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 : EC566
Submitter : Mrs. Annette Burgess Date & Time: 10/12/2005 06:10:46
Organization : Mrs. Annette Burgess
Category : Individual Consumer
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?
No.
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
No.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. There is a secondary danger of allowing this drug to go into an over-the-counter class. If this pill were allowed to become an over-the- counter medication, it could deny a woman the safety of conversing with her doctor the medical risks of taking it, deny the woman the privacy of deciding if she wanted to take the prescription or not, and might allow the woman's mate to buy the drug and coerce her to take it against her wishes, her health or that of her unborn child. To change this interpretation would not allow a woman to have a witness (i.e., the doctor who would writes the prescription) that she indeed did ask for this drug. Changing this drug's designation to Over-the-counter, would not give the woman the privacy to make her own choice in whether this drug was too dangerous to her health or not. To change the interpretation might bring legal consequences upon the FDA or the stores selling this drug if a wrongful death suit were initiated.
2
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
No. What would be legal consequences in a wrongful death suit to the FDA and the stores who carry this OTC medication? A subpopulation ruling would open a pandora's box to all kinds of hybrid requests that would tie up government as well as be a financial burden on stores which
carried such products as they'd have to hire additional employees, etc. in an already stressful environment to provide timely prescriptions. Talk about back-log!
B. If it could, would it be able to do so as practical matter and, if so, how?
It couldn't. This would open the door to all kinds of age-related or hybrid
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
No, because of the harmful side effects of this drug.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It should not be legal.
GENERAL
GENERAL
There is a secondary danger of allowing this drug to go into an over-the-counter class. If this pill were allowed to become an over-the-counter medication, it could deny a woman the safety of conversing with her doctor the medical risks of taking it, deny the woman the privacy of deciding if she wanted to take the prescription or not, and might allow the woman's mate to buy the drug and coerce her to take it against her wishes, her health or that of her unborn child. To change this interpretation would not allow a woman to have a witness (i.e., the doctor who would writes the prescription) that she indeed did ask for this drug. Changing this drug's designation to Over-the-counter, would not give the woman the privacy to make her own choice in whether this drug was too dangerous to her health or not. To change the interpretation might bring legal consequences upon the FDA or the stores selling this drug if a wrongful death suit were initiated.

No. What would be legal consequences in a wrongful death suit to the FDA and the stores who carry this OTC medication? A subpopulation ruling would open a pandora's box to all kinds of hybrid requests that would tie up government as well as be a financial burden on stores which carried such products as they'd have to hire additional employees, etc. in an already stressful environment to provide timely prescriptions. Talk about back-log!