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 : EC671
Submitter : Mrs. Mary Frances Friedl Date & Time: 10/12/2005 06:10:51
Organization : Mrs. Mary Frances Friedl
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?
no, the policy in effect now is adequate
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, the policy in effect now is adequate. A change in this policy could result in decreased safety for OTC drugs. It would shift policy definition from the scientific to the political arena.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
no
C. If so, would a rulemaking on this issue help dispet that confusion?
no
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?
No, the population under limitation would simply approach the population not under limitation in order to purchase the drug through a third party. The decision of whether or not to give the drug to the subpopulation would be made, not by physicians, but by individual OTC purchasers.
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?
Under all purposes.
GENERAL
GENERAL
This is one can of worms that the FDA should not be opening. Under the current circumstances, some drugs are OTC and some are not because it is presumed that proper use of prescription drugs requires specialized knowledge that is not available to the general public. Without this knowledge, the public cannot truly give individual and personal consent to the possible consequences of the use of the prescription drug. It these drugs are made OTC, the only source of information available to consumers will be via inadequate package information or through the recommendation of the pharmacist. Any change in the current policy is going to negatively impact both the safety of the public and the role of pharmacists.Patients will become mere consumers and pharmacists will become amateur physicians.