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 : EC647
Submitter : Mrs. Rosie Bosse Date & Time: 10/12/2005 06:10:04
Organization : Mother, wife, and someone who miscarried a child
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?
There is no way this should be marketed to teenagers. I have had a miscarriage and it is very disturbing. How dare you market a product that induces this. You want our daughters to be able to purchase this product with no questions asked when they cannot even take aspirin in school without permission! I think it is dispicable what the medical profession is doing to women and calling it progress. I am abloslutely against this drug all together, let alone without prescription. Bring on the lawsuits when it is taken wrong and a deformed child is born as a reslult of this drug. Rosie Bosse
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?
Is this your biggest concern? What about the safety of those taking it? How do you feel about gun control? You have to be 18 to buy bullets!! But a 16 year old is considered "adult" when it comes to killing an innocent child who can't speak out for itself! Shame on all of you. How gutless are you anyway? Rosie Bosse Onaga, KS
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The only confusion here is the lack of care as to whether this should be taken at all. What person is going to read any of the fine print let alone read the directions? Especially one who is upset! How about illiterate? Or are you targeting the poor and uneducated on purpose? I can tell you that as someone in sales that it is a rare individual who reads the information that comes with any product. Rosie Bosse, Onaga, KS
C. If so, would a rulemaking on this issue help dispet that confusion?
I have a suggestion--don't make it legal at all!! Sometimes, your dept. looks for problems and this one is shouting at you! Make it illegal because you know it is not safe. Miscarriage is much harder on a woman that normal child birth. Rosie Bosse Onaga, KS
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?
Again, don't make it legal. You obviously see there are going to be problems. Rosie Bosse Onaga, KS
B. If it could, would it be able to do so as practical matter and, if so, how?
Hello? Hello?? Health of the woman?? Life of the child?? How many more do you want to die in a pool of blood in a car?
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
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Evil is always evil no matter how it is packaged.
GENERAL
GENERAL
I can't believe that this is what your biggest concern is. Did you read no information on the problems that this will create? How can you even consider legalizing this? Just once, have some guts and say, "NO!" Rosie Bosse