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 : EC747
Submitter : Ms. Sandra Jordan Date & Time: 10/13/2005 08:10:04
Organization : Ms. Sandra Jordan
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?
I do not think that initiating rulemaking is necessary - the confusion has arisen because FDA have allowed science to be tainted by politics. Individuals are "confused" only because they are blindly following one ideology designed to enforce morality. FDA have already determined the health validity of emergency contraception and determined it was safe. What rule is necessary?
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?
I repeat my comment above. This would not be necessary if FDA had not allowed this to become a political issue.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
There is not significant confusion; there is, however, significant politicking around this issue. There is a faction in this country that would impose its notions of morality on the nation as a whole and FDA has fallen into this political argument.
C. If so, would a rulemaking on this issue help dispet that confusion?
I doubt seriously a rule would change anyone's mind who believes EC should be made freely available nor would it change the mind of someone who does not believe in EC. I don't believe in viagra - why wasn't it put forward to the American people before being made public. This whole exercise only speaks to the lack of confidence thinking people now have in the FDA to make clear scientific decisions.
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?
Doubtless FDA can do whatever it chooses to with the backing of an Administration that feels the constitution or rule of law is a negligible matter when fulfilling the demands of a powerful minority.
B. If it could, would it be able to do so as practical matter and, if so, how?
Why would you restrict this to a sub population, ie youngsters under 16. At what point in time was FDA decreed to be the guardian of virginity? At what point in time did FDA do scientific studies that show availability of EC, or oral contraceptives or condoms for that matter, increase sexual activity? At what point was FDA given the right to decree that the agency had the right to determine the appropriate age for sexual activity?
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?
If it is the same active ingredient, then it is the same product. So, yes, they can be sold legally in the same package because they are the same thng.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If the product has been determined to be safe and effective, there would be no inappropriate circumstances. Warnings could be placed on the package suggesting that use might cause a person to engage in sexual activity. Woops, seems if they are seeking the product, the sexual activity may have already taken place. So guarding morals won't work there, just more teen brides will result. Perhaps what you're seeking here is a warning that pregnant women who choose to be pregnant probably wouldn't be wise to take the product.
I am outraged at the politicization of the FDA, if you have not figured this out already. Cease and desist and go back to doing the work you were formed to do and leave politics to the politicians. Shame.