FDA Rejects Plan B OTC
• Reproductive Drugs and OTC Advisory Committees
met Dec 16, 2003
• Voted “Yes” to place Plan B OTC (23 to 4)
• Plan B is safe, effective, and easy to use
• FDA sent manufacturer a Non-Approvable Letter in
May 2004
• ACOG and other organizations express dismay at
the FDA’s decision, suggesting political agenda
FDA transcripts. Available at:
http//www.fda.gov.ohrms/dockets/ac/03/transcripts/4015T1.DOC
Dickerson VM. ACOG News Release. Available at:
http://www.acog.org/from_home/publications/press-releases/nr05-07-04.cfm