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 : EC942
Submitter : Dr. Anne McBride Date & Time: 10/27/2005 08:10:48
Organization : Dr. Anne McBride
Category : Individual Consumer
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?
No
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?
No
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
Only in so far as why Plan B, a female-specific medication, should have raised the rulemaking query when the prescription-to-OTC procedure, when backed by sound scientific and medical evidence as is the case for Plan B, has moved smoothly in so many non-gender-specific cases.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. It would further obscure the problem.
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.
B. If it could, would it be able to do so as practical matter and, if so, how?
Yes. It could be kept behind the counter at pharmacies and ID could be required for purchase. Plan B is much less harmful than alcohol!
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, if this is the case with other medications (e.g. high doses of ibuprofen).
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
None.
GENERAL
GENERAL
I am appalled by the delay in approving Plan B for over-the-counter status for the following reasons:
1. All scientific and medical evidence points to its efficaciousness and safety.
2. Despite the clarity mentioned above, it has become mired in a bureaucratic morass that other non-female-specific medications/devices have escaped in the transition from prescription to OTC use. The FDA is a critical institution for the health and safety of Americans, yet these two considerations have taken a back seat to other motives, as evidenced by this rulemaking inquiry.
3. The availability of OTC emergency contraception will help prevent unwanted pregnancies that might otherwise result in abortion. Imagine an 18-year-old woman raped by a family member and unable to go to a doctor for a prescription. Why should abortion or being forced to bear a child from such a horrific experience be more allowable options than Plan B?
Public health decisions (and other scientific decisions) need to be made by independent governmental bodies that evaluate the SCIENTIFIC evidence and make decisions based on that evidence. Otherwise we might as well be living in the 14th century (antibiotics not withstanding).
We cannot let vague ideological motives trump science!
Therefore, I urge the FDA to approve Plan B for over-the-counter use by all women.

p.s. I'm also saddened, if not shocked, by the fact that I had to know the exact number of this call for comments in order to find it on the FDA website. Obfuscation to stifle dissent also points to the need for reform and an emphasis on science rather than politics.