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 : EC510
Submitter : Dr. J Michael Davidson Date & Time: 09/27/2005 08:09:52
Organization : Advanced Women's Care
Category : Health Professional
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?
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?
As a health care professional actively engaged in the prescribing of this product it is my professional opinion the FDA could not enforce the limitation of prescribing to a subpopulation by prescription only. It is a matter of law that minors shouldn't be able to obtain tobacco products but most minors can readily obtain tobacco products. This product should be prescription only in all circumstances because of the health related issues. There are no studies that show a reduction of unwanted pregnacies or a reduction in abortions with this product available over the counter. In England there is a study showing an increase in the ectopic pregnancy rate in a population using the Plan B type product 'over the counter'. The best explanation for that is an increase in untreated sexually transmitted disease in this population.FDA Docket 2005N-0345
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?
No.
GENERAL
GENERAL
As a practicing OB-GYN physician I urge you not to allow Plan B to be available over the counter. There are no studies that show a decrease in unintended pregnacies or a reduction in abortions when this product is available over the counter. The fear of most OB-GYN M.D.'s is an increase in sexually transmitted diseases because health care screening is no longer required. A study in England has shown an increase in the ectopic pregnancy rate in a population when Plan B type medications were available over the counter. The logical explanation for this is an increase in undiagnosed and untreated sexually transmitted diseases. There is also the significant potential for older male teens to obtain the plan B product
over the counter and then pressure younger teen females for sexual activity. I urge you not to make Plan B or any other oral contraceptive type product available over the counter as a practicing physician in this area of health care. It will be bad public policy and has the potential to cause harm with no documented impovement in unintended pregancies. FDA Docket 2005N-0345