The GAO probe found that high-level FDA officials were more involved than is usually the case in decisions to approve drugs for over-the-counter use. Also, investigators found conflicting accounts as to whether the decision to reject the application for OTC use was made before the agency's reviews were finished, the report said.
Also, three FDA directors who normally would have been responsible for approving the decision to reject the application did not do so because they disagreed with it, the report found.
The report said there were no age-related marketing restrictions for any prescription or OTC contraceptives previously approved by FDA, nor had the agency required pediatric studies for them. Also, "FDA identified no issues that would require age-related restrictions in the review of the original prescription Plan B new drug application," the GAO report said.
The FDA approved Plan B for prescription use in 1999.
Congressional critics have charged that FDA abandoned scientific principles in rejecting the OTC application, bowing instead to political pressure.
And that is precisely what is important, the Republicans made the decision not on science or established procedure, but on personal whim, that they then imposed upon everyone else in the nation.
Plan B FDA