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 : EC876
Submitter : Mr. Steven Armstrong Date & Time: 10/17/2005 10:10:41
Organization : Mr. Steven Armstrong
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?
GENERAL
GENERAL
Any families with teen girls should have access over the counter to Plan B, as should any women of childbearing age. Girls and women of all ages continue to be overpowered by callous men (of all ages) sexually, and these women should not be denied full control of their reproduction cycle. Plan B helps the women flush the horror away of rape, conquest, humiliation, and loss of control.

As a parent, and health professional in training, I can't understand the lack of action and endless delays by the FDA for something that seems desperately needed. The scientific committees have approved it, safety tests passed. I recall how quickly Viagra and Cialis got approved, but the FDA shows no balanced approach for women.

This morning, our papers carried a story of a neighbor, a 13 year old girl, who was overpowered and raped on a nearby bike trail by two older teen boys, who took turns being lookout and attacker. The two boys can't be found, premably now across the state line. What options will the FDA allow this girl, a young woman whose vulnerability was exploited shameless by a couple of uncaught criminal males? The unjust deed was done and the heavy burden and pain falls all upon the 13 year old girl and her family. Such stories of unwanted male agression against young girls happen in every part of America and such stories precipitated the need for Plan B.

Making Plan B avaible allows a young woman to prevent the nightmare from being implanted and prevents the horrible story being extended for a lifetime of shame. Plan B gives the young girls a critically needed way to regain some control over the chain of life-distorting events thrust upon their lives by male criminals. All women deserve the chance to safely reject unwanted impregnation using a safe and sound medication available on demand, over the counter.

Until the FDA offers a general over the counter cure for male sexual aggression, women of all ages deserve an over the counter Plan B to limit the family, generational and lifetime consequences of a few minutes of unwanted male aggression. Plan B gives young girls, too immature to give birth, an way to ensure their health and welfare, maybe even lives, can be preserved. Do not blockade the door to Plan B for vulnerable women for one more day.