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 : EC955
Submitter : Dr. Kyle Beiter Date & Time: 10/27/2005 08:10:54
Organization : Dr. Kyle Beiter
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
To whom it may concern,

I am emphatically against making 'Plan B' available as an 'over-the-counter' drug.

According to the Manufacturer's PDR insert:

'Plan B is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium).'

Thus, Plan B does indeed act as an abortifacient at times, by preventing the implantation of an embryo into the endometrium. Although various organizations have shifted the definition of pregnancy as starting only at implantation, many (if not most) women conceptualize pregnancy in the traditional formulation as beginning with conception and the formation of an embryo. Most women would take the statement 'Plan B is not effective in terminating an existing pregnancy' to mean that Plan B does not terminate a pregnancy at any stage from conception onwards.

Women are generally not aware of this possibility, and presumably many would like to know of the abortifacient potential of Plan B before taking it themselves.

Some states also have laws regarding parental consent for elective abortions. Providing 'Plan B' over the counter precludes parental consent.

I have attached an article, 'Postfertilization Effect of Hormonal Emergency Contraception' by Kahlenborn et al. in the Annals of Pharmacotherapy (Ann Pharmacother 2002;36:465-70.) which summarizes the scientific literature regarding emergency contraception as abortifacient.

Sincerely,

Kyle Beiter, MD
Obstetrics and Gynecology Resident
New York, NY
2005N-0345-EC955-Attach-1.PDF