That's the conclusion of the non-partisan General Accounting Government Accountability Office's report (.pdf), whose headline reads: "FOOD AND DRUG ADMINISTRATION Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual."

On page 5:

While FDA followed its general procedures for considering the application, four aspects of FDA’s review process were unusual. First, the Directors of the Offices of Drug Evaluation III and V, who would normally have been responsible for signing the Plan B action letter, disagreed with the decision and did not sign the not-approvable letter for Plan B. The Director of the Office of New Drugs also disagreed and did not sign the letter. Second, FDA’s high-level management was more involved in the review of Plan B than in those of other OTC switch applications. For example, FDA review staff told us that they were told early in the review process that the decision would be made by high-level management. Third, as documented in the reviews of FDA staff and in our interviews with FDA officials, there are conflicting accounts of whether the decision to not approve the application was made before the reviews were completed. Fourth, the rationale for the Acting Director of CDER’s decision was novel and did not follow FDA’s traditional practices. Specifically, the Acting Director was concerned about the potential impact that the OTC marketing of Plan B would have on the propensity for younger adolescents to engage in unsafe sexual behaviors because of their lack of cognitive maturity compared to older adolescents. He also stated that it was invalid to extrapolate data from older to younger adolescents in this case. FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency has considered it scientifically appropriate to extrapolate data from older to younger adolescents.

The decision to not approve the Plan B OTC switch application was not typical of the other 67 prescription-to-OTC switch decisions made from 1994 through 2004. FDA’s joint advisory committee considered 23 OTC switch applications during this period; the Plan B OTC switch application was the only 1 of those 23 that was not approved after the joint committee voted to recommend approval of the application. Also, the Plan B action letter was the only one signed by the Director of CDER, in this case the Acting Director of CDER, instead of the directors of the offices or divisions that reviewed the application, who would normally sign an action letter.

Clearly there's an agenda here that has nothing to do with public safety or any actual scientifically-based concern for public health.

Why the ideologues in favor of criminalizing abortion are even obsessing over Plan B is questionable, as Plan B does not cause abortions -- in fact, it prevents fertilization -- aka conception. Pages 12-13:

Research has shown that levonorgestrel-only hormonal emergency contraception, such as Plan B, interferes with prefertilization events. It reduces the number of sperm cells in the uterine cavity, immobilizes sperm, and impedes further passage of sperm cells into the uterine cavity. In addition, levonorgestrel has the capacity to delay or prevent ovulation from occurring.

ECPs have not been shown to cause a postfertilization event—a change in the uterus that could interfere with implantation of a fertilized egg. Some researchers argue that an interference with the implantation of a fertilized egg is unlikely to happen because progestins, whether natural or synthetic, help to sustain pregnancy. In addition, there is no evidence that one burst of levonorgestrel without estrogen can prevent implantation. However, researchers have concluded that the possibility of a postfertilization event cannot be ruled out, noting that it would be unethical and logistically difficult to conduct the necessary research. ECPs, including Plan B, do not interfere with an established pregnancy.

Auto accidents can't be ruled out, either, but I don't see any of these folks crying out for the banning of automobiles.

So the radical right-wing zealots oppose Plan B over a hypothetical that has never been shown to occur. Yet they scream anyway.

Maybe they oppose Plan B because the drug does not prevent copulation. After all, copulation is the reason women are supposed to be punished, right? Maybe the insertion of the penis into the vagina is when life supposedly begins now? After all, if their goal is to outlaw extra-marital sex -- and, for those radicals who oppose birth control for married women, even marital sex -- then their rationale would have to push the beginning life life back not only before birth, to before conception to simply the gleam in the man's eye.

Read the whole report (.pdf). It's pretty damning indeed.

And ask yourself: How many unwanted pregnancies could have been prevented while the government kowtowed to the irrational agenda of the radical right?

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