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 : EC1904
Submitter : Dr. Scott Spear Date & Time: 10/31/2005 04:10:17
Organization : UW-Madison
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?
This process seems meant to delay and obfuscate a decision on OTC status and I strongly recommend that the rulemaking process be abandoned.
Plan B is a safe and effective method of emergency contraception for all women at risk of unintended pregnancy and should be available over-the- counter without regard to age. The evidence for OTC status for Plan B is overwhelming and is in line with the advice of the FDA advisory panels and many staff members within the FDA itself. To continue to prevent this product from being available OTC severely damages the scientific credibility of the FDA and appears to allow extremist political forces to hold sway over sound medical care for women in this country.