DRUG REGULATION: Plan B: A Collision of Science and Politics

Read the full article in Science magazine (subscripriont required.)/a>: Couzin 310 (5745): 38 -- Science

"Researchers see ideology trumping sound science"

On 26 August, after more than 2 years of deliberation, and a contentious advisory committee meeting, the U.S. Food and Drug Administration (FDA) put off indefinitely a ruling on the application to move Plan B to over the counter (OTC) status.

"The problem, agency officials said, was a dearth of information on whether the drug, approved for prescription use in 1999 and widely available in European pharmacies, would negatively influence the sexual behavior or health of adolescents. FDA was unsure how to restrict the drug's OTC status to older age groups." (Science notes, "Emergency contraception is available OTC or from a pharmacist in 39 countries. In France, it's provided by school nurses in every senior and junior high school.")

Plan B, or levonorgestrel, is a "morning-after" pill. It is a progestin-only pill that interferes with ovulation and perhaps with fertilization. Its effectiveness declines with time, which argues for making it rapidly available. Plan B is distinct from, but sometimes confused with RU-486, a drug that chemically induces an abortion in the early weeks of pregnancy. Both drugs are sold to be taken after unprotected intercourse to prevent pregnancy.

Two FDA advisory committees--on Reproductive Health Drugs and Nonprescription Drugs--together considered the application for OTC status in December 2003. Most members agreed that it met the OTC criteria: First, the drug is designed for an event (unprotected intercourse) that a patient can easily diagnose. Second, Plan B doesn't come with undue monitoring requirements, such as regular blood tests. And finally, side effects are few and can normally be managed without help from a doctor. The advisory committees voted unanimously that the drug was safe for OTC use.

Several studies published in peer reviewed journals have indicated that the availability of the pill does not affect sexual behavior of young women. Opponents' concern that frequent use of the drug might have long-term phsical effects on young women is apparently not widely shared by those specializing in female reproductive biology, and runs counter to FDA's own earlier rulings. In any case, studies suggest that even when they have the drug available, women don't tend to use it often.

"By 2004, the American Academy of Pediatrics, the Society for Adolescent Medicine, and the American College of Obstetricians and Gynecologists had all expressed their support for making Plan B available OTC.....An internal memo in April 2004, from John Jenkins, head of FDA's Office of New Drugs, notes that 'both [FDA] divisions and offices responsible for this application have recommended approval.' Jenkins concurred with that assessment and added his own support for Barr's application."

"The head of FDA's Office of Women's Health, Susan Wood, resigned and publicly stated her disagreement with the Plan B decision. On 22 September, a New England Journal of Medicine editorial written by the journal's editor and two members of the two FDA advisory committees that voted in favor of the shift, citing the drug's safety, proclaimed that FDA's recent actions 'have made a mockery of the process of evaluating scientific evidence.'"

FDA commissioner Lester Crawford made the announcment that Plan B's OCT status would not be approved in August . Senators Hillary Clinton (D-NY) and Patty Murray (D-WA) had voted to confirm Crawford as Commissioner in July only after he promised a quick decision on Plan B. In late September, Crawford resigned suddenly from the FDA post.