No Morning After

The Food and Drug Administration's recent decision to refuse to make Plan B emergency contraceptive pills available over the counter is a terrible disservice to the public. The decision manifests a pattern of disregard for science from the current administration. There is unprecedented support for over-the-counter access to emergency contraception among the medical community and the public. The medical evidence overwhelmingly shows Plan B is safe, effective and appropriate for OTC use by women of all ages. This product's potential to reduce unintended pregnancy offers a significant public health benefit.

The Association of Reproductive Health Professionals—an international medical association representing more than 11,000 leading health care providers, researchers and educators in the field—is extremely distressed by the FDA's decision. Women's timely access to a safe and effective backup method of birth control has been denied based on political pressures—not the FDA's medical and scientific review process.

In denying over-the-counter availability, the FDA cited concerns about teens taking Plan B without clinical supervision. Opponents to approval expressed concerns that easier access may result in increased teen promiscuity, and may make teen girls subject to abuse by older men.

"These arguments against EC-OTC are red herrings," said Wayne Shields, ARHP president and CEO. "In fact, countries that allow over-the-counter access to EC and offer comprehensive sex education have far lower rates of teen pregnancy and abortion than we do. Teens tend to respond more responsibly when given responsibility. The teen pregnancy and abortion rate in the United States is more than five times higher than some European countries. We have the science that supports incorporating tools—such as EC over the counter—that can easily decrease our teen pregnancy and abortion rates in the United States. It's a no-brainer."

Plan B emergency contraceptive pills, also known as the morning-after pill, are an FDA-approved back-up contraceptive method effective for up to 72 hours after unprotected sex. The sooner it is taken, the more effective it is. Emergency contraception has the potential to prevent up to half of the 3 million unintended pregnancies in the United States each year. Recent studies have shown that some women may have difficulty obtaining timely access to emergency contraception, a health care professional or a pharmacy. Restricting its availability over the counter is not medically justified and creates a barrier to timely access.

On Feb. 13, 2004, the FDA issued a 90-day delay on its decision, despite an overwhelmingly strong recommendation in December 2003 by two of the FDA's expert advisory panels to approve EC for over-the-counter status. The advisory panel was unanimous in finding that medical evidence shows Plan B to be safe for use without a prescription. ARHP joined more than 70 of the leading health and medical organizations—including the American Medical Association and the American College of Obstetrics and Gynecology—in concluding that the medical evidence strongly supports Plan B becoming available over the counter.

The stakes for public health are too high to allow political maneuvering to circumvent a safe, effective and much-needed contraceptive option. The FDA has put politics before science, and ordinary women will suffer the consequences.

Felicia Stewart is a physcian, co-director of the Center for Reproductive Health Research & Policy at the University of California, San Francisco, and board member of the Association of Reproductive Health Professionals.

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