MEDICINE AND HEALTH POLICY

MEDICINE AND HEALTH POLICY

Emergency contraception kept as prescription only in USA rate. When taken within 72 h of unprotected intercourse, levonorgestrel cuts the risk of pregnancy by up to 89%. In response to the FDA’s decision, Congresswoman Carolyn Maloney (Democrat, New York) introduced legislation requiring the agency to justify its decision. “A scientific 23–4 vote followed by a decision to reject that recommendation calls into question whether the FDA used science as its basis”, says Maloney. “If this decision was indeed based on science, not politics, then no one should object to this legislation. It is vital for the public health, and in this case women’s health, that the FDA is always using sound science, and is never subject to political pressure.” Conservatives strongly opposed increasing the accessibility to levonorgestrel, claiming that it would lead to greater promiscuity among teenagers. Steven Galson, acting director of the FDA’s Center

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he US Food and Drug Administration (FDA) has ruled against allowing the emergency contraceptive levonorgestrel, known as Plan B, to be sold over the counter. The decision was reached despite the FDA’s staff and two expert advisory panels recommending that it be approved. The American College of Obstetricians and Gynecologists (ACOG) called the FDA’s rejection “morally repugnant”, and pointed out that in December, 2003, two FDA expert advisory panels recommended approval of over the counter status by a 23–4 vote, after reviewing clinical data from about 40 studies. It is uncommon for the agency to go against the recommendations of both its own reviewers and an expert panel when making a decision. ACOG and other organisations have estimated that improving access to emergency contraceptives could reduce the US abortion

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Pharmacies cannot sell emergency contraception over the counter

for Drug Evaluation and Research, denied the decision was politically motivated. In the non-approval letter sent to Barr Laboratories, which distributes levonorgestrel, the FDA stated that Barr’s current application had not provided enough information to ensure that the drug could be safely used by those

aged 16 and under. The FDA gave Barr several options to gain future approval, including providing extra information on a plan to make the drug available over the counter to women aged 16 and over, and by prescription only for younger teens. Roxanne Nelson

Chile agrees to emergency contraception for rape victims he Chilean government’s decision to distribute the emergency contraceptive levonorgestrel to rape victims has provoked resistance from some local authorities opposed to the policy. According to the health ministry’s newly issued Clinical Guide for the Care of the Victims of Sexual Violence, public medical centres across the country should provide levonorgestrel free of charge to all women who claim to have been raped. These centres are run by local councils and some mayors have announced they would prevent the distribution of the pill within their jurisdiction. “In recent weeks, this [decision] has produced a tremendous debate in Chile; every day there are discussions on television, and letters and interviews in the press”, said Soledad Díaz, board member of the Chilean Institute for Reproductive Medicine, Santiago. Controversy over levonorgestrel dates

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back to 2001, when the Institute of Public Health first authorised its sale in Chile. The official position of the Catholic Church is that the pill is abortive and that its use constitutes murder. Now, the Archbishop of Santiago, Cardinal Francisco Javier Errázuriz has called upon all Catholic mayors to disobey the guidance. The Archbishop of Concepción, Antonio Moreno compared distribution of the pill to rape victims with Nazi and Stalinist atrocities and is organising a march against the measure. “This is a clear attempt to legalise abortion surreptitiously”, says Marta Ehlers, mayor of the Santiago borough Lo Barnechea. She believes the pill’s use compounds the trauma suffered by raped women. “I would rather resign than compromise the existence of unprotected beings.” Meanwhile, the government warned of possible budget cuts to municipalities whose mayors

THE LANCET • Vol 363 • May 22, 2004 • www.thelancet.com

refuse to implement the policy. The pill is currently available at chemists under medical prescription. The government has said that the new policy is an attempt to correct inequalities in access to the pill. Under prescription levonorgestrel costs 5800 to 8000 pesos (US$8–11). Poor women can’t afford it”, says Benedicta Aravena, a spokesperson for the Women’s Health Forum, Santiago. “While lawyers argue about whether a mayor’s conscience should be allowed to prevent the application of public health measures, an encouraging aspect of this rumpus is that science is having an impact on public policy debates”, says Díaz. “Opinion polls show over 80% support for emergency contraception. It will be interesting to see what impact this has on the forthcoming local elections.” Claudia Orellana

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