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 : EC283
Submitter : Dr. Wayne Richey Date & Time: 09/20/2005 03:09:12
Organization : Redmond Family Care
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?
No. The Agency is charged with determining whether a drug can safely be used without physician supervision by the general public without undue risk of significant health consequences, physical or emotional impact, or life-threatening events even if the exposure exceeds recommended limits or is accidental in nature. As a practicing family physician, my judgement is that the answer to such a question is either yes or no, and my patients' individual lives depend upon that decision. Any other answer is unenforceable and unconscienable.
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?
No. The Agency is charged with determining whether a drug can safely be used without physician supervision by the general public without undue risk of significant health consequences, physical or emotional impact, or life-threatening events even if the exposure exceeds recommended limits or is accidental in nature. As a practicing family physician, my judgement is that the answer to such a question is either yes or no, and my patients' individual lives depend upon that decision. Any other answer is unenforceable and unconscienable.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. The Agency has exercised great restraint in taking any action that would cloud its policy. The safety of any individual drug is an issue which demands undeniable clarity.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. The policy and precedent are clear.
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. By requiring prescription for a subpopulation, the Agency would tacitly admit that the product has significant potential to cause devastating harm in misuse. Much as tobacco still finds its way into the hands of and causes demonstrable harm to the bodies and health of minors despite
significant enforcement efforts, the Agency would become ultimately liable for both accidental and intentional circumvention of the subpopulation limits.
B. If it could, would it be able to do so as practical matter and, if so, how?
No. The Agency would presume upon the good intentions of those who both control and request access to the drug in question, a certain number of whom will act to circumvent the regulation out of selfish or deviant motivation without due deliberate regard for the safety of those individuals in the restricted subpopulation whom they will expose to the restricted drug for personal gain. The continued use of tobacco products by minors despite significant enforcement effort is ample evidence that such enforcement has failed in a real-life setting. The Agency would also dismiss to its detriment the burden of responsibility it now shares with physicians duly trained and duty-bound to protect individual safety in the daily use of prescription drugs.
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. The Agency invites confusion for both consumer and enforcement agents, compromising the very safety issue which is the heart of the Agency's mandate and the current question.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
Any circumstance in which accidental exposure to the drug in question has the potential to cause significant harm to the individual exposed.
GENERAL
GENERAL
As a practicing family physician, it is my fervent hope that the Agency will defend its role as an impartial advocate of consumer safety with regard to medical drugs. I urge each member to resist the political and social agenda that would liberalize exposure to potentially devastating drugs for financial gain without regard to the effect on human lives. The specific drug in question has no legitimate use without the dispassionate advice and supervision of a concerned physician trained to guide patients through sensitive issues regarding their sexual health and safety. Such supervison is appropriately required of lower doses of the same drug in oral contraceptive pills, and the Agency would be remiss if it did not recognize the devastating consequences of an unwise decision in this matter.