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 : EC1032
Submitter : Ms. Judy Ladd Date & Time: 10/27/2005 10:10:26
Organization : Ms. Judy Ladd
Category : Federal Government
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?
To use an ingredient in both OTC and by prescription only muddies the water as to who will receive what and in what form and intensity (dosage). It should be OTC only to assure that if someone wants it, it's available.
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 is unclear and opens a pandora's box of abuses by the pharmaceutical companies.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Completely.
C. If so, would a rulemaking on this issue help dispet that confusion?
It depends on whether the ruling was in favor of the population as a whole or was it to knuckle under to the pharmaceutical companies.
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?
It would be impossible to regulate something that is readily available to every other person OTC.
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?
One would incur higher costs to receive the same ingredient by prescription because they would need a doctor's visit to get the prescription. Why would anyone want to raise the price of getting something unless it was in some way 'improved' by the interference of a health official?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
If another more restrictive drug were included that had side effects that needed monitoring by a health official would be the only way that that would be feasible.
GENERAL
GENERAL
The FDA has shown itself to be a patsy for the drug companies rather than a protector of the American public. It's time they did the job they were formed to do.