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 : EC416
Submitter : Dr. Donald Thompson Date & Time: 09/20/2005 04:09:46
Organization : National Defense University
Category : Health Professional
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. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a concern that oral contraceptives have been available by prescription only. It seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC.
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. The rulemaking should state that an active ingredient cannot be simultaneously marketed in both prescription and OTC product forms. Either the concerns about biologic safety and regulatory safety are sufficiently low that there is no need for a prescription, or the concerns are sufficiently great to keep it prescription only. Biologic safety issues for estrogens and progesterones have always been enough of a concern that oral contraceptives have been available by prescription only. It seems to be a dilution of regulatory policy and responsibility to permit any estrogen/progesterone product to be available OTC.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes. I do not understand FDA's interpretation of section 503(b) of the act. I applaud Commissioner Crawford's recognition that regulatory policy issues must consider more issues than simply the scientific safety concerns. Observations of human behavior strongly suggests that alterior motives often lead to misuse and abuse of prescription, OTC, and illegal drugs and other substances, such as Scheduled narcotics, alcohol, and tobacco products, leading to a great degree of pain and suffering. FDA must consider all these issues and issue rules that protect vulnerable populations to the greatest extent possible.
C. If so, would a rulemaking on this issue help dispet that confusion?
Yes. See above.
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?
No, neither FDA nor state and local authorities would be able to enforce such limitations. Law enforcement and regulatory activities are often low on the priority list for local officials compared to violent crime, so such legal enforcement is very unlikely to occur.
B. If it could, would it be able to do so as practical matter and, if so, how?
I don't see how such a limitation could be enforced. Our nation has a long history of minors getting access to many drugs and substances that are not legal, such as alcohol and tobacco, for which there is only a personal desire for gratification. Prevention of pregnancy with OTC emergency contraception opens the door to sexual predators who could easily purchase the medication OTC, then require their victims to use it. The scientific literature is clear on adolescent decision making processes and risk taking for short term gain. FDA regulatory guidelines must protect this vulnerable population.
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. If there is any rational reason for allowing an ingredient to be marketed both by prescription and OTC, the packages must be different, the labels must be different, the warnings must be different, and the limitations on access must be enforceable.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Anytime there are biologic or behavioral safely issues associated with access to the products, it would be inappropriate to sell such a product in the same package.
GENERAL
GENERAL
Prescription access to emergency contraception does not place an unreasonable burden on its availability. It protects vulnerable young women from sexual abuse and violence, to some degree, and requires all users to consider the possible outcomes of their actions. Healthy behaviors and healthy choices are to be strongly encouraged by our society and our governmental agencies, including responsible diets and exercise, reducing tobacco use, and moderating alcohol use. Increased access to emergency contraception is likely to increase the sexual abuse of vulnerable teenagers, and is unnecessary for responsible persons who are over 18 years of age.