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.
U.S. District Judge Edward Korman blasted the FDA's handling of the issue during the Bush administration, saying it had "repeatedly and unreasonably" delayed issuing a decision on the medication, marketed by Montvale, N.J.-based Barr Pharmaceuticals Inc. as Plan B.
Korman's ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions took action only 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."
Is sanity returning?