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 : EC833
Submitter : Mrs. Lori Hogg Date & Time: 10/13/2005 10:10:56
Organization : Mrs. Lori Hogg
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?
You do not have an outline of what section 503(b) is, however, I believe the FDA needs to eliminate confusion between prescription and OTC drugs. The FDA should NOT make Plan B available over-the-counter to anyone, especially on the criteria of age. We have examples of alcohol abuse both in bars and stores because it is impossible to determine age based on sophisticated fraudulent identification. It sends the wrong message that prescription drugs, that contain hormones and other ingredients with health risks be available OTC as if it were aspirin. Aspirin is something that we take without thinking, are we to allow women to take something like this to "take care of" overindulging...not apirin for a headache from drink, but hormonal drugs to counteract the possible consequence from overindulging sexually.
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?
I do not think a drug with active ingredients should be simultaneously marketed in both prescription drug and OTC. We have to ask the question why market? It is to market the product and make prosperous the pharm. company and related agencies supporting the marketing of this product. If it is like birth control pills, it has dangerous side affects. Why make this product available in more than one form of marketing channel. If it must hit the market (which I am apposed to), limit access to prescription only.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Forgive me for not further researching section 503(b), however, the FDA needs to do whatever is needed to further clarify that drugs cannot be marketed as prescription and OTC, especially when the use of the drug and outcome is the same. It is also impossbile to use age as a criteria. I am now 42 and at 17, it would have been an incredibly irresponsible choice to go out and buy a single packaged or multi-pack of the morning after pill simply to hide my irresponsible sexual actions. I already believe it was inappropriate that I was able to receive birth control pills at such a young age without the approval of my parents. The side affects are serious, some are probably not even discovered yet and/or disseminated. The FDA should protect the lives of the women ignorantly taking these pills as though it was aspirin, as well as unborn children. This is a move in the wrong direction for women's health and women's rights.
C. If so, would a rulemaking on this issue help dispet that confusion?
Again, do what is needed to make it clear that OTC and prescription drugs that have the same chemical reactions in a person's body, with the same outcome, are not to be sold through both ways. Due to the seriousness of the side affects, not to mention the whold ethical controversy, this drug
if totally allowed, should be through prescription only.
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. It will be impossible for the FDA to enforce making this drug available to the subpopulation, whether by age or other criteria. Similar to alcohol, it is impossible to properly "proof" people for age appropriateness. With identity theft and sophisticated means to make fraudulent identification, how can this be enforced? Parents and barowners can go to jail for serving underaged children, alcohol. I am sure this would expose pharmacists, doctors and stores to this risk. As a parent, I would certainly pursue these professionals and stores for selling this product to an underaged child.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. It could not. Pro-life, concerned parents, women that gain side effects from this drug and women that have "buyers remorse" for buying and taking such a drug, for such an ethical reason, will certainly pursue the inappropriate sale of this drug OTC. It is certain that there will be "plants" sent out to try to purchase the drug that are pretending to be 17 or older. Should we rely on drug store workers or even pharmacists to make the judgement call? Again, why make this so available? If people want to take it, then they should go through the proper education about the drug, its side effects and consequences of taking this drug.
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 know. It should not be legal to market the same active ingredient. If it does hit the OTC market, the packaging should be clear that this is no "candy" throat lozenge or aspirin, but a serious hormonal presription drug. People buy things today OTC without a lot of thought because it is thought that the FDA is looking out for the public and making less potent, less lethal, less dangerous drugs available. If we are saying that this is high enough risk to make prescription, as other birth control pills are, than, there is too a high a risk to allow it to be put on a shelf (even if behind a counter), without prescription, no matter what the packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
See comment above.
We are talking about a product that it will be impossible to monitor the purchase of such a drug. This drug, with higher doses of active ingredients than the birth control pill, will be made available for a young girl or woman to purchase as often as they would like as if it were a benign drug. This is wrong and goes against women's health. In years to come, as more women regret the choices they made, and as more become infertile, questions, lawsuits and investigations will be made and it is up to the FDA to protect us from the monney-making pharm. industry and related agencies that stand to profit from the misguided release of this drug.