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 : EC2053
Submitter : Dr. Christina Hull Date & Time: 10/31/2005 05:10:45
Organization : Dr. Christina Hull
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?
Absolutely not. Rulemaking in this case is completely unnecessary and not supported by existing data.
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?
Absolutely not. Rulemaking in this case is completely unnecessary and not supported by existing data.
C. If so, would a rulemaking on this issue help dispet that confusion?
Absolutely not.
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?
Yes.
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?
Yes.
GENERAL
GENERAL
All internal FDA reviews have indicated that approval for OTC use should be granted. It is clear that a rulemaking process is not necessary. Approval is in the best interest of public health, and this makes the delays caused by the rulemaking unncessary and irresponsible. Agencies like the FDA should not ignore data and be ruled by politics or special interest groups. The proposed additional delays in approving Plan B for OTC use indicate a lack of respect for the scientific process and undermine respect for the careful, impartial reviews traditionally conducted by the FDA. Please take appropriate steps to maintain the health of Americans and approve Plan B for OTC use as soon as possible. The current process threatens to undermine confidence in the FDA, and nothing could be worse for the health of Americans.