CRR takes the FDA to Court

05 Dec 2011 3 Comments

by womenhealthpros in Birth Control, Emergency Contraception, women's health Tags: birth control, emergency contraception, FDA, preventing pregnancy, womens health

When it comes to emergency contraception, the FDA (Food and Drug Administration) has a questionable past. Back in 1999 the FDA approved Plan B as emergency contraception by prescription only. At the Start of 2001 the Center for Reproductive Rights filed a Citizen Petition to have them reconsider this and make it available as an OTC (over-the-counter) medication and two years after the Plan B’s manufacturer filed a petition with the FDA to get OTC status.

While a panel of FDA experts recommended approval of OTC status, the head of the office in charge of the final decision told his employees that normal procedure would not be followed and they would not be making the decision. The FDA then denied the application and recommended the manufacturer re-file the application for OTC status for women over 16 only. Pretty shady huh? Well while all this was going on the head of this department Dr. Steven Galson, told a colleague that he had to deny the application or risk losing his job. Also during the time, the second most important person at the FDA during this time Dr. Janet Woodcock told a colleague that they have to deny the application and later approve it with an age restriction to “appease the administration’s constituents.”  They manufacturer did re-file with an age restriction did but by 2005 the FDA still had not approved it.

The Center for Reproductive Rights then filed a lawsuit against the FDA for letting politics determine their decisions instead of science. In 2006, with the lawsuit still pending, the FDA approved Plan B for women 18 and older as an OTC medication. In 2009 a New York court orders the FDA to approve Plan B for women 17 and older without a prescription and to reconsider the Citizen Petition filed in 2001. Also in 2009 the FDA approves Plan B, the new Plan B One-Step, and Next Choice ( a generic brand of Plan B) for women 17 and older without prescriptions but still requiring them for women 16 and under. In 2010 a new brand of emergency contraception Ella, is approved for women by prescription only. The Center for Reproductive Rights filed a motion to have the FDA found in contempt of court for failing to reconsider the Citizens Petition.

This ten year back and forth seems poised to be ended by the end of this year. The motion to have the FDA held in contempt of court will be heard on December 13. While the hearing relates specifically to Plan B the Center for Reproductive Rights has an online petition going to have the FDA also remove the age restriction and prescription requirement from Ella. That is a lot of information so if you’re interested in seeing it in a timeline check out this page on the CRR’s website. While you’re at it sign their petition to get all emergency contraception approved for OTC sale as well including Ella.