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.