Judge orders FDA to allow over-the-counter availability of Plan B to 17-year-olds
FDA

The Food and Drug Administration decision of restricting the over-the-counter availability of the Plan B morning-after pill to the 17-year-olds has been denounced by Eastern District of New York Judge Edward R. Korman.

Plan B, a synthetic hormone that helps block unwanted pregnancy when taken within 72 hours of sexual intercourse, has no alarming side-effects, and is available without prescription "virtually all major industrialized" countries.

Noting that the FDA's restrictive decision with regard to the emergency contraceptive was affected by inappropriate political influence and was against the agency's own policies, Korman ordered the agency to allow Plan B manufacturer - the Montvale, New Jersey-based Barr Pharmaceuticals Inc - to make the medication available without prescription to the 17-year-olds.

Korman, who blasted the FDA "repeatedly and unreasonably" causing a delay in issuing a decision on the medication, said that his order must be abided by within a month. He also asked FDA to think about making the medication available to adolescents less than 17 years.

In his ruling, Korman said: "The political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making. Indeed, the record is clear that the FDA's course of conduct regarding Plan B departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use."

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