2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC708
Submitter : Dr. Mark Beauchamp Date & Time: 04/13/2004 12:04:12
Organization : Lovelace Health Systems
Health Professional
Category :
Issue Areas/Comments
I urge the FDA to proceed directly to full and unconditional approval of levonorgestrel for OTC availability without any conditions of availability to the consumer, such as selective placement of the drug within the pharmacy.
It appears that the FDA is acting under the influence of political pressure from the Bush Administration to defer approval of the drug. The reactionary and anachronistic position of the current administration with respect to reproductive issues is well known.
It behooves the FDA to resist political pressures of this sort and proceed apace with the approval of any drug with a useful application and demonstrated safety profile.