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 : EC61
Submitter : Mr. Alan Card Date & Time: 09/01/2005 04:09:39
Organization : U. of South FL Public Health Student Association
Category : Academia
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. No further rulemaking is required to allow for simultaneous Rx/OTC marketing, and the sudden question about the matter is doing a grave disservice to the FDA. It appears to be (and, frankly, let us all admit: it is) simply a delaying tactic being employed against the Plan B emergency contraceptive for purely political reasons. The reputation of the FDA as an unbiased arbiter, which bases its decisions solely on scientific has suffered a terrible blow as a result of this deeply misguided policy, and public trust in this institution is too important to be squandered.
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. No further rulemaking is required to allow for simultaneous Rx/OTC marketing, and the sudden question about the matter is doing a grave disservice to the FDA. It appears to be (and, frankly, let us all admit: it is) simply a delaying tactic being employed against the Plan B emergency contraceptive for purely political reasons. The reputation of the FDA as an unbiased arbiter, which bases its decisions solely on scientific has suffered a terrible blow as a result of this deeply misguided policy, and public trust in this institution is too important to be squandered.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No. If there were, it would have come up long before now. This supposed question is obviously nothing more than a politically motivated delaying tactic, a rearguard action of partisan politics vs science.
C. If so, would a rulemaking on this issue help dispet that confusion?
There is no significant confusion to be dispelled.
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?
Of course this plan would be enforceable under law, just as age restrictions on the purchase of tobacco and alcohol are enforceable under law. The legal powers of the FDA are more than broad enough to allow for this.
B. If it could, would it be able to do so as practical matter and, if so, how?
Absolutely. I would recommend the wholesale borrowing of state statutes regulating tobacco sales as the basis for regulation and enforcement.
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. There is nothing whatsoever to prevent it.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None, provided that the labeling requirements for the OTC product were the same as for the prescription product. We thereby ensure that the consumer is, under all circumstances, guaranteed the most complete data upon which to base his/her decisions with regard to the use of the product.
GENERAL
GENERAL
I am writing today primarily to express my deep revulsion for the politicization of the drug regulation process I have witnessed with regard to the Plan B emergency contraceptive. Neither the science (in the case of the first delay) nor the law (in the case of the present delay) provide any justification whatsoever for the absolutely singular treatment this drug has received. The only POSSIBLE reason for the continuous obstructions it has faced is that there are policy makers in the FDA who are basing their decisions not upon what is best for the health of the American public, but upon what is best for the political goals of the Republican Party. This subversion of an honored American institution cannot be allowed to continue. The confidence the American people have in the FDA is based on the belief that the agency will make the best decisions it can on the basis of the best scientific data available. It is based on the notion that they can rely upon the FDA to examine that data WITHOUT political, religious, personal or financial bias. It is a matter of trust... and that trust is being betrayed. I implore you, before you do any further damage to the FDA and to the long-term health of the American public (how effective will you be, if no one listens anymore?) to please, please, PLEASE return to making rational policy decisions without regard to politics. This should have been, as they say, a 'no brainer.' The drug is safe. It is effective. Its side effects are minimal; many other OTC drugs are more risky than this. Move on this application. Move on it today. And make the right choice to begin rebuilding confidence in the FDA. Thank you.