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 : EC2153
Submitter : Ms. Mariann Schmitz Date & Time: 10/31/2005 06:10:25
Organization : Ms. Mariann Schmitz
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?
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?
No
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
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
I am writing to voice my anger that the Food and Drug Administration (FDA) has delayed again its decision on whether to approve the emergency contraceptive (EC) Plan B for over-the-counter sales. The scientific evidence is clear: emergency contraception is safe, meets all of the FDA's requirements for over-the-counter status, and is up to 95 percent effective if used within the first 24 hours after unprotected sex, birth control failure, or sexual assault. There should be no further delay; I urge the FDA to approve Plan B EC immediately for over-the-counter sales without age restrictions.

Unintended pregnancy is a significant public health problem in the United States. Plan B is a safe, effective, and easy-to-use contraceptive option that will help reduce the need for abortion. Accessibility is of the essence. The sooner EC taken, the more effective it is.

Greater access to EC will reduce the number of abortions in the United States, and failure to approve a product that would reduce the number of abortions is working against the government?s own professed goals.

Scientific research has overwhelmingly demonstrated the safety, efficacy, and need for emergency contraception over-the-counter for women of all ages. Women in this country deserve the same unencumbered access to EC that women in 39 other countries around the world already enjoy. Many women, including survivors of rape, will benefit from increased access to this backup method of birth control.

The FDA has specifically asked for public comment on three issues: Should the FDA create and define a regulation to allow for a drug to be available both with a prescription and without? Does the FDA have the authority or ability to enforce restricting a drug from a subpopulation when it would be available to the larger population? Can a drug that is approved both with a prescription for some and without a prescription for others have the same packaging, or would it require different warning labels and instructions?

The short answers as they relate to Plan B Emergency Contraception are no, no, and no. Nor is it appropriate for the FDA to keep over-the-counter EC access from American women by using these questions as a dodge.

Every day the FDA delays making a decision to allow increased access to this second-chance prevention medication, more women are put at risk of unintended pregnancy.

Americans deserve an independent FDA that will protect our health and make public health decisions based on science and medicine, not ideology. To sacrifice the health and lives of women to promote an ideological agenda is simply unconscionable. Major medical groups along with the FDA's own scientific and medical experts overwhelmingly support this move. If for no other reason than to protect the integrity of its own work and public confidence in it, the FDA must not allow anti-choice ideology to corrupt science.

I urge the FDA to move immediately to change the distribution status of Plan B EC from prescription to over-the-counter status for all women of all ages.

Thank you for your attention