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 : EC1930
Submitter : Ms. Alison Bernstein Date & Time: 10/31/2005 04:10:56
Organization : Washington University in St. Louis
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. This decision to initiate a rulemaking is highly unusual for the drug approval process in the FDA. The commissioner overruled the decision of every level of management below him. This break from normal protocol is not based on any scientific or clinical data. All the clinical and scientific data supported approval, even without a two-tier system.
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. There are already many drugs that are marketed in a two-tier system. Some are sold in different doses OTC and by prescription or are indicated for different illnesses. There is no need for a rulemaking to determine if an active ingredient can be marketed as both a prescription drug and OTC. Just because this time it is for different subpopulations doesn't mean that a rulemaking must be initiated.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes, I think that people don't understand the issue. The real issue for the FDA is scientific and clinical data. None of the data supports the current decision to initiate a rulemaking. There is not data showing the "toxicity or other potentiality for harmful effect" of Plan B. Its methods of use are simple and have been shown to be readily comprehensible to the general population. This application does not fulfill any of these requirements.
C. If so, would a rulemaking on this issue help dispet that confusion?
No, because the rulemaking is unnecessary for the reasons I explained 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?
Legally, a two tier system could be enforced as it is for many other drugs, such as the examples listed in the decsion.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes, for the same reasons as in A.
GENERAL
GENERAL
[2005N-0345] As a member of the scientific community, I am appalled by the lack of scientific and medical basis for this decision. The scientific data shows no toxicity, the drug is safe, the drug is simple to take, label comprehension is good; there is no reason based on the available data to no have approved this drug. Therefore, it is logically only possible to conclude that something other than science is driving the decision by the commissioner. Whatever these other forces are - political pressure, religions, whaterver - these are not the purview of the FDA. The FDA is supposed to ensure that safe and effective drugs reach the consumers. This drug is both safe and effective. The FDA does not and should not regulate morality and individual behavior. There is absolutely no valid reason why Plan B was not approved. Therefore, a rulemaking is unneccessary and only serves to delay this safe and effective product from being marketed, a contradiction of the FDA's purpose. There should be no rulemaking initiated and this decision should be reconsidered.