A judge has ordered the Food and Drug Administration to allow the sale of emergency contraception—-also known as “Plan B” or “The Morning After Pill”—-to 17-year-olds. Previously, the emergency pill was offered over-the-counter only to customers aged 18 and older, and only to pharmacies that enforced the age rule by checking IDs.
U.S. District Judge Edward Korman had some harsh words for the Bush-run FDA in laying down his judgment, the Associated Press reports:
n a thorough denunciation of the Bush administration, U.S. District Judge Edward Korman blasted the FDA’s handling of the issue, saying it had “repeatedly and unreasonably” delayed issuing a decision on the medication.
The morning-after pill is a source of tension for social conservatives who held great sway in the Bush administration and who believe the pill is tantamount to abortion.
The ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions only took action to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.
“These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making,” Korman said. “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.”
According to the AP, “the FDA’s Advisory Committee voted 23 to 4 in 2003 to approve Plan B for over-the-counter status without age restrictions. However, out of nearly two dozen applications to move a prescription drug to over-the-counter status, the Plan B request was the only one not approved after the committee recommended it.” In 2006, the medication was made available over the counter, but only to adults.
Korman’s ruling, which must go into effect within 30 days, is a big step forward. But if the FDA approved the sale of the drug without age restrictions six years ago, and Judge Korman offered a scathing critique of the Bush administration’s handling of the medication, why is it now only approved for women aged 17-and-up? What about 16, 15, and 14-year-old girls? Why restrict the age at all?