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FDA on EC access

This article was originally published in The Tan Sheet

Executive Summary

FDA "has never made" the statement that wider access to Plan B could lead to increased promiscuity in women under the age of 16, the agency states in recent letters to members of the House Pro-Choice Caucus. In October, 62 members of the caucus wrote to FDA stating that the agency cited the concern in its May 2004 "not approvable" letter to Barr regarding the firm's switch application. "You attribute to FDA a concern that the agency has never expressed about the proposed Plan B switch to OTC status and we would like to correct the record on this matter at this time," FDA states in a response sent to each signatory of the October letter. The May 6, 2004 memo from CDER Acting Director Steven Galson explaining his decision to find Plan B not approvable notes a lack of studies submitted by the sponsor to address "important potential behavioral changes," including "increased medically risky sexual behavior"...

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