Monday, November 14, 2005

Plan B and the GAO Report

Via this NARAL site, I took a look at the just released Government Accountability Office (.pdf) report Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual [you don't say!].

Of note (emphasis mine):

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.

There are no age-related marketing restrictions for safety reasons for any of the prescription or OTC contraceptives that FDA has approved, and FDA has not required pediatric studies for them. All FDA-approved OTC contraceptives are available to anyone, and all FDA-approved prescription contraceptives are available to anyone with a prescription. For hormonal contraceptives, FDA assumes that suppression of ovulation would be the same for any female after menarche,13 regardless of age. FDA did not identify any issues that would require age-related restrictions in its review of the original application for prescription Plan B, and prescription Plan B is available to women of any age.

In its comments on a draft of this report, FDA disagreed with three of our findings. First, FDA disagreed with our finding that the involvement of high-level management in the Plan B decision was unusual because their involvement is likely in high-profile and controversial regulatory decisions. Although we agree that high-level management involvement is more likely to occur with high-profile regulatory decisions, we found that the level of high-level management involvement for the Plan B decision was unusual for OTC switch applications. The other examples of high-level management involvement given to us by FDA officials during the course of our work involved decisions about the marketing of prescription drugs. Second, FDA disagreed with our discussion about when the decision to deny the switch application was made. We maintain that the draft report accurately noted that FDA officials gave us conflicting accounts about when they believed the not-approvable decision was made. Third, FDA disagreed with our finding that the Acting Director of CDER’s rationale for denying the application was novel and did not follow FDA‚’s traditional practices. We found that the Acting Director’s rationale was novel because it explicitly considered the differing levels of cognitive maturity of adolescents of different ages, and that, because of the Acting Director‚’s views about these differences in cognitive maturity, he concluded that it was inappropriate to extrapolate data related to risky sexual behavior from older to younger adolescents. The Acting Director acknowledged to us that considering adolescents’ cognitive development as a rationale for a not-approvable decision was unprecedented for an OTC application. In addition, other FDA officials told us that the agency had not previously considered whether younger adolescents would use a product differently than older adolescents.

Not to take anything away from these findings, but all one had to do to reach the exact same [obvious] conclusion was to read the medical literature. Think how much taxpayers money could have been saved.

In any case, NARAL's site also has a clock tracking the number of days since more than 70 organizations, including the American Nurses Association, the American Academy of Pediatrics, the American Public Health Association, and the Association of Reproductive Health Professionals, filed a citizen‚’s petition to request that the FDA switch certain emergency contraceptive drug products from prescription to over-the-counter status.

There's also a way to contact your representative to urge his/her support for the Maloney-Shays-Inslee-Crowley "Plan B for Plan B Act." (.pdf) This bill would give the FDA 30 days to approve or deny the application for the "morning-after pill" Plan B®. If the agency continues to drag its feet, the application is assumed to be approved....

For the record, I don't think politicians should have any say in a woman's medical decisions, period. This applies equally to Congress pressuring the FDA to reclassify condoms as special controls devices, outlawing made up medical procedures ("partial-birth" abortions), or passing bills to make Plan B available OTC.


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