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 : EC623
Submitter : Mr. Conrad DeWitte Date & Time: 10/12/2005 06:10:19
Organization : Concerned Parents and Citizens of Fullerton
Category : Consumer Group
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?
Yes. It would inform the voting and pharmaceutical consuming public to understand how such decisions are analyzed and made, including the medical purpose for creating at once a controlled and an uncontrolled distribution channel for the same product.
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?
Yes. As stated above, it would inform the voting and pharmaceutical consuming public to understand how such decisions are analyzed and made, including the medical purpose for creating at once a controlled and an uncontrolled distribution channel for the same product.

B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. For the layman and even for the well-informed layman, there appears to be a non-sensical aspect to this aspect of FDA regulations.

C. If so, would a rulemaking on this issue help dispet that confusion?
Potentially, yes. The rule making language should be developed so as to inform the public and thus strengthen understanding and public support for FDA decisions.

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?
This would seem to be "possible" to make this distinction and a common analogy would be the ability to enforce laws regarding the sale of alcoholic beverages to adults but make those same products illegal for sale to minors. But aside from the appearance of this possibility, the record of thousands or millions of violations of laws prohibiting the sale of liquor to minors suggests that in fact such limitations would be ineffecitve
except as "political cover" for craven and unethical governmental administrators.

B. If it could, would it be able to do so as practical matter and, if so, how?
As outlined above, this would seem to be "possible" to make this distinction and a common analogy would be the ability to enforce laws regarding the sale of alcoholic beverages to adults but make those same products illegal for sale to minors. But aside from the appearance of this possibility, the record of thousands or millions of violations of laws prohibiting the sale of liquor to minors suggests that in fact such limitations would be ineffecitve except as "political cover" for craven and unethical governmental administrators.

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?
If the FDA would seek to undermine public confidence in its purpose and effectiveness then such a plan should be pursued.

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 sell a highly dangerous drug as an Over The Counter formulation and such would be the case with the "morning after abortion pill." The FDA's interest in product packaging has been historically to ensure or at least further the goal of safety (i.e. tamper resistance, or cleanliness protection, or warning labling, or reduction of light exposure), but this question seems entirely designed to accommodate a product marketing consideration which suggests a cavalier attitude of FDA administrators with respect to the health safety of American consumers. Consideration of these aspects of this issue argue for aggressive scrutiny and change in the senior administrative personnel at FDA.

GENERAL
GENERAL
FDA would abandon its purpose and thus its right to exist (and thereby also its claim for public support) by approving a drug as an OTC product which has the power and purpose of terminating an existing human life (e.g. this is NOT preventative, but would in fact only be used if in fact the existence of pregnancy was known for certain to exist). The formerly, Pure Food and Drug Administration was created entirely to protect intended or potential users of pharmaceutical products. Only pharmaceutical products with the potential for minimal health hazard should be offered as Over The Counter formulations. In this instance the proposed product poses severe health risks including potential death for the consumer and near certain death for the intended target of the drug. It is by definition lethal or at least potentially lethal. There is zero justification for approving the availability of such a product in the least or essentially completely uncontrolled commercial envronment. It is well known that communities supported by families all over the nation enforce heavy guard over the potential of even common and well understood pharmceuticals which may be administered or otherwise made available to children or minors. Aspirin is absolutely unavailable to a child under twenty-one years of age in all of our public schools without specific control and approval. The FDA discards its authority to command any respect for its pronouncements if this powerful and absolutely dangerous drug is approved for uncontrolled distribution (i.e. as an OTC drug) in the face of an entire nation's effort to make pharmaceuticals available only in the most carefully controlled and well advised setting. There is no medical reason, no practical reason and no ethical justification for approval of this proposal to make an abortion drug available Over The Counter.

Conrad J. DeWitte
Fullerton, CA