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 : EC665
Submitter : Mrs. Annette Orendain Evans Date & Time: 10/12/2005 06:10:36
Organization : Our Lady of Hope Academy
Category : Academia
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?
Studies should include a "moral impact" from the product.
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?
Same comment as above.
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?
FDA is supposed to oversee and limit hazardous drugs/products.
B. If it could, would it be able to do so as practical matter and, if so, how?
The law should clearly indicate their duties.
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?
Is it legal to sell a drug that kills babies? This is just another form of abortion! By the way, if you check past history of the drug, it not only kills the embryo but many times the Mother too.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Is it lawful to kill? Read the Bill of Rights!

"See Attachment"

This product follows the same issues that Americans have struggled with since 1973 in Roe v. Wade. Embryos have rights too.

WE DON'T NEED ANYMORE DRUGS TO KILL BABIES AND MOTHERS. NOR DO WE NEED DRUGS THAT FURTHER IMMORALITY AND IRRESPOSIBILITY. WE NEED POSITIVE, UPLIFTING LAWS THAT HELP BUILD FAMILIES AND A RESPONSIBLE AMERICA - AN AMERICA WE SHOULD BE PROUD OF.
GENERAL
GENERAL
"See Attachment"

This product follows the same issues that Americans have struggled with since 1973 in Roe v. Wade. Embryos have rights too.

WE DON'T NEED ANYMORE DRUGS TO KILL BABIES AND MOTHERS. NOR DO WE NEED DRUGS THAT FURTHER IMMORALITY AND IRRESPOSIBILITY. WE NEED POSITIVE, UPLIFTING LAWS THAT HELP BUILD FAMILIES AND A RESPONSIBLE AMERICA - AN AMERICA WE SHOULD BE PROUD OF.