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 : EC610
Submitter : Mrs. Frances Koch Date & Time: 10/12/2005 06:10:59
Organization : Mrs. Frances Koch
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?
I think that the FDA should make rules about when a drug can be sold as both prescription and OTC. The current usage - where the molecule/drug is used for different purposes/doses it is either prescription or OTC - seems intelligent enough. I think that actually codifying this would be good. Making sure that OTCs are safe enough to be used without the supervision of a physician must continue in the interests of public safety.Studies show that the American population routinely doubles, triples, even quadruples the recommended dosage on OTC medications - particularly pain medications. We have seen some medications go behind the shelf (pseudoephedrine) because of the misuse of the product. In this particular case of Plan B, it would be VERY easy for the product to be misused (18 year old buying it for a distraught 15 year old friend). People typically don't read instructions, they don't read warnings, they don't read about side affects. They just want to pop a pill and make it (pain, congestion, whatever) go away. How many people with high blood pressure will take Sudafed when the packaging says not to? At least with a prescription, the have the chance to speak with their physician. Their physician knows what they are taking, and knows their health history. Any medication that can cause severe reactions should be controlled. And I think that the studies for this should be conducted by someone other than the drug comapny and that the FDA should consider the results of ALL studies on a drug BEFORE it is approved for OTC status. Lighter doses of prescription medications as OTCs is helpful to the public and the pharmacies. But allowing a prescription to become an OTC must be done with careful, careful consideration, and with the EXPECTATION that the dosages available OTC will be at least doubled by the average consumer.
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?
This is the same as the box above - question and answer). I think that the FDA should make rules about when a drug can be sold as both prescription and OTC. The current usage - where the molecule/drug is used for different purposes/doses it is either prescription or OTC - seems intelligent enough. I think that actually codifying this would be good. Making sure that OTCs are safe enough to be used without the supervision of a physician must continue in the interests of public safety.Studies show that the American population routinely doubles, triples, even quadruples the recommended dosage on OTC medications - particularly pain medications. We have seen some medications go behind the shelf (pseudoephedrine) because of the misuse of the product. In this particular case of Plan B, it would be VERY easy for the product to be misused (18 year old buying it for a distraught 15 year old friend). People typically don't read instructions, they don't read warnings, they don't read about side affects. They just want to pop a pill and make it (pain, congestion, whatever) go away. How many people with high blood pressure will take Sudafed when the packaging says not to? At least with a prescription, the have the chance to speak with their physician. Their physician knows what they are taking, and knows their health history. Any medication that can cause severe reactions should be controlled. And I think that the studies for this should be conducted by someone other than the drug comapny and that the FDA should consider the results of ALL studies on a
drug BEFORE it is approved for OTC status. Lighter doses of prescription medications as OTCs is helpful to the public and the pharmacies. But allowing a prescription to become an OTC must be done with careful, careful consideration, and with the EXPECTATION that the dosages available OTC will be at least doubled by the average consumer.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I think that there is some confusion built into the act because it does not directly define when a product/drug/molecule is allowed to become an OTC. And when they are allowed to become both OTC and prescription at different usages or doses, there is still sp,e confusion about safety, use, etc. It gives the average consumer a false sense of security that no matter how much they take, a medication will not hurt them. The studies show that misuse and overmedication are rampant with OTCs. I also think that considering having the same exact medication as a prescription and as an OTC is a misinterpretation of the act.
C. If so, would a rulemaking on this issue help dispet that confusion?
I think that a more defined set of rules would help alleviate the confusion.
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?
I do not think that this would be possible. The accessibility of alcohol and cigarettes to minors - despite strict laws on the books - shows that in practice, limitations to subpopulations is not a practical solution. The ability to enforce the law would be basically non-existant, and therefore, the hoped for protections for any subpopulation that would come through requiring a prescription would not, for practical purposes, be in place.
B. If it could, would it be able to do so as practical matter and, if so, how?
It is ludicrous, insane, unresponsible to think that this would even be practical.
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?
NO. Again, that is totally irresponsible, insane, ludicrous. If you ever actually went down that path you'd have to have some way to determine the differenct in the general population, or you would NEVER be able to enforce the controls.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would NEVER be appropriate to do so. Under ALL circumstances it should be considered inappropriate to sell them in a single package.
GENERAL
GENERAL
This did not show up on the next page, so I am also attaching it as a Word file.

All women MUST have a prescription to get birth control pills. Why would you think that another form of birth control should be any different? This is also a pill that has had a lot of controversy over its safety. It should NEVER be put out as an OTC. There is no way of enforcing any laws that would keep an older person from giving it to a younger one that required a prescription. In addition, it essentially induces an abortion - of sorts. When you see a physician, they know your health history, they can tell you the benefits and the consequences. They can tell you of any potential problems to look for and when to come back or go to the hospital. The typical American does not even read the dosage information on a bottle of ibuprofen. If they hurt they take some, if they hurt a lot, they take a handful. Americans act like every OTC is safe - no matter how they take it or whom (age, weight, medical history, medicines being taken) they give it to. Putting any medication on the shelf and behind the shelf is a mistake because of the lack of practical and EFFECTIVE enforcement (think alcohol, cigarettes and teenagers). Putting a medication that could cause serious side effects on the shelf is an even worse choice. I encourage you to treat Plan B the same way you treat ALL OTHER birth control medications and leave it as a prescription for ALL ages. And I also encourage you to clarify section 503(b) of the act so that any OTC MUST be a "non-prescription" dose that can be taken at multiple times the recommended dose without harm or has an alternate presentation and use (ex. Benedryl pills or Benedryl in itch cream). And codify the act so that the same dosage of a medication cannot be BOTH prescription and OTC.
I encourage you to look at ALL of the studies about Plan B usage, the increase in STDs and abortions in populations where it is easily available, and at the potential for harm in the medication when you are trying to decide if it should be made OTC. And do NOT make your judgements based on what other countries are doing. Many other places thought they were going to get one type of behavior with easy access to Plan B, and they got another one entirely. And please remember that women are usually the losers in the STD game, and where abortion or easy fixes for uneducated sex are readily available, the STD rate goes up. You will not be doing the female population any favors by making Plan B an OTC medication.
If you release Plan B as an OTC, you will be doing the American public, particularly the young women of America, a great injustice.
Thank you for your time and consideration.
Signed,
A hopeful mother of 2 young girls.