2001P-0075 - Switch Status of Emergency Contraceptives from Rx to OTC
FDA Comment Number : EC772
Submitter : Ms. Teresa Harrison Date & Time: 06/10/2004 05:06:04
Organization : Ibis Reproductive Health
Other Organization
Category :
Issue Areas/Comments
I am pleased to submit a comment about the FDA?s decision to issue a non-approvable letter in response to Barr Laboratories? application to sell the emergency contraception (EC) product Plan B? over-the-counter (OTC) to reduce the risk of unintended pregnancy. I comment on behalf of Ibis Reproductive Health, a non-profit organization based in Cambridge, MA, that conducts clinical and social sciences research, analyzes public policy, and advocates for medical reform. Based on the substantial clinical evidence supporting the safety and efficacy of Plan B, we support the availability this product without a doctor?s prescription. The research on this product is clear, but your decision does not reflect this and we have concerns about the decision-making process.

The recent decision to reject Barr Laboratories? application suggests that the FDA did not rely upon the scientific data nor upon the recommendations made by members of the two FDA expert advisory panels. Scientific evidence demonstrates that Plan B is a safe and effective product, and leading medical authorities agree that it should be available OTC. The overwhelming majority of the advisory panel members recommended making Plan B available OTC for all women, not just those of a certain age. With such strong support from the medical and public health communities, we can only guess that politics have superseded science in the FDA?s decision-making process.

In its letter to Barr Laboratories, the FDA states that Barr must provide data demonstrating that Plan B can be used safely by women under age 16 without the professional supervision of a licensed practitioner. We would like to point out that there is no evidence of adverse effects among women under age 16 in the six states where the method is available through pharmacists or in studies evaluating EC use among adolescents. Even if teenagers use the product on multiple occasions, the potential consequences (e.g., menstrual irregularity, nausea, vomiting) are minor compared to the health risks associated with carrying a pregnancy to term and the social costs of having an unintended pregnancy at a young age. The high rate of unintended pregnancies and abortions among teenagers in the United States should serve as reminder that adolescent females are already having sexual intercourse and are in need of timely access to Plan B.

We are also concerned that rejecting Barr?s application for Plan B sends the message that the product must be dangerous. It is particularly illogical to deny women access to a product that is far safer than carrying an unintended pregnancy to term.

Ibis Reproductive Health supports efforts to increase women?s access to safe and effective methods of contraception. There is no evidence that requiring women under age 16 to have a prescription for Plan B improves women?s health outcomes. If anything, obtaining a prescription increases medical costs and decreases access to the product, both of which increase the chances of an unintended pregnancy. For these reasons we support OTC status for Plan B.

Thank you for the opportunity to comment.


Teresa Harrison, SM
Project Manager