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 : EC975
Submitter : Ms. Chrisula Tasiopoulos Date & Time: 10/27/2005 09:10:18
Organization : Sexual Assault Support Services
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?
I don't sufficiently understand section 503(b) enough to answer that question.
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?
I don't sufficiently understand section 503(b) enough to answer that question.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Yes.
C. If so, would a rulemaking on this issue help dispet that confusion?
A rulemaking may help, but that would also depend on what this "rulemaking" actually is.
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?
Yes, a law could be developed, but the FDA would still be limiting access and availability of Plan B to those women with health insurance with doctors and pharamacists who would be willing and nonjudgmental and unbiased.
B. If it could, would it be able to do so as practical matter and, if so, how?
It would not be practical. Many women who need this drug have recently been sexually assaulted. In this case, Plan B MUST be administered within 72 hours of penetration. Within those 72 hours, many victims are still experiencing emotional and cognitive disturbances and may not have the strength to get to a pharmacy that would carry this medication. That being said, regardless if this woman needs Plan B to prevent a pregnancy
as a result of a sexual assault, women would need to find a doctor who would prescribe it, and a pharmacy that carries it and dispenses it without question. There remains a high risk of experiencing bias for medication that women need, when many (if not all) pharmacies carry Viagra and do not torment or yell at men who are there to fill that prescription. Removing limitations and permitting more access to this medication means women truly have equal access to medications that they need and should be able to visit a local pharmacy to obtain.
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?
Yes, why not?
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
It would not be inappropriate to do so in any circumstances.
GENERAL
GENERAL
It is absurd that the American government has stalled the availability of Plan B as an OTC medication for this long. Working with women who are survivors of sexual violence, or women who have little to no resources has taught me a great deal about how government can greatly impact your health and life in general by restricting or limiting certain medications, and in essence, certain rights. Women are not a "subpopulation", they are a population to be respected and treated with dignity and not be restricted, especially when it comes to healthcare. We have a wonderful country here in the U.S., yet the status of women continues to denegrate through avenues such as violence and unequal access to healthcare. Healthcare is based in science and should NOT be affected by personal values, beliefs, or reflect a particular relgious ideology. The U.S. government should not intervene based on values, beliefs, or a particular religious ideology. Emergency contraception has been put on the back burner for too long because of these things, and it's insulting to think that this has happened because a largely white male government does not want it to become available. The FDA needs to listen to women, and needs to listen to those professionals who possess sound educational and experienced backgrounds in WOMEN'S HEALTH, not veterinary science or some other totally unrelated field. This is long overdue. Please listen to women and stop stalling on this already!