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 : EC702
Submitter : Mrs. Suzanne Doller Date & Time: 10/12/2005 06:10:19
Organization : Mrs. Suzanne Doller
Category : Health Professional
Issue Areas/Comments
1
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?
I am responding to your potential decision to allow the 'morning after pill' available as an OTC medication. The premise is that this drug, marketed as an 'emergency contraceptive' is also, in fact, an abortifcient, working after ovulation and conception by interfering with implantation of the embryo. Outside of the obvious moral ramifications of this, women will be aborting at home with the potential of dysfunctional uterine bleeding.Also, How can you control 'when ' women take this drug?( Right after intercourse? one week or one month after?) Even if you tell women it won't 'work' after a period of time, what will stop them from taking it at anytime? What will happen if there is an implanted baby at that time? Can you insure that there won't be a later term abortion or birth defects? This is too dangerous a medication to play with. As a CEN (Certified Emergency Room Nurse) there may be many issues complicating whether a woman should 'just take a pill'- social ,psychological and medical also. You will be opening a can of worms for women across the country- and Of course, this pill will only be more accessible for girls under 18, no matter what parameters you put on its sale.
Suzanne Doller RN CEN
Carlisle PA