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 : EC1041
Submitter : Mr. Thomas Speight Date & Time: 10/27/2005 10:10:48
Organization : Mr. Thomas Speight
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?
The FDA should clarify all regulations so that they can be understood by the layman, and possibilties for abuse may be minimized.
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?
To the extent that the same ingredient may be present in different combinations and different proportions in prescription and OTC medications, yes the FDA should evaluate existing regulations to ensure that the public good is protected.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, if the FDA has finally gotten around to realizing that it needs to be rulemaking.
C. If so, would a rulemaking on this issue help dispet that confusion?
If such a rulemaking would not in any way change the intent or action of the section's language, yes.
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 does not appear possible or cost-effective for the FDA to attempt to enforce such a law, nor would it be in the interests of the public good to do so. There is, simply put, no good legal reason in current federal case law or constitutional law to restrict the OTC sale of contraceptive products (broadly defined), allergy medication, antibiotics, or other products in such a manner. Doing so would intrude heavily onto the issue of doctor- patient privilege and would also bring up the question of the right to privacy as determined in Griswold V. Connecticut.
B. If it could, would it be able to do so as practical matter and, if so, how?
Restricting such a product's availability would probably require new case law or revisitation of existing precedents to determine the legality of restricting such products, as well as the FDA's authority to do so. Given the current erosion of support for broad interpretation of the Commerce Clause, it appears unlikely that the FDA would be able to do so in the current legal environment. Such a move would also likely be very unpopular with the population as a whole.
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?
As the same ingredient may be present in different combinations and very different proportions in prescription and OTC medications, it would be extremely unwise to allow identical packaging. Use of the wrong product due to mistaken identity, or the assumption that the products are the same, could lead to adverse reactions, injury, or death.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
see 3A
GENERAL
GENERAL
As a general comment, I would like to remark that the current environment of medical costs increasing well ahead of the rate of inflation and the prevailing average wages is not sustainable for the long term, and that both drug companies and medical providers will have to drastically restructure their arrangements if the current economic decline continues.