March 24, 2009

Judge Tells FDA to Make Plan B Available Over-the-Counter to 17 Year Olds, and to Consider Removing All Restrictions

Good news, via The New York Times:

A federal judge ordered the Food and Drug Administration on Monday to make the Plan B morning-after birth control pill available without prescription to women as young as 17.

The judge ruled that the agency had improperly bowed to political pressure from the Bush administration in 2006 when it set 18 as the age limit.

The agency has 30 days to comply with the order, in which the judge also urged the agency to consider removing all restrictions on over-the-counter sales of Plan B. The drug consists of two pills that prevent conception if taken within 72 hours of sexual intercourse.*

Nancy Northup, president of the Center for Reproductive Rights, which sued the FDA on behalf of women’s health organizations and individuals, called the ruling “a complete vindication of the argument that reproductive rights advocates have been making for years, that in the Bush administration it was politics, not science, driving decisions around women’s health.”

Plan B has been available in the United States since 1999, but originally it was only by prescription. It took until 2006 for the FDA to approve over-the-counter sales to women age 18 and over, meaning it must be stocked behind the pharmacy counter and women have to show proof of age. This makes it difficult for some women, including undocumented immigrants, to easily obtain the pills when needed.

In his 52-page ruling, Judge Edward R. Korman of Federal District Court in New York concluded that “no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription,” and “FDA officials and staff both agreed that 17 years olds can use Plan B safely without a prescription.”

Korman said the FDA’s decision was “not the result of reasoned and good faith agency decision-making.” He cited FDA officials for  improperly communicating with White House officials about Plan B and stacking the expert panel charged with the drug’s review with people who hold anti-abortion views. The FDA also ignored safety conclusions reached by its own advisory panel.

In a piece published last week at the Huffington Post, Northrup outlines the byzantine journey of Plan B’s application for over-the-counter status and describes what was learned during the trial:

[M]onths of testimony in the federal case uncovered a web of deceit behind-the-scenes — replete with high-level FDA officials kowtowing to outside political influence, circumventing agency regulations, and ultimately, conspiring to grant only limited access to Plan B.

Court testimony revealed that one official confessed to his coworker that he had to reject the Plan B application for fear of losing his job. Another told a colleague that the plan was for the agency to postpone making any decision on the drug for as long as possible, and when push came to shove, approve it with an age restriction — all in order to “appease the [Bush] administration’s constituents.”

Susan Wood, the former FDA director of women’s health who resigned in 2005 to protest the delays over approving Plan B, told the Times that now there is a new chance to “restore the scientific integrity of the FDA.”

Plus: Need more information about EC, or wondering if your pharmacy stocks it? Check out the Emergency Contraception website, an independent, peer-reviewed resource operated by the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals.

*Up to 120 hours after sex has been found to be just as effective.


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