The FDA was wearing Republican-colored glasses when it barred teenage girls from the morning-after contraceptive Plan B, a federal judge ruled yesterday. U.S. District Judge Edward Korman lambasted the agency for putting politics above public health and ordered FDA to let 17-year-olds have access to the drug, known as Plan B.
No one is as cognizant of Plan B's many delays and setbacks as the executives at Barr Pharmaceuticals, which markets the drug. But Korman's ruling pointed out the FDA's repeated and "unreasonabl[e]" procrastination as it put off issuing a decision on the drug. The agency held off on ruling whether Plan B could be converted to non-prescription use, only acting when its delays in turn delayed the confirmation of FDA officials. And it ignored the recommendation of its expert advisory committee and of its own scientific review staff.
"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 (as quoted by the Associated Press). "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 Assistant U.S. Attorney on the case said his office is "studying the decision and evaluating options." Given the fact that the administration has changed in the interim, the likelihood of an appeal seems small. But the judge's ruling has already set off a firestorm of protest from Plan B's critics. So we'll have to wait and see.
- read the AP story