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 : EC390
Submitter : Ms. Tina Fought Date & Time: 09/20/2005 04:09:15
Organization : ACNM
Category : Health Professional
Issue Areas/Comments
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 stall of providing Plan B OTC based on is compounds including prescription drug product represents a double standard. There are countless prescription products that are contained in OTC products as well. Should aspirin be presented to the FDA in 2005, it would be a prescription product only. Access to care and birth control products representing reproductive choice has been in the hands of legislative officials for far too long. It is incredulous that a mechanism that would prevent unintended pregnancies and abortions would be delayed time and again on the misinformation that this product would promote promiscuity, teenage sexuality, STD's and illicit sexual practices. I urge this audience to put aside their ideologies that are based on erroneous information about this product and the belief that "scare tactics" will change sexual practices of youth. Furthermore, consider the position this places "women of legal age" access to a form of emergent birth control. There is no greater tragedy to a woman than the emotional turmoil of an unintended pregnancy. I urge you to expedite a favorable decision in the position of Plan B.