DOJ appeals expanded access to emergency contraceptives News
DOJ appeals expanded access to emergency contraceptives
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[JURIST] The US Department of Justice (DOJ) [official website] on Wednesday appealed an April decision [JURIST report] ordering the US Food and Drug Administration (FDA) [official website] to make emergency contraceptives including Plan B [JURIST news archive] available without a prescription to women of all ages. In 2005 organizations and individuals concerned with women’s health filed suit in the US District Court for the Eastern District of New York [official website] in pursuit of expanded access to the drugs, including over the counter (OTC) availability regardless of age. The judge ruled in their favor, but in December 2011 the Secretary of the Department of Health and Human Services (HHS) [official website], Kathleen Sebelius [HHS profile], intervened to block the ruling as it related to minors, citing inadequate evidence concerning adverse health effects. In April the district court overruled Sebelius’ “unprecedented” action, ruling that her intervention and the FDA’s subsequent compliance amounted to an “arbitrary, capricious, and unreasonable” response to the order. In addition, the judge found that the prescription requirement for adolescents under age 16 was “unjustified and burdensome.” On Tuesday, the FDA announced that the drugs would soon be available without prescriptions in response to the April decision. Just one day later, the DOJ challenged the court order [NYT report], claiming that the judge overstepped his legal authority.

Plan B has been the subject of considerable legislative and judicial activity since the FDA approved nonprescription access to the drug in 2006. In September the Appellate Court of Illinois ruled [JURIST report] that Illinois cannot force pharmacists to fill prescriptions for emergency contraceptives if they have religious objections to these drugs. In February 2012 a federal judge ruled [JURIST report] that a Washington law requiring pharmacists to dispense Plan B violated pharmacists’ freedom of religion rights. In 2009 the US District Court for the Eastern District of New York overturned [JURIST report] the FDA’s decision to limit Plan B to women 18 years or older. The court ordered the FDA to make Plan B available to 17-year-olds without a prescription. In March 2008, a federal judge in the US District Court of the District of Columbia dismissed [JURIST report] a lawsuit brought by a physicians’ group against the FDA seeking to overturn approval of the OTC sale of Plan B. In November 2007, a federal judge suspended [JURIST report] a Washington state law that would have required pharmacists to dispense the Plan B pill. In October 2007, Illinois pharmacists considered a settlement [JURIST report] to a dispute over a state law that would have required them to dispense the Plan B pill regardless of their moral objections to the contraception. Plan B contains levonorgestrel, a synthetic hormone that immobilizes sperm, reduces the number of sperm cells in the uterine cavity and prevents further sperm from entering the uterine cavity. The hormone can delay or prevent ovulation from occurring and is most effective when taken immediately after unprotected intercourse.