2005-2006 Regular Session 1st House HR 4229

Summary: The bill would require the FDA Commissioner to issue a decision on the application by Plan B's manufacturer to allow over-the-counter sales of the emergency contraception drug.  

What You Should Know: Emergency contraception (EC, also known as the "morning-after pill"), which prevents pregnancy by blocking ovulation and fertilization if taken within 72 hours of unprotected sex, is currently available without a prescription in over 25 countries. An application to make the emergency contraceptive Plan B available over the counter in the United States was submitted to the Food and Drug Administration (FDA) in April 2003, and eight months later, two separate FDA expert advisory committees voted 23-4 to accept the application. Despite these recommendations, in May 2004, then-acting FDA Commissioner Lester Crawford rejected the application, over the protests of scores of physicians, including the American Academy of Pediatrics. At the FDA's recommendation, a second application was submitted to allow over-the-counter sales of Plan B only to those over the age of 17, and during Crawford's confirmation process as FDA Commissioner, he promised a final decision on the matter by September 1, 2005. But on August 26, 2005, the FDA once again refused to accept an application to switch Plan B to over-the-counter status. The Governmental Accountability Office described the FDA's rejection of Plan B as "not typical of the other 67 prescription-to-OTC (over-the-counter) switch decisions made from 1994 through 2004."

Update: After three years, Plan B was approved for OTC status in August of 2006, but only partially -- an unprecendented rule was set by FDA allowing OTC sales only to women over 17. Minors will still have to get a prescription for it.

Primary Sponsor(s): Rep. Carolyn Maloney (D-NY)

Introduction Date: 11/3/2005

Last Major Action:

11/3/2005. Referred to the House Committee on Energy and Commerce.