When taken within 72 hours after unprotected sex, the emergency contraceptive Plan B can reduce the risk of pregnancy by 89% – though the sooner it is taken, the better. Also known as the morning-after pill, Plan B consists of two 0.75 milligrams doses of levonorgestrel, the synthetic hormone that has been used in birth control pills for more than 35 years. On May 6, 2004, the Federal Drug Administration denied Plan B over-the-counter status, despite recommendations of approval from the Nonprescription Drugs Advisory Committee, the Advisory Committee for Reproductive Health, and FDA review officials. “The professional staff was pretty much entirely cut out of the last round of decision-making and didn’t have much impact on the first round,” said Dr. Susan Wood, who resigned from her post as director of the FDA’s Office of Women’s Health in protest of what can only be construed as politics trumping science. “As someone from the inside who is trained in science and someone who has been committed to good health policy and good women’s health policy for 15 years, this is not the way we should be doing business,” she said.
Dr. Wood is not alone in her assessment. According to a document published by the Government Accountability Office, entitled “Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual,” there are four main factors that are fishy. For starters, the directors of the offices that reviewed the application, who would “normally have been responsible for signing the Plan B action letter,” disagreed with the decision to the point that they did not sign their names to the nonapproval letter. Second, the GOA found that the FDA’s higher-ups were “more involved in the review of Plan B than in those of other OTC switch applications.” Third, the GOA says there are “conflicting accounts” of whether or not the decision was made before the reviews were even completed, and that “the rationale for the Acting Director’s decision was novel and did not follow FDA’s traditional practices.”
Also interesting is that the decision to deny OTC status was apparently based on the sole fact that the acting director found insufficient data on subjects younger than 14. But the GOA notes that, according to the deputy director of the Office of New Drugs, “there are no age-related marketing restrictions for any FDA-approved contraceptives, and FDA has not required any pediatric studies” for contraceptives in the past. Nevertheless, Plan B’s manufacturer Barr Pharmaceuticals reapplied for OTC status with an age restriction of 16 and older, in the hopes that the amended application would be suitable. Instead, it languished for months before the FDA officially opted to delay the decision indefinitely, a move that infuriated Wood.
And so Wood has taken it upon herself to get the word out, traveling the country speaking out on what she sees as a grave threat to science-based agencies. She’ll be in Austin for two events this week: The first, a free lecture entitled “The Controversy Over Emergency Contraception,” takes place Thursday, Jan. 19, 3:30-5pm at the Harry Ransom Center; the second is a fundraising luncheon for the National Abortion Rights Action League honoring three courageous and inspiring women: Wood, Shelby Knox, and Bettie Naylor, on Friday, Jan. 20, 11:30am-1pm at the Hilton Hotel Downtown. (See Community Listings for more event details.)
This article appears in January 20 • 2006.