Health Law

In 'truly bizarre' situation, FDA, DOJ and federal judge differ on 'Plan B' pill sale to teens

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In the latest round of a hard-fought political battle over the issue of whether the so-called morning-after birth control pill should be available without a prescription to 15- and 16-year-olds, a federal regulatory agency has told pharmacies they are free to sell one brand, Plan B One-Step, over the counter, to those in that age group.

But after the Food and Drug Administration’s OK on Tuesday, the U.S. Department of Justice remained silent on the issue and the Obama administration decided Wednesday to appeal a court ruling by U.S. District Judge Edward Korman, which the FDA sidestepped in its approach, according to the Associated Press and USA Today.

The judge had set a Monday deadline for the FDA to eliminate all age limits for the Plan B pill, which was to have been treated as an over-the-counter drug like aspirin. Instead, under the FDA approach, buyers would have to prove their age, the AP article reported.

“This is a truly bizarre and unprecedented situation,” said law professor Lewis A. Grossman of American University.

At this point, given the differing views of the FDA, the DOJ and the judge, it is doubtful whether pharmacies will offer Plan B over the counter to 15- and 16-year-olds at this time, the AP notes. Currently, the pill is available to those 17 and over without a prescription.

A New York Times (reg. req.) article last month described what the newspaper called an “acidly worded decision” by Judge Korman overruling the Obama administration’s “arbitrary, capricious and unreasonable” opposition to an earlier FDA decision to remove age restrictions for Plan B.

See also: (Dec. 2011): “HHS Secty Nixes FDA’s OK of Nonprescription Sale of Plan B Emergency Contraceptive to Teens Under 17”

Shots (NPR): “FDA OKs Prescription-Free Plan B Pill For Women 15 And Up”

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