2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC2204
Submitter : Dr. John Buysman Date & Time: 10/31/2005 06:10:28
Organization : Self
Category : Health Professional
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
There is a comment memo at end of this form. Please see. Thank You.

I work professionally in cardiology research, but on my own time I research teen sexuality issues, write study modules on sexual responsibilities, and occasionally speak to groups of teenagers.

I recommend against OTC status because Plan-B is inadequately labeled and inappropriately promoted. For a subset of users this will lead to life- long psychological discomfort.

Nearly all the teens who use Plan-B don't have a clue how it works. When they get older and form their own moral positions on abortion, and learn how the drug works, some will conclude that they might have had the equivalent of an abortion. To them, preventing an already fertilized egg from implanting is equivalent to abortion. Those who believe this way will be left with a life-long psychological discomfort over the uncertainty of not knowing if they had a fertilized egg or not.

Proponents of Plan B are quick to point out that Plan B does not cause an abortion. They rely on the technical definition that conception and pregnancy beginning at implantation, thus the term abortion does not apply.

However, among persons who do understand the process of fertilization and implantation, many consider that human life begins at fertilization, and believe that preventing implantation is equivalent to abortion.

Labeling must be made more complete and dispensing/prescribing personnel must be required to explain this matter as part of informed consent. Some clients may chose to take their chances now, rather than risk long term psychological uncertainty.

Similar requirements should apply to statements proposing off-label use of standard oral birth control pills.

John R Buysman PhD