FDA overruled in decision on contraceptive

In what was called a “rare” and “politicized” split between the FDA and the Health and Human Services Department, emergency contraceptives will still require a prescription for those under 17 years old.

Kathleen Sebelius, the HHS secretary, overruled the FDA conclusion that Plan-B One Step was safe for younger girls to use as an over the counter medication. This was the first time the department’s secretary has overruled and FDA commission in policy decisions. Both the FDA and Sebelius issued dueling press statements, spurring on the dueling coverage in the press.

A Fox News opinion columnist called the decision miraculous, saying “now parents don’t have to worry about their thirteen-year-old daughters picking up death-causing drugs while buying bubble gum and the latest Teen Beat at local drug stores.” Similar sentiments from the Washington Times concluded that “the liberal support of young teens having wide access to post-sex contraception is part of the slow, but steady unraveling of moral code in this country.” (Another columnist for the Times published a piece supporting the use of Plan B.)

Other groups angered by Sebelius’s ruling called the decision a setback for science. Susan Wood, a Washington Post columnist and former FDA assistant commissioner for women’s health, called the decision a “betrayal” of Obama’s pledge to uphold scientific integrity and that “no other over-the-counter medication has the FDA ever required extra data for a particular age group.”

On Thursday, President Obama released a statement supporting Seibelius’s decision. He called on his role as a father and said that although he did not play a role in the overruling, he thought “most parents” would feel as he did.

The FDA’s commission on the contraceptive 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 disease. Seibelius based her decision on her doubt that the pill was safe for girls as young as 11 years old, and that the data submitted “do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.”

Plan B, also known as the “morning after” pill, has been on the market since its FDA approval in 1999 and has never been far from controversy. It became available without a prescription to those 18 and older in 2006, and to 17 year olds in 2009 after a federal court’s recommendation. Its generic version, Next Choice, also came onto the market in 2006. Other controversy around the pill rose as pharmacists began to refuse to fill prescriptions for it and other forms of birth control.

Check out some of the other discussions on the topic:

This is the Gender Report’s Week in Review, a weekly post that highlights some of the major stories related to gender issues this week. Some of these stories may have already appeared in our News Feed or in the week’s Gender Checks. We’ll at times include a longer analysis of stories as well as bring attention to stories that may have slipped through the cracks of the week’s news cycle.


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