|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|
| 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.