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 : EC934
Submitter : Ms. Paula Cullen Date & Time: 10/27/2005 08:10:55
Organization : Ms. Paula Cullen
Category : Health Care Association
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?
The FDA should not change its current policy. The current situation with Plan B is a good example. Minors already have unrestricted, unregulated access to the so-called 'Morning After Pill' in Washington State where Plan B is readily available 'behind the counter' (no prescription required, but should be obtained from a pharmacist). Even this safeguard is ignored, however. For example, the Department of Social and Health Services (DSHS), through its alliance with Planned Parenthood, distributes Plan B to women on public assistance without any type of medical consultation. We have evidence of this from our own clientele who have brought their 'brown bags' to us that they were given at the public assistance offices. These bags contained condoms, several doses of Plan B, and other information on contraception.

We know from our 24 hour helpline and from our clinic practice that teenagers are using Plan B more often than they should. Some use it as their primary form of birth control, sometimes taking it several times a month. Since Plan B is widely available here without regulation (even though consumers are supposed to consult with a pharmacist to obtain it), it is possible to use it more frequently than recommended.

Furthermore, the standard of care before prescribing any type of contraception, including the 'Morning After Pill,' should call for sexually transmitted disease (STD) assessment. Minors are more vulnerable to STDs because of the immaturity of their reproductive system. The dual implication of increased risk of STDs in minors and the likely increased sexual activity that easy access to EC affords, makes OTC distribution unwise.

There are good reasons why prescription drugs require a physician's assessment and a written order. The above reasons illustrate that point.
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. See previous comment.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
No.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. It would only confuse the issue further, and compromise the health of those who are vulnerable.
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?
No. Many women in the so-called "sub-population" (e.g., adult women) may still have significant risks for STDs, and/or other health concerns, such as cardiovascular risks. All women should have a medical evaluation before they are given prescriptions for EC, regardless of their age.
B. If it could, would it be able to do so as practical matter and, if so, how?
EC should not be available OTC.
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?
EC should not be available OTC.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
EC should not be available OTC.