|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 :||EC645|
|Submitter :||Mr. Robert Fricke||Date & Time:||10/12/2005 06:10:36|
|Organization :||Mr. Robert Fricke|
|Category :||Individual Consumer|
| 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?|
| 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?|
|B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?|
|C. If so, would a rulemaking on this issue help dispet that confusion?|
| 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?|
|B. If it could, would it be able to do so as practical matter and, if so, how?|
|Impractical. The 'subpopulation' will only serve as the first purchasers who will then widely distribute these drugs at large.|
| 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?|
|B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?|
|It would be inappropriate and dangerous without a prescription.|
| The reason that a prescription is now required, is to ensure that a physician examines the patient first-in order to determine the suitablitity of a drug regimen, and to evaluate the risks involved to the idividual. Patients are not competent to assess these matters themselves.
Establishing a precedent for OTC sales of this kind is certain to result in tragedy.
I have read the FDA Mission Statement, and conclude that the proposed changes are not consistent with your stated primary responsibility.