by: ASRM office of Public Affairs
Published in ASRM Bulletin Volume 15, Number 20
The Obama Administration has decided to stop fighting to put age limits on who can purchase emergency contraception without a prescription. The decision comes after the Second Circuit Court of Appeals ordered that the U.S. Food and Drug Administration to comply with a previous court decision making the two-pill emergency contraception available over the counter and without age restrictions.
The recent debate over emergency contraception began in December 2011, when a panel of scientists at the FDA determined that Plan B One Step is safe and effective for over the counter use by all females, but Secretary of Health and Human Services Sebelius overruled that decision, requiring the age restriction to remain in place.
The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
ASRM applauds the Administration for dropping its opposition to age limited access to emergency contraception and for putting science before politics. ASRM’s position is that drugs for reproductive purposes should not be treated differently than drugs for other medical purposes.
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