Plan B

This is unbelievable.

Andrew von Eschenbach, the Acting Commissioner of the FDA, claims Plan B is supposedly not safe for 16 year-olds (the age Barr was seeking as their lowest threshold for unsupervised use) but it is OK for 18 year old.

[via Letter to Joseph A. Carrado, M.Sc., R.Ph., July 31, 2006]:

We are now proceeding with further evaluation of your sNDA. We would like to meet with you as soon as practicable, and preferably within seven days, to discuss the status of your sNDA, including any necessary amendments. For example, your sNDA seeks approval for OTC use for women ages 16 and older. As we informed you in our August 26, 2005 letter, the Center for Drug Evaluation and Research concluded the available scientific data are insufficient to support the safe use of Plan B as an OTC product for everyone in that age group. Moreover, because of enforcement considerations, we believe that the appropriate age for OTC access is 18. Should you desire to proceed with your sNDA, you would need to amend it to seek approval for OTC status for women ages 18 and older. In addition, you would need to amend your sNDA with respect to packaging.

Is it scientifically possible for the body of an underage woman to change so dramatically in two years?

But the FDA doesn't stop at bogus scientific claims. It goes into the marketing and selling of the product : Barr Laboratories can only sell Plan B to pharmacies that will be willing to card buyers AND keep it behind the pharmacists' counter.

We would also like to discuss the details of the CARESM Program that you submitted with your sNDA. That program regards your proposed marketing, education, distribution, and monitoring for the OTC version of Plan B�. Specifically, we would like to learn more about your proposal to restrict distribution of Plan B to certain pharmacies, i.e., the OTC version of Plan B would not be available at gas stations, convenience stores, etc., but only to those pharmacies agreeing to (1) keep the OTC version of the drug behind the pharmacy counter and (2) dispense the drug only upon the production of a valid photo identification card establishing the age of the consumer. In particular, we would like to learn more about your plan to routinely monitor these pharmacies to make sure they comply with the restricted distribution plan. In addition, we are very interested in learning how you plan on enforcing the restrictions if a pharmacy fails to comply with them, e.g., whether the restrictions will be incorporated into the terms of a formal contract and, if so, what the terms of that contract (particularly those terms related to a breach) look like.