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 :

EC6

Submitter :

Mr. Evan Goodman

Date & Time:

08/29/2005 12:08:34

Organization :

Mr. Evan Goodman

Category :

Individual Consumer

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?

If we assume that Plan B has not been shown to be safe without prescription for children under 17, then the new regulations should be considered. A drug that can be very helpful to women and is only denied based on ideaology instead of science should be made available by any truly scientific health organization.

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?

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?

I am not aware of confusion within the act; however, I do know that other drugs are over-the-counter and prescription when used in different ways. In doing that, it seems far less easy to regulate a drug that can be bought over the counter by anyone for the prescription use as long as they know what prescription drug it corresponds to. By allowing a drug to have an age restriction, if it is truly based on health issues, the drug can be regulated in much the same way as tobacco and alcohol.

C. If so, would a rulemaking on this issue help dispet that confusion?

If there is confusion on any issue, wouldn't making a rule to dispell the confusion take it away. I don't believe this question is even worth asking.

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?

Regulations based on age have existed in this country since it's onset. Voting was the first restriction, tobacco and alcohol have legal ages for purchase at stores across the country. In the same store as a pharmacy, often beer is sold and so are cigarettes. Both of those require the vendor to

check ID. Plan B could easily impliment this precaution, and if making a box say must check ID on it isn't enough, the barcode could make the register beep to check ID and have the cashier have to push a button if the ID has been checked.

B. If it could, would it be able to do so as practical matter and, if so, how?

Similar methods to alcohol and tobacco could easily be used to regulate the sale of drugs. The box could have obvious differences such as labelling and shape to make sure the cashier realizes that he has to check ID. Furthermore, as implemented for alcohol at some cash registers, the register itself could beep to check ID when the barcode is scanned, and the cashier would have to check the ID before pushing a button to ok the sale.

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?

I don't understand why it wouldn't be legal, but it may in fact, at present, not be. And, even if it is illegal, the pharmacy could hold different packaging for the same medicine in the back as the over-the-counter version. Again I point to tobacco and alcohol as examples of packaging restricted to younger age groups.

B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?

Prescription and non-prescription Plan B, assuming they are two products for legal purposes, are the same exact drug and do not need different warning labels or precautions. So, it would only be inappropriate to put them in the same package if all warnings were not on the single package and if it did not specify the age restriction for distinguishing purposes.

GENERAL

Abortion is legal in this country, so not selling Plan B, even if it is put in the category of an abortion drug, because abortion is morally wrong to some people would be poor judgment. This point is especially true considering separation of church and state in addition to the privacy issues brought up by Roe vs. Wade. Furthermore, the FDA is supposed to approve drugs that are found to be safe and effective. Aspirin, for example, is safe and effective, but only for people over a certain age. It is not safe for young people because it can cause Reye's syndrome, but is still marketed over the counter to all age groups. So, I put it to you, if you want to be hypocritical by limiting one drug that you claim might be dangerous to children and don't limit another known to be dangerous, say so, and give a good reason for it. I honestly think the FDA has made a big mistake in waiting this long, and if you are not in fact doing it for political, moral, or religious reasons, I would like a better explaination.