Federal judge orders FDA to remove Plan B contraceptive age requirement

[JURIST] A judge for the US District Court for the Eastern District of New York [official website] on Friday ruled [opinion, PDF] that the Food and Drug Administration's (FDA) [official website] Plan B [official website] emergency contraception prescription requirement for adolescents under age 16 was "unjustified and burdensome." In 30 days women of all ages can access the over-the-counter (OTC) emergency contraceptive. According to the court, the standards for aspirin, contraceptives and any other OTC drugs are the same. Availability is dependent upon whether the consumer understands hows to use the drug "safely and effectively." Evidence exhibited that adolescents aged 13-16 were capable of understanding and using the contraceptive correctly, therefore making the age requirement unnecessary. The court further stated that "the obstructions in the path of those adolescents in obtaining levonorgestrel-based emergency contraceptives under the current behind-the-counter regime have the practical effect of making the contraceptive unavailable without a doctor's prescription." A study revealed that misinformation and difficulty finding a doctor impeded young women and low-income women from obtaining the drug.

The Plan B contraceptive has been the subject of considerable legislative and judicial activity since winning approval [JURIST report] from the FDA in 2006. 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.

 

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