SMRs and AMRs

Monday, March 23, 2009

Judge Orders FDA to Reconsider Limits on Morning-After Pill for Minors

By Rob Stein
Washington Post Staff Writer
Monday, March 23, 2009

A federal court today ordered the Food and Drug Administration to reconsider the agency's controversial decision limiting non-prescription access to the morning-after pill Plan B to women age 18 and older.

U.S. District Judge Edward R. Korman ordered the FDA to make Plan B available to women age 17 and older within 30 days and to reconsider whether to make the drug available to women of all ages without a prescription.

In his 52-page decision, Korman said 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 from prescription to non-prescription use."

Critics of the FDA's position hailed the ruling.

(More here.)

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