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 :

EC4

Submitter :

Mr. Michael Bilz

Date & Time:

08/29/2005 12:08:16

Organization :

Mr. Michael Bilz

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?

Has it done so for Ibuprofen? It is sold both ways today.

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?

Has it done so for Ibuprofen? It is sold both ways today.

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

I don't know, is there?

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

I'm sure that it would - how long would it take to make a rule? Longer than it did when so many people were denied access to the Alzheimer's medication that sent so many people back into the darkness and so many families living with the torment of seeing a loved one suffer? There was a miss-step for the Agency, as it were.

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?

Do they have a vehicle for enforcing it now? If so, what is it? Is it effective?

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

If there were an age limitation - it would become the responsibility of the Pharmacy provider to determine age - like we do for tobacco and alcohol. Now how does a fifteen year old girl prove her age without a parent? I sell tobacco to people only with a proper I.D. and I challenge

everyone that looks younger than 27. Like Alcohol + Tobacco - why wouldn't underage persons solicit the help of someone of legal age to buy this for them? The controls you ask for here have historically had work-arounds since their inception.

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?

Why not? They both do the same thing and the manufacturer sells these very same products in slightly more socially-concious countries and would then raise the cost of the drug by creating alternate packaging for various applications - and the cost would be passed onto the end-user, not the drug company.

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

I can't think of a situation where it would be an issue.

GENERAL

Dear FDA,

I will start by saying that I respect your job and I feel the American consumer is safer, as a whole, for your agency's regulations on both food and drugs. I understand that it must be a difficult position to make these tough decisions regulating for people that cannot answer for themselves - and most of us are unaware of your role in our lives...as it should be.

In regards to the Plan B Emergency Contraception ruling I believe that it is today, it was yesterday and it will be tomorrow a WOMAN's right to choose what is best for her body. No MAN should be allowed to legislate one way or another over a WOMAN's reproductive rights. Plan B E.C. has a specific application and it's use should NOT be regulated by the 'moral' or 'religious' convictions of any individual. Plan B should be on the shelf next to all other contraception, accessible to all persons. Yes, I agree that underage girls should be challenged for proof of age at the register - but first we need to have stronger Health + Sex Education in our school systems from an early age to allow all persons to be able to make an educated decision on what is best for their Body AND Mind. We're not stupid, we're just under-educated. Start education early and have an informed public. Plan B is important for everyone - I'm tired of supporting unwanted pregnacies through social programs that show children as a dollar figure to a poor family. Reform the social welfare systems and EDUCATE the population - STARTING TODAY..!!

Thank you for listening.

Sincerely,

Michael L. Bilz