Reproductive Health Care Providers Outraged at Denial of Over-the-Counter Status for Plan B One-Step

Statement by Michael A. Thomas, MD, ARHP Board Chair

On behalf of the 12,000 reproductive health professionals represented by ARHP, I am gravely disappointed by Secretary Sebelius’ decision to deny the approval of Plan B® One-Step for over-the-counter access to women of all ages. The FDA and the Center for Drug Evaluation and Research (CDER) made a sound recommendation to remove the age restriction based on evidence-based science. Secretary Sebelius’ decision to overrule the FDA’s recommendation on this safe and effective medication is unprecedented and represents an unfortunate case of politics trumping science. Today’s situation is alarmingly reminiscent of the 2005 FDA EC decision which led Dr. Susan Wood to resign her leadership post in protest of the interference of ideology in scientific decision-making about emergency contraception. I am outraged that political influence seems to again be taking precedence over evidence-based science in policy decision-making.

Emergency contraception is a safe product that is by its nature very time-sensitive. ARHP members support removing barriers that limit access to contraceptive methods that can prevent unintended pregnancies and are adamant that policymakers make their policy decisions transparent and based on the best possible science.