2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC863
Submitter : Mr. Matthew O'Brien Date & Time: 12/10/2004 04:12:39
Organization : Dept. of Philosophy, University of Texas at Austin
Category :
Issue Areas/Comments
I strongly encourage the FDA to reject Barr Laboratories' application to have the status "emergency contraceptives" (ECs) altered from Rx to OTC. Firstly, post marketing studies of ECs in the United Kingdom have showed a tripling of ectopic pregnancy rate to 6% among 200 "failed" (ie, pregnant) EC users. EC use is a health risk to women. Furthermore, from what I understand in the 3 or 4 years after EC became OTC available in Sweden, the rate of abortion among teenagers grew by 31%, and the Chlamydia-infection rate among teens increased by 30%. This data suggests that even apart from ECs' harmful effects on womens' health, the further social consequences of OCT availability are grave. It will encourage promiscuous and irresponsible sex (especially among teens) through being seen as a reliable "back-up" to pregnancy prevention, especially since OCT availability of EC will by beyond the oversight of medical professionals. Restricting purchasing rights to teens 16-years-old and above will be effectively impotent in keeping ECs from even younger teens. (A drinking age of 21, for instance, certainly does not keep younger college students from acquiring alcohol.)

Again, I strongly encourage the FDA to delay in approving the status change of emergency contraceptives. At the very least, Barr Laboratories should bear the burden of demonstrating through social scientific evidence that OCT availability of ECs in other countries has not contributed to the increase of the sorts of medical and social harms I mentioned above.


Matthew B. O'Brien
Doctoral Candidate
Department of Philosophy
University of Texas at Austin