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 : EC828
Submitter : Mr. LLoyd Fojas Date & Time: 10/13/2005 10:10:47
Organization : Mr. LLoyd Fojas
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?
No, it would be of best interest for future issues that double standards not be formed in the FDA system ever. The facts from both sides, whether for or against the issue (at the practical and moral level) are getting media spins. FDA has to have the spine to dictate a prudent and just bill. Definitions cannot be askewed whether: life/death, tissue/human, healthy/safety, moral/political, enterprising/service, and right/wrong. Step back and look at the big picture perspective, are the expressed views a reality subject to micro-demographic relativity? Should this situation be associated with the rest of the population... or be regulated at that particular level? If the issue is only at that particular situation(s), rather then, should there not be a focused effort to seek a vernacular resolve in preventing the situation. Further more, rather thatn age categories, socio- economic status, or political standings, it would be advisable to resolve the issue of "unwanted-pregnancies" at the micro-cultural level, because after all the human condition is greater cause that the FDA is meant to serve.
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?
No, it would be of best interest for future issues that double standards not be formed in the FDA system ever. The facts from both sides, whether for or against the issue (at the practical and moral level) are getting media spins. FDA has to have the spine to dictate a prudent and just bill. Definitions cannot be askewed whether: life/death, tissue/human, healthy/safety, moral/political, enterprising/service, and right/wrong. Step back and look at the big picture perspective, are the expressed views a reality subject to micro-demographic relativity? Should this situation be associated with the rest of the population... or be regulated at that particular level? If the issue is only at that particular situation(s), rather then, should there not be a focused effort to seek a vernacular resolve in preventing the situation. Further more, rather thatn age categories, socio- economic status, or political standings, it would be advisable to resolve the issue of "unwanted-pregnancies" at the micro-cultural level, because after all the human condition is greater cause that the FDA is meant to serve.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, I feel it is dodging the issue
C. If so, would a rulemaking on this issue help dispet that confusion?
yes
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?
Not likely,just like gun restriction, the wrong poeple can get there hands on the product to abuse them.
B. If it could, would it be able to do so as practical matter and, if so, how?
Make sure the woman buying it ingest it on the site.
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?
none
GENERAL
GENERAL
No, it would be of best interest for future issues that double standards not be formed in the FDA system ever. The facts from both sides, whether for or against the issue (at the practical and moral level) are getting media spins. FDA has to have the spine to dictate a prudent and just bill. Definitions cannot be askewed whether: life/death, tissue/human, healthy/safety, moral/political, enterprising/service, and right/wrong. Step back and look at the big picture perspective, are the expressed views a reality subject to micro-demographic relativity? Should this situation be associated with the rest of the population... or be regulated at that particular level? If the issue is only at that particular situation(s), rather then, should there not be a focused effort to seek a vernacular resolve in preventing the situation. Further more, rather thatn age categories, socio- economic status, or political standings, it would be advisable to resolve the issue of "unwanted-pregnancies" at the micro-cultural level, because after all the human condition is greater cause that the FDA is meant to serve.