Tuesday, February 15, 2011

The Emergency Contraceptive Pill (ECP), Still Restricted After All These Years

"Was I really raped if my skull wasn't fractured in the attack?" "Will I be allowed to set foot inside the ED if there's even the slightest chance that my mere pregnant presence could perturb an employee?"

When these are legitimate questions you have to ask yourself if you're a woman of reproductive age in today's America, it's likely you won't have much time and energy left over to ponder the nonsensical restrictions on the sale of ECPs, like Plan B One-Step, and the FDA's ongoing contempt of court.

So here's an update on the latest developments:

Teva, the manufacturer of the emergency contraceptive Plan B, announced that they filed an over-the-counter application for Plan B One-Step with the Food and Drug Administration this week. The application requests that the agency make the emergency contraceptive available without a prescription for women of all ages.

This development comes on the heels of the Center for Reproductive Rights filing a motion for contempt against the FDA for failing to follow a 2009 federal court order regarding Plan B. On March 23, 2009, Judge Edward Korman of the U.S. District Court for the Eastern District of New York found that the FDA's prior decision to limit over-the-counter access to Plan B to women over 16 was based on politics rather than science. He ordered the agency to reconsider that decision.


The Center originally filed a Citizen Petition with the FDA in 2001 on behalf of over 70 medical and public health organizations, asking the agency to grant emergency contraception over-the-counter status. When the FDA refused to rule on the petition, the Center filed a lawsuit in 2005 in federal court. In 2009, the court ruled that the agency had acted in "bad faith and in response to political pressure," not science, when it repeatedly and unreasonably delayed making a decision on Plan B, and that the agency had departed in significant ways from its normal procedures. Soon after the ruling, the FDA acknowledged its obligation to reconsider making Plan B available over-the-counter to all ages and said that it intended to make a final decision on the drug's availability to women under the age of 17. But this year, the agency admitted that it does not plan to reconsider the Citizen Petition, as the court ordered. As a result, the Center argues that the FDA has continued the same pattern of steady and repeated inaction seen during the previous administration.

And while we await the FDA's decision with trembling anticipation, just a reminder:

Plan B One-Step is available.

i-Pill is available.

Nextime is available.

Next Choice is available.

(More on Plan B One-Step, i-Pill/Nextime, and Next Choice.)

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At 2:03 PM, Blogger liz said...

Gah!!!! This is so frustrating!!!!

And a question, what's an "ED"?

At 7:06 PM, Blogger ema said...

Heh, just a fancy name for the ER (Emergency Department). {ducks in case any ER docs read this}


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