Originally published December 12 2005
GAO finds inconsistencies in FDA decision regarding Plan B
by Mike Adams, the Health Ranger, NaturalNews Editor
FoodConsumer.org reviewed the process leading up to the FDA's denial of over-the-counter status to the Plan B Contraceptive and found some irregular procedures that would suggest politics triumphed over science.
In April 2003, Women's Capital Corporation submitted an application to the Food and Drug Administration (FDA) requesting the marketing status of its emergency contraceptive pill (SCP), Plan B, be switched from prescription to over-the-counter (OTC).
In May 2004, the Acting Director for the Center for Drug Evaluation and Research (CDER) issued a "not approvable" letter for the switch application, citing safety concerns about the use of Plan B in women under 16 years of age without the supervision of a health care practitioner.
Because the not-approvable decision for the Plan B OTC switch application was contrary to the recommendations for FDA's joint advisory committee and FDA review staff, questions were raised about FDA's process for arriving at this decision.
GAO was asked to examine (1) how the decision was made to not approve the switch of Plan B from prescription to OTC, (2) how the Plan B decisions for other proposed prescription to OTC switches from 1994 through 2004, and (3) whether there are age-related marketing restrictions for prescription Plan B and other prescription and OTC contraceptives.
FDA review officials noted that the agency has not considered behavioral implications due to differences in cognitive development in prior OTC switch decisions and that the agency previously has considered it scientifically appropriate to extrapolate data from older to younger adolescents.
The Food and Drug Administration (FDA) today acknowledged that it has issued a "Not Approvable" letter to the sponsor of an application to make the Plan B emergency contraception product available without a prescription.
The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs, presented us with many difficult and novel policy and regulatory issues.
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