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 : EC946
Submitter : Mrs. Barbara Presnell Date & Time: 10/27/2005 08:10:13
Organization : Mrs. Barbara Presnell
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?
Over the counter drugs for a very specific purpose can be just that, no need to confuse this issue. When needed in larger amounts or for long term, physician guidance and direction is more necessary. Not with a one time use drug such as the morning after/ plan B pill. There is no conflict unless one does not want to apporove the drug in the first place.
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?
There should already be a rule for this event, don't make any more rules, use the ones you have. Not everything is special circumstance unless you are morally conflicted. Then, one tires to make up reasons to not act per exhisting policy.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Not for me. I see an agency that is well educated and has strong influence over public safety. They are not supposed to be goverened by the White House or other special interest groups. If they are, then they will not be effective. Remember what the FDA's role is. Not morality or religion or judgemental decisions. There was no conflict when Viagra was put on the market. Maybe I don't think everyone that wants to be able to have sex should have it, so maybe I don't what that drug on the market for moral reasons. Does that sound appropriate for medical and chemestry professionals to say?
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?
No way, unless you want to put sell the product like tobacco or alcohol. Then, other agencies would have to take over the police role. How about ATF/plan B as an agency? Sounds like someone is thinking too much for others.
B. If it could, would it be able to do so as practical matter and, if so, how?
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?
Doesn't sound illegal but it could be confusing to consumers and even drug store employees. Proper steps have to be taken, as in all packaging. I buy other things in different packages that are the same think all the time. Food items are always packaged per manufacture choice, these drugs would be packaged clearly too, per already in place rules and guidelines. They don't want confusion any more that the FDA does.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Perhaps for long term use.
Keep the White House out of the FDA's bed. When the goverment decides what is available and what is not, we are no longer democracy, we are now a dictatorship. Give the public some credit to use over the counter drugs for a positive purpose and if they don't, let the public complain for a change. Stop trying to decide for the world what is right. Just decide what is medically safe and step back. You can die from asprin, no one is trying to stop that from being over the counter. You can misuse mouthwash, rubbing alcohol and cold medications too. As a substance abuse counselor, I have learned that folks make choices. As a nation, we do our best to keep people safe and if people decide to make poor choices, then they are the ones living with those consequences. It looks like only some at the FDA are condused. I am not. Thank you.