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NATIONAL POLITICS & POLICY | Judge Orders FDA To Reconsider Age Restrictions on Nonprescription Access To Plan B

NATIONAL POLITICS & POLICY | Judge Orders FDA To Reconsider Age Restrictions on Nonprescription Access To Plan B
[March 24, 2009]

A federal judge on Monday ordered FDA to allow nonprescription sales of the emergency contraceptive Plan B to women ages 17 and older -- a change to the current limit of age 18 -- and to "reconsider" its restrictions on selling the medicine without a prescription to anyone, the Wall Street Journal reports. Judge Edward Korman of the Eastern District of New York in his ruling criticized current and former FDA officials who he said had used "political considerations, delays and implausible justifications" to hinder nonprescription sales of the contraceptive for several years. According to the Journal, FDA has 30 days to take action to allow 17-year-olds to purchase Plan B. An FDA spokesperson said the agency is reviewing the judge's ruling (Mundy, Wall Street Journal, 3/24).

Plan B consists of two pills that can prevent pregnancy if administered within 72 hours of sexual intercourse, according to the New York Times. It has been available in the U.S. by prescription since 1999. In 2001, citing the time-sensitive nature of the drug, more than five dozen public health groups, with endorsements from the World Health Organization and the American Medical Association, asked FDA to make Plan B available without a prescription. The agency in 2006 decided to allow nonprescription sales to women ages 18 and older, requiring that pharmacies store the drug behind the counter as a way to enforce the age restrictions (Singer, New York Times, 3/24). According to the Washington Post, the delay led "to intense criticism that the agency was allowing politics to influence the decision." At the time, FDA said there was not enough safety data to approve the drug for women younger than age 18 and that pharmacists would not be able to enforce the age restrictions (Stein, Washington Post, 3/24).

In his ruling, Korman wrote that FDA had "acted in bad faith and in response to political pressure" and "repeatedly and unreasonably delayed issuing a decision on Plan B." The age restriction "lacks all credibility," Korman wrote, adding that the decision was based on "fanciful and wholly unsubstantiated 'enforcement' concerns" (McCullough, Philadelphia Inquirer, 3/24).

According to the Times, women's health advocates praised Korman's ruling (New York Times, 3/24). Susan Novak, a senior staff lawyer at the Center for Reproductive Rights, which filed the lawsuit against FDA, said, "The message is clear: The FDA has to put science first and leave politics at the door" (Washington Post, 3/24). Nancy Northup, president of the Center for Reproductive Rights, said the decision is 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" (New York Times, 3/24). Northup also said the decision is a "tremendous victory for all Americans who expect the government to safeguard public health" (Neumeister, AP/ 3/23). Susan Wood, former FDA director of women's health who in 2005 resigned in protest of the Plan B delays, said the decision to have FDA reconsider the restrictions signals hope that the Obama administration would allow the agency to act independently. Wood, currently a professor of public health at George Washington University, said there is an opportunity to "restore the scientific integrity of the FDA" (New York Times, 3/24). However, she noted that several officials involved in the FDA decision are still at the agency, including Janet Woodcock, head of the FDA drug approval office, and Steven Galson, acting surgeon general and assistant secretary of health (Washington Post, 3/24). Wood added, "What happened with Plan B demonstrated that the agency was off track, and was not being allowed to do its job properly." The decision is "telling the FDA to move forward with a focus on good science," Wood said (AP/, 3/23).

Some conservative groups raised concerns that increasing the availability of Plan B could promote sexual promiscuity. The conservative Family Research Council said in a statement that the decision would allow "some minor girls ... to obtain this drug without any guidance from a doctor and without any parental supervision" (New York Times, 3/24). Chris Gacek, a regulation expert with FRC, said Korman "has accepted lock, stock and barrel all of the claims of a political ideology promoting sexual license for teens." Gacek added that there is a "real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent" (AP/, 3/23). The New York State Catholic Conference, which opposes all nonprescription sales of Plan B, said lifting the age restrictions could lead to overuse of the drug as a primary method of birth control. Conference spokesperson Dennis Poust said it is "completely inappropriate" and "a scary situation when a judge who is not a doctor can overrule the FDA on the proper age when someone can take a medication" (Riley, Newsday, 3/24). Wendy Wright of the group Concerned Women for America said the decision "puts politics above women's health" and "intrudes into parents' ability to protect their minor daughters." Wright also questioned the effectiveness of EC and said making it more accessible "has not resulted in fewer pregnancies or abortions, as advocates promised it would" (Washington Post, 3/24).