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 : EC874
Submitter : Ms. Mary Hartigan Date & Time: 10/17/2005 10:10:16
Organization : Ms. Mary Hartigan
Category : Individual Consumer
Issue Areas/Comments
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 current process is reasonable and clear. The only reason it did not work for Plan B is because the process was intended to fail. No procedure is proof against active sabotage from within.

Of course, a decision that a full review and rule making are "necessary" before proceeding would be an excellent way to delay action on Plan B and to ensure that political critera are central to future rulemaking on all devicies and drugs. Perhaps a requirement that all future drugs and devices undergo a religious test to ensure that they did not result from the application of evolutionary biology would also be appropriate.
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. Same reason as above.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No more than was intended by the process. There is no cure for bad-faith implementation of a procedure or process.
C. If so, would a rulemaking on this issue help dispet that confusion?
The only confusion with regard to current interpretation of section 503(b) was intended by the FDA political staff and no rule making could cure that.
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?
I have heard no cogent argument as to why the FDA could not enforce such a limitation.
B. If it could, would it be able to do so as practical matter and, if so, how?
Have it sold from behind the pharmacy counter and require proof of age for persons who appear to be under 21.
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?
A stick-on label for the prescription only version containing an age appropriate warning would be a sufficient change in packaging.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
I support the over the counter sale of the emergency oral contraceptive ?Plan B.? This pill is not an abortificant and, in fact saves women from developing a crisis pregnancy. The age of the person trying to avoid conception is irrelevant.

The 'reasoning' that not enough testing had been done in the 14-16 age population is specious. I'll warrant that men between 22-40 were not tested either. Nor, likely, women over 80. The age issue is entirely politically motivated and is not calculated to better the health and life of women.

I cannot understand why anyone would delay the availability of this medicine. Apparently, the FDA is in the grip of a radical right wing ideology that elevates one set of religious beliefs to the level of a State Religion. We now have a situation that when facts and science provide answers, these answers must be denied in deference to the extreme religious beliefs of a tiny minority. If that minority is right ? that medicines which prevent conception are ?murder pills? - then the FDA should also prohibit doctors or other health care professionals from suggesting or facilitating breastfeeding or from prescribing a whole host of medications and treatments that might conceivably somehow interfere with female fecundity.

Stop the delay, approve OTC sale of Plan B.