FDA Fails To Consider Risks Of Over The Counter Plan B

Main Category: Sexual Health / STDs
Also Included In: Regulatory Affairs / Drug Approvals;  Women's Health / Gynecology;  Pharmacy / Pharmacist
Article Date: 24 Apr 2009 - 5:00 PDT

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Moira Gaul, Family Research Council's Director of Women's and Reproductive Health, released the following statement regarding the Obama Administration's decision to sell the morning-after-pill to 17-year-olds without a prescription.

"The Obama Administration is permitting a judge to make a scientific decision as to the safety of the over-the-counter sale of Plan B. This decision places policy preferences before safety. The best interest of women's health is not advanced by these decisions. Reason, science, and compassion clearly are not the animating factors of the decision.

"In order for a drug to be sold over-the-counter, patients must be able to safely medicate themselves without medical supervision. Studies tracking the label comprehension for Plan B show poor awareness that Plan B is not a substitute for standard contraceptives. The FDA-approved label for Plan B gives no clear indication that repeated use of Plan B in a short period of time is not safe.

"FDA officials understood these safety concerns in 2006 and were not convinced that the label comprehension data for teens demonstrated that they could use Plan B safely. The FDA officials believed more data needed to be submitted.

"There is a real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent. Interaction with medical professionals is a major screening and defense mechanism for victims of sexual abuse. The availability of Plan B over-the-counter also bypasses the necessary routine medical care of sexually active girls and women, which is important for the screening of health conditions, and for providing screening for sexually transmitted diseases."

Source: Family Research Council

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