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 : EC836
Submitter : Mrs. Mary Winfield-Kutza Date & Time: 10/13/2005 10:10:38
Organization : Friends
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?
Whatever action is necessary to get his product on the shelves for consumers to use as soon as possible, that is what needs to be done.
Stop fiddling while Rome is burning, I beg you.
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?
Whatever action is takes to get this product out, on the shelves, or otherwise, to the general public as soon as possible. If you care about human life, human safety, and truly want to help prevent unwanted, uncared for, unprotected babies being born into this world unnecesarily- get it out there on the shelves. Do whatever it takes.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
On this subject, if not others, the FDA is currently perceived right now as :
1) lying for political reasons
2) imbecilic non-decision
3) stalling for any reason they can make up
4) as necessary to this country as nothing
5) going against the votes of its own board
6) boondoggling of the highest order
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes!!!!!! Get that product on the shelves as fast as you can do it; no matter what the administration tells you to do. Everyone in this country, liberal and conservative perceives this as a politically directed action right now- do something good for a change & get rid of the black eye this will give the agcy forever. GET IT ON THE SHELVES, PRONTO!
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?
Forget the subpopulation. Forget the fine lines. Stop playing God. Get it on the shelves. Forget the prescription. Everyone sees the 'dilemma' as nothing more than a coverup for the administration control anyway. They want poor people to keep having unwanted children for the Armed Forces... common knowledge.
B. If it could, would it be able to do so as practical matter and, if so, how?
In this country, they can put everything on the shelves from stuff for freezing warts off yourself to 'male enhancement' ....don't tell me you can't figure out a way to just put it on the shelves. No one believes the FDA anyway. Just do it, and maybe there will be so much gratitude, that will change.
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?
Forget the prescription baloney. While you argue over how many angels can dance on the head of a pin, women are losing their minds, babies are being mistreated, abortions with clothes hangers are being attempted...HELP! Just do the right thing & get it on the shelves if you have one iota of compassion in yourself!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Forget the two products. If a teenager wanted it, her older aunt, sister, cousin, friend, whatever would get it...obviously, this is the physician's lobbyist pushing for prescriptions for this thing. More likely, even they don't care. They would like it on the shelves so they see less butchered attempts and less starving, uncared for babies. GET IT ON THE SHELVES!