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 : EC1842
Submitter : Mr. Aaron Method Date & Time: 10/31/2005 03:10:10
Organization : Mr. Aaron Method
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?
In this case the main reason the product will not be marketed to those under 16 has to do with laws regarding sexual activity, not because of science. Perhaps a codification that states that age-of-consent rules acknowledged by society can influence the OTC availability of a contraceptive like this on a case-by-case basis, would be appropriate. There are other precedents for age-based restriction of access on a statewide basis, such as alcohal, tobacco and stimulants.
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?
In this case the main reason the product will not be marketed to those under 16 has to do with laws regarding sexual activity, not because of science. Perhaps a codification that states that age-of-consent rules acknowledged by society can influence the OTC availability of a contraceptive like this on a case-by-case basis, would be appropriate. There are other precedents for age-based restriction of access on a statewide basis, such as alcohal, tobacco and stimulants.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
The confusion lies outside the ability of the FDA to regulate. It is a fact that the age of menses is dropping. It is a fact that this is allowing younger and younger girls to become pregnant. It is a fact that this is happening. It is a fact that society does not want to deal with this issue. That there is "confusion" about this is an indication that this disconnect between society and biology is causing a rift that goes far beyond your regulatory mandate.
C. If so, would a rulemaking on this issue help dispet that confusion?
The only rulemaking that could possibly help would be one that would indicate that OTC access to EMERGENCY contraceptives be restricted to individuals over the age of 16.
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?
It would be enforceable, in conjuction with other regulatory and law-enforcement agencies.
B. If it could, would it be able to do so as practical matter and, if so, how?
Tobacco, alcohal and stimulants are all sold OTC on an age-restricted basis. In many areas cold medicine is sold OTC on a quantity-restricted basis. Requiring that the packages be held behind a counter with a signature sheet, for example, works with various additives and drugs on a state or county level. You have to show a picture ID with a birthdate on it and sign the book to recieve the drug. However, this book should be treated as confidential medical information subject to HIPPA rules.
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?
Certainly, if one follows the above guidelines. The package is the same, the only requirement is that someone without a photo ID must give have a prescription.
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 be inappropriate to do so where formulations are different. If there is an OTC version that is weaker than the prescription version of the same drug, then there is different packaging. If it is one of those sticky capsules that adheres to the back of the throat easily instead of an easy- swallow pill, then it needs to be indicated as such. And of course drugs that have different active ingredients or made by different manufacturers need to be packaged differently.
GENERAL
GENERAL
This whole issue revolves not around science but around morality and changing human biology. As the age of menses drops, so does the age where girls start getting pregnant. And unfortunately the way we treat this issue is to pretend that it is her fault when the rules are in place to prohibit such behavior because someone of that age cannot make an informed decision. While I would love to see this go completely OTC specifically to deal with the young women who can't afford the doctor visit on an allowance and may be horribly abused physically or emotionally or both at home for making a mistake, I also know that society right now can't stomach the idea. A girl's body does not belong to her, it belongs to her parents, and we simply aren't ready to reconcile changing biologies with what is considered proper conduct.

However, to prevent women from having access to a safe, effective drug because of this age-and-gender related issue would simply be irresponsible. The FDA should not deviate from its mandate of approving drugs based on scientific evidence. It should not be hurried because of popular pressure (as was shown in the thalidomide case) but it should also not hinder the release of safe drugs because of nonscientific concerns.

The FDA has rarely been put in this spot; of course you are used to preventing popular but unsafe drugs from getting to market. That is your job. However, that safety has not been questioned here or abroad. To regulate this based on morality outside of safety for the patient would simply undermine the authority and credibility of the FDA. I have nothing but respect for the way that the FDA has carried out its mission, despite tremendous pressure, in the past. Remember that you are here to promote medical science and health, and that is how this case, like all others, must be evaluated. There are complex negotiations necessary to allow this to happen, and that is why I urge the age-based prescription option be allowed. If this is found to be unworkable, simply prohibit its sale to those under the age of 16, period, and make it available OTC to all others.