2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC1903
Submitter : Dr. Paula Hillard Date & Time: 10/31/2005 04:10:03
Organization : Cincinnati Children's Hospital Medical Center
Category : Health Professional
Issue Areas/Comments
The scientific community has viewed, reviewed, and examined the evidence in favor of over-the-counter status of Plan B. There is consensus and agreement that the product is safe, effective, and would prevent abortions. The arguments about a differential effect among younger teens are not based on science, but on prudish notions that younger teens should not be having sex. The American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the Society of Adolescent Medicine all support over-the-counter status, as do over 70 other medical organizations. The FDA's own staff and advisory panel support over-the-counter status.
The failure to approve this safe and effective medication has called the FDA's credibility into question, and is undermining the scientific credibility of the organization.
This drug should be approved for ALL populations for over-the-counter status.
As a member of another FDA advisory committee, I have concerns about whether I can or should continue to serve in that capacity when the advice and scholarship of my scientific colleagues on another FDA committee are being ignored.
The scientific evidence supports approval of Plan B for availability over-the-counter. Only the blindness of politicians and political appointments prevents the scientific truth from becoming a reality that has been estimated to have the ability to prevent ONE MILLION abortions per year in the United States.