2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
  


  

  


  

  
FDA Comment Number : 
  

  
EC834
  



  

  

  



  

  
Submitter : 
  

  
Dr. Peter Horvath
  

  
Date & Time: 
  

  
12/10/2004 03:12:52
  



  

  
Organization : 
  

  
Albany IVF, Fertility and Gynecology
  



  

  
Health Professional
  


  

  
Category : 
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Personal behavior pervue has always and will always be at the foundation of 

what the FDA does.  It was founded to protect and promote the health of the 

public, which always must take into account the behavior of the public.  There 

is  no question that OTC Emergency Contraception will result in increased 

sexual activity, especially by teenagers.  There will be immense peer 

pressure by males on teenage women to have intercourse because this 

product is readily available, and is somewhat effective.  The inevitable 

increased sexual  activity will result in increased STD's, without the woman 

ever having to see a doctor.  Untreated STD's will result in destroyed fertility 

for many women.   And this will obviously become a "date rape" drug of 

choice.  OTC approval  would be very poor public health policy indeed.



In the 3 or 4 years after EC became OTC available in Sweden, the teen 

abortion rate increased by 31% and the teen Chlamydia rate increased by 

30%.  Post marketing surveillance in Great Britain showed a tripling of ectopic 

rate to 6% among 200 "failed" (Pregnant) EC users.  At the very least, Barr 

Laboratories should be asked to demonstrate with adequate studies that 

abortion rates, STD rates and ectopic pregnancy rates are not increased in 

EC users as compared to non users.  Anything less would be irresponsible 

public health policy.



Certainly FDA considerations must go deeper than simply "Is levonorgestrtel 

dangerous for a woman's health?"  You must ask, and Barr Laboratories must 

show, if OTC availability of this product is in the best overall health interest of 

the women who would be using it, or if in fact its use fosters is a health risk for 

increased STD's, increased abortion rates, and increased ectopic pregnancy 

rates.