2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC761
Submitter : Dr. Thomas Fekete Date & Time: 05/14/2004 06:05:11
Organization : Temple University School of Medicine
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
The press reported that the FDA acted in opposition to the recommendations of its Advisory Committee in failing to approve the transfer of levonorgestel from prescription only to OTC sale. After reading the editorial by Drazen, et al. in the New England Journal of Medicine on April 8, 2004, I was moved to comment on this topic. Since then, I read the letter by Dr. Galson to Barr Laboratories on the reason for this failure to move the drug to OTC status and I was struck by several things. First there was no comment about whether the drug had been associated with ANY problems other than the known side effects in the years that it has been available. I was also stuck by the lack on interest in the experience of levonorgestrel in other countries. Third, I was impressed by the complete LACK of data on pregnancy related toxicity in girls of the age range that the FDA found levonorgestel to be potentially problematic. Fourth, I was impressed by the lack of any credible specific reason why this form of emergency contraception might be dangerous.

Normally the decision to withhold approval of a drug for OTC status should weigh the advantages vs. the disadvantages of such a move. There was absolutely no quantitation of any potential advantage vs. disadvantage in Dr. Galson letter of disapproval.

If you asked how to reject a drug for political purposes as opposed to scientific ones, you could not do better than to cite the experience illustrated by Plan B. The FDA should not be proud of this moment in its history.