Monday, the FDA issued a statement declaring it would approve Plan B One Step (a form of emergency contraception) for over the counter sale without restriction.
It is about time.
This decision allows science to trump politics and emotion.
Plan B One step is a single dose of levonorgestrel, a hormone used in oral contraceptive pills (OCPs), that when taken within 3 days of unprotected sexual activity is effective in reducing the chance of pregnancy.
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It works in a similar matter to oral contraceptives that are taken daily (though less effective than regular use of OCPs).
It is NOT an abortifacient.
Emergency contraception (EC) has been available in the United States since 1999. At that time it was only available with a prescription.
In 2009 it became available for those over 17 without a prescription, and retained its prescription status for those younger than 17.
There are decades of data on the safety of emergency contraception. There is no situation in which the risk of EC (whether combined hormones or a single hormone such as Plan B) outweighs the benefits.
Numerous studies have attested to the safety of levonorgestrel: there are NO reported deaths nor serious complications.
The Center for Drug Evaluation and Research (CDER) carefully considered whether younger females were able to understand how to use Plan B one step.
CDER determined, after looking at all the scientific evidence, that adolescent females understood that EC is NOT for routine use, and that the product does not protect them against sexually transmitted diseases.
The scientific data also show that young adolescent females could use the product properly without the intervention of a healthcare provider.
In 2011, after reviewing the process used by CDER, the FDA was ready to make Plan B One-Step over the counter (OTC) without restrictions.
In an unprecedented move, the Secretary of Health and Human Services intervened and prevented Plan B One Step from attaining OTC status. This was not a decision based on the scientific evidence.
Emergency contraception (EC) is sold over the counter in 6 countries and is available directly from a pharmacist without a prescription in 54 countries.
Studies have shown that repeated use of EC is safer than pregnancy, particularly when pregnancy is unintended.
In the United States nearly 50% of pregnancies are unintended. Studies have shown that easier access to contraceptives reduces unintended pregnancy rates (and abortions).
Not only are the concerns about whether young adolescent females can comprehend how to use EC demonstrably false, this is a group that needs access to health care that is proven to be safe and effective.
If a young girl is sexually active, whether by choice or not, she should not be denied reproductive rights. She should be allowed to make timely reproductive decisions about her own body within the dictates of her religious and moral codes.
To deny young adolescents access to medically necessary and proven care is essentially reproductive slavery.
The FDA joins physicians and scientists including: the American Medical Association, the American Academy of Family Physicians, the American College of Obstetrics and Gynecologists, the American Academy of Pediatrics and the Association of Reproductive Health Professionals in its support of making Plan B over the counter without restrictions.
Finally, science trumps politics.
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