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 : EC569
Submitter : Miss. Kathleen Tansley Date & Time: 10/12/2005 06:10:25
Organization : Miss. Kathleen Tansley
Category : Health Professional
Issue Areas/Comments
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?
I feel strongly that the FDA should not initiate a rulemaking to codify their interpretation of section 503(b), about duel-marketing both a prescription drug product and simultaneously an OTC product.

Making Plan B over the counter would create numerous problems especially with regard to keeping it out of the hands of minors. The FDA has no mechanism for enforcing a regulation that prohibits sale to minors. And enforcing this could not only cause serious controversy on both sides of the spectrum, but be very difficult to regulate.

I feel the FDA should step back and realize this, and not go further with this type of policy change.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I myself, am not confused by 503(b) as explained on your web site here. But I have written my serious concerns above (see A), and see no logical reason for the FDA to change their policy on this issue, it would create serious controversay, difficulty, and perhaps even future lawsuits from consumers at the extreme.

C. If so, would a rulemaking on this issue help dispet that confusion?
I believe the rulemaking should stay as it is. And not go change policy, allowing duel-marketing of both a prescription drug product and simultaneously an OTC product. The FDA should remain firm on this issue in this regard.
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?
Selective limitation of a product to a sub-population could bring on lawsuits from either end of the spectrum from disgruntled consumers, as well as media controversy on the issue, and a near insurmountable impossibilty to enforce such a regulation.

This is a bad idea for the FDA to pursue.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. I cannot see this happening.
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?
This again would be a cause for concern for the consumers, and controversy could arise, and laws must be changed, and I feel this
is incorrect to do a 'blanket change of policy for reinforcement on duel-marketing drugs' in this manner.

What if other drugs arise in the future and likewise the drug companies suppling the consumers would want the same option, and what if there is cause for concern that this would be detrimental to the consumers by doing this? The FDA would then have to do 'damage control' and back-pedal on their policy on rulemaking if they follow this route.