and written-about products in FDA history – with volumes of scientific and medical data about its use and effectiveness.

The fanfare won't happen because women's reproductive health continues to be mired in politics rather than addressed with responsible public policy solutions. But we can't afford to forget the long road to OTC status for Plan B – it's a telling case study in the politics of women's reproductive health.

The August 24, 2006, Plan B OTC decision marked the end of a three-year delay that many of the most prestigious medical associations agreed set a disturbing precedent at the FDA of putting politics over science. In 2005, the FDA's foot-dragging over a Plan B decision prompted its top officer on women's health to resign in protest. Dr. Susan Wood's resignation made national headlines – effectively highlighting the controversy over women's access to birth control. Dr. Wood told CBS's "60 Minutes" that the FDA ignored science by denying OTC access to Plan B.

For Dr. Wood and many other experts, the science is simple: Plan B is as safe as regular birth control and poses no threat to a woman's health – at any age. The politics is transparent: the Bush administration opposed OTC status for Plan B and pressured the FDA not to approve it. Although the FDA denied any interference from the White House, it approved Plan B as a nonprescription product with a major stipulation: young women (17 and under) would still need a prescription to get Plan B – a restriction President Bush publicly endorsed just days prior to the FDA OTC decision.

The heavy hand of the White House in private medical decisions continues to be problematic. Former Surgeon General Richard Carmona told the U.S. House Committee on Oversight and Reform as recently as July 2007 that the Bush administration had blocked him from addressing numerous public health issues, including emergency contraception.

Despite these roadblocks, it appears that consumers are taking advantage of Plan B's OTC status. According to Plan B manufacturer Barr Pharmaceuticals, Plan B sales have doubled over the past year and are expected to reach $80 million in this year alone.

Still, more documentation is needed to determine the impact of the FDA restrictions on access for millions of women who must still obtain a prescription to get Plan B, including Medicaid enrollees in most states, and women without proof of age. Additionally, we need to ensure that pharmacists and other healthcare providers are adequately trained and educated to ensure that women receive timely access to Plan B, despite FDA restrictions.

Unintended pregnancy remains a serious public health issue in the U.S., with three million unplanned pregnancies occurring each year. As we face a U.S. Supreme Court hostile toward women's access to the full range of reproductive health options, we cannot afford an apathetic public. We must recognize that access to Plan B represents an important option for women in preventing unintended pregnancy. Plan B works and women of all ages should have unfettered access to it. Let's hope that next year, as we look back at year two of the FDA's Plan B OTC decision, restrictions for young women and poor women won't still be an issue.

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