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FDA Delays Approval of Morning-After Pill, Considers Restrictions

by NewStandard Staff

If the Federal Drug Administration approves the over-the-counter sale of Plan B contraceptive, it may require a minimum age and other restrictions; women’s groups and scientists say the FDA is letting politics influence its decision.

Apr. 10, 2004 –

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Women's rights activists and medical experts are calling on the Federal Drug Administration (FDA) to approve the over-the-counter sale of an emergency contraceptive without imposing any restriction on age or availability. Accusing the FDA of allowing political considerations to influence its decision, advocates of the contraceptive drug Plan B say the FDA’s decision whether to approve the drug should be based on sound scientific information and not election year politics.

Plan B is a drug that can prevent pregnancy if taken by a woman within about three days of intercourse.

In December 2003, an FDA advisory panel overwhelmingly recommended making Plan B available over-the-counter without a prescription, concluding that the drug was both effective and safe, HealthDay reports. But, according to the Washington Post, the FDA delayed making a decision on the drug’s approval for over-the-counter sale in February, asking the manufacturer for more information.

The Washington Post reports that the FDA is discussing a possible compromise with the drug’s distributor, Barr Laboratories, the company that submitted a request for over-the-counter approval. According to the Post, the proposed agreement would not keep with crucial elements of the FDA advisory panel’s December 2003 recommendations, which suggested the drug be sold over-the-counter without restrictions. The compromise reportedly may include prohibiting the drug’s over-the-counter sale to women under a minimum age and putting the drug behind the counter, requiring women to ask pharmacists for it.

Critics of the delay say the FDA is caving in to pressure from conservatives who oppose making Plan B more readily accessible. The Washington Post reports that at least 49 Republican members of Congress, joined by conservative women’s groups -- including the Concerned Women for America, a fundamentalist women’s organization working to bring Biblical principles into public policy -- have objected to selling the drug over-the-counter, citing concerns that it will lead to increased sexual promiscuity among teenagers and that the medical impact of the drug on adolescents are not well known.

"A young teenage girl needs to talk with a doctor about taking this pill, and a doctor needs the opportunity to examine her for STDs and to see if there might be [contraindications] with other drugs she's taking," Wendy Wright, policy director for Concerned Women for America, to the Post.

Plan B supporters counter that the safety of the drug for teenagers has already been examined and that the scientific research was taken into account by the FDA advisory panel, which voted 23 to 4 in favor of recommending approval without restrictions, reports the Post.

An April 8 editorial in The New England Journal of Medicine, a leading medical journal, blasted the FDA for allowing its decision making process to be influence by "political considerations" instead of scientific research. Evidence shows the emergency contraceptive is "safe and effective when available without a prescription," it said. The editorial, entitled "The FDA, Politics, and Plan B" stated, "A treatment for any other condition, from hangnail to headache to heart disease, with a similar record of safety and efficacy would be approved quickly."

The authors of the editorial, which include two members of the FDA advisory panel that recommended approval of the drug, further argued "evidence shows that the availability of emergency contraception does not result in a change in the usual behavior or contraceptive practices of the women who are its potential users." They also said the possible restrictions on the sale of the drug are "designed to intimidate women who require access to this medication."

Plan B, which consists of two doses of the hormone levonorgestrel, has been available as a prescription drug since 1999. The doses must be taken within 72 hours of sexual intercourse to be effective and the drugs efficacy is greater the sooner it is taken.

Advocates for over-the counter sales of the drug say making it more easily available will reduce unwanted pregnancies. They contend that delays caused by requiring women to see a doctor and obtain a prescription make it less effective and place an unnecessary burden on women without ready access to sympathetic health care provider.

"The women who will benefit most from the availability of emergency contraception are rape victims, young women, low-income women, and rural, isolated women -- and any woman who is unable to quickly reach a sympathetic physician to obtain a prescription," said Kim Gandy, President of the National Organization of Women (NOW), at a hearing concerning the drug. "We urge the FDA to remember these often overlooked women as it makes its decision," she said. NOW, a non-profit, non-partisan women’s rights organization, is currently calling on its members and other women’s rights activists to contact the FDA and express their support for over-the-counter sale of Plan B without restrictions.

In a statement to Reuters, a spokesperson for the FDA said, "the agency's decision on the application will be completely science-based."

According to the Post, similar emergency contraceptives are sold over-the-counter in 33 nations.

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