Judge orders change to Plan B age limit
FDA blasted for barring access for 17-year-olds
NEW YORK – The Food and Drug Administration let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication.
In 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 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.”
The drug is marketed by Montvale, N.J.-based Barr Pharmaceuticals Inc. as Plan B. Korman ordered the FDA to permit Barr Pharmaceuticals to make Plan B available to 17-year-olds without a prescription under the same conditions as Plan B is now available to women over the age of 18. He said his order must be complied with within 30 days.
The FDA said it is reviewing the judge’s decision. Women’s groups said it’s unlikely that the Obama administration would appeal. Social conservatives decried the ruling.
The conservative Family Research Council said the judge’s decision bowed to ideological pressure from the left.
“Judge Korman has accepted lock, stock and barrel all of the claims of a political ideology promoting sexual license for teens,” said Chris Gacek, a regulation expert with the group.
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