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 : EC580
Submitter : Mr. Dana Farmer Date & Time: 10/12/2005 06:10:38
Organization : Mr. Dana Farmer
Category : Health Professional
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?
This drug should not be marketed in any circumstance. Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone.
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?
This drug should not be marketed in any circumstance. Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
This drug should not be marketed in any circumstance. Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone.
C. If so, would a rulemaking on this issue help dispet that confusion?
This drug SHOULD NOT be marketed in any circumstance. Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone.
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?
This drug SHOULD NOT be marketed in any circumstance. Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone.
B. If it could, would it be able to do so as practical matter and, if so, how?
This drug SHOULD NOT be marketed in any circumstance. Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone.
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?
THIS DRUG SHOULD NOT BE MARKETED IN ANY CIRCUMSTANCE! Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone!
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
THIS DRUG SHOULD NOT BE MARKETED IN ANY CIRCUMSTANCE! Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone!
GENERAL
GENERAL
THIS DRUG SHOULD NOT BE MARKETED IN ANY CIRCUMSTANCE! Health Care workers I know are extremely concerned with the effects and dangers of Mefepristone! Is the opinion expressed made any clearer now? I'm a nurse and I work with nurses daily! WE ARE ALL CONCERNED WITH THE SAFETY OF ANYONE USING THIS DRUG!!! We would rather our daughters tell us before using this drug and all the nurses I work with say that their daughters would be perfectly safe if they wanted to tell us that they were considering use of this drug! IT'S DANGEROUS AND WE VALUE OUR CHILDRENS LIVES MUCH MORE THEN DRUG COMPANIES WHO VALUE ONLY PROFITS!!! Thank you for the opportunity to comment.