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 : EC1954
Submitter : Mrs. Diane Steele Date & Time: 10/31/2005 04:10:28
Organization : Mrs. Diane Steele
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?
Yes! A perfect example of this is the plan B emergency contraceptive for women. If all of the proper warnings about how this drug will affect smokers, and others possibly affected, this could forseeably reduce the number of inintended pregnancies and abortions. Please keep our young women healthy - prevention is the key. Thank you
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?
Yes!
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
It depends upon who you ask. If people are educated, they will see that prevention of unintended pregnancies is the key to eliminating abortion. There are already many types of medications that are sold both OTC and with prescriptions in the same packages.
C. If so, would a rulemaking on this issue help dispet that confusion?
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?
Yes. As an example, anybody who has a criminal background involving the use or manufacture of methamphetamine would have to acquire a prescription to get drugs such as Sudafed, which are commonly used to make meth. Also, persons under the age of 18 should have to get these drugs with a prescription.
B. If it could, would it be able to do so as practical matter and, if so, how?
Any way to slow the manufacture and use of methamphetamine is practical. The FDA is in a position to control the amount of ingredients for meth in the general public. Controlling the amount purchased at one time and the strength of the drug fall under the realm of prescriptions, so let's go for it!
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, the only difference needs to be the label used by the pharmacist when the drug needs to be prescribed.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
There needs to be all of the warnings and the usage information sheets included.
GENERAL
GENERAL
contraceptives and cold medicines are only two of the drugs which could be sold both by prescription and over the counter. Right now, there are megavitamins, anti-gas, metamucil, and many other drugs sold in both ways in the same packages (with the exception of the pharmacist's label). This can be expanded with little confusion.