|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 :||EC650|
|Submitter :||Mrs. Virginia White||Date & Time:||10/12/2005 06:10:36|
|Organization :||Concerned Women for America|
|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?|
| 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?|
|B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?|
|C. If so, would a rulemaking on this issue help dispet that confusion?|
|I hope so|
| 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?|
| Yes, by asking for ID such as is done for liquor and cigarettes. Also Doctors would be responsible not to prescribe RU 486 to minors.
Actually, the product is harmful to all women, no matter what age, and should not be sold at all. There is plenty of evidence for this.
|B. If it could, would it be able to do so as practical matter and, if so, how?|
|Same as A|