No Plan B for over the counter contraceptive

By Janice Hopkins Tanne New York

Family planning groups, women's organisations, obstetricians and gynaecologists, legislators, and national newspapers in the United States recently protested at the Food and Drug Administration's (FDA's) refusal to permit sales over the counter (without a prescription) of an emergency contraceptive.

In making its decision the FDA over-ruled its own scientific advisory committee and its professional staff.

Many experts said it was an attack on contraception by the antiabortion Bush administration. But Dr Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, defended the decision, saying it was not politically motivated. Conservative groups said that the contraceptive, called Plan B, would have increased rates of pregnancy among teenagers and that the drug was dangerous.

The FDA rejected the application of the drug company Barr Research for over the counter status for its product, saying the company had not shown that adolescent women could understand the product instructions. The FDA has never previously required such information before granting over the counter status.

Its reasons were dismissed as "bogus" and "a red herring" by Dr Scott Spear, an associate professor of paediatrics at the University of Wisconsin-Madison and director of health services for the university's 40 000 students.

Plan B has been available on prescription in the United States for several years and is available over the counter in 33 countries.

Susanne Martinez, Planned Parenthood's vice president for public policy, said, "The FDA's scientific advisory committee voted overwhelmingly--23 to four--for OTC [over the counter] status. The FDA's professional staff agreed with the committee. Both were over-ruled." She could not remember any time the FDA over-ruled its expert committees; neither could former FDA commissioners.

The United States has one of the world's highest rates of teenage pregnancy and unplanned pregnancy.

Forty one members of the House of Representatives asked the FDA to reconsider. Some asked FDA officials to resign. Others asked the General Accounting Office, a non-partisan arm of Congress, to investigate the FDA's decision.

The American College of Obstetricians and Gynecologists called the FDA's decision "morally repugnant."

In an editorial the New York Times called the FDA's decision "politically motivated".



studentBMJ 2004;12:221-264 June ISSN 0966-6494