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 : EC827
Submitter : Mr. James O'Hagan Date & Time: 10/13/2005 10:10:31
Organization : Mr. James O'Hagan
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?
Yes it should. FDA rules are much more readily available as meaningful information to typical consumers.
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?
Yes it should. FDA rules are much more readily available as meaningful information to typical consumers.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Information regarding this interpretation is not well understood by the general public today.
C. If so, would a rulemaking on this issue help dispet that confusion?
A rule making on thi sissue helps significantly because of the clear, concise language which typically accomponies such rulemaking on the FDA site. While other information is also available on the site, a rulemaking is a more formal, dated document which is often used as a starting point by other stakeholders in creating their own communications.
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?
I am not qualified to answer that question, but I do know, firsthand, that there is already active lawbreaking and misrepresentation going on in society with respect to this medicine and that removing it from prescription for even a small subset of the population will have the practical impact of removing it from prescription for everyone.
B. If it could, would it be able to do so as practical matter and, if so, how?
Clearly not. Look at methamphetamines and alcohol as examples!
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?
It would be far preferable to have different National drug codes: then pharmacies could program POS systems and pharmacy automation systems to help police the use.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Why do you want to encourage someone with a prescription, likely subsidized by an insurance plan, to begin sharing their medicine with someone else? If it is legal for this drug, how will you communicate that it is illegal for other drugs?