Over-the-Counter Emergency Contraception? The FDA Saga Continues


Editor’s note: Portions of this article were edited at 9:15 pm, Thursday February 10th, 2011 to cut out repetitive paragraphs.

Are you tired of waiting for the FDA to get its head out of you-know-where and finally approve over-the-counter sales of emergency contraception without restrictions?

Me too. 

After all, every scientific finding out there supports OTC sales without age restrictions.

Did you think that this would have been done already, given our President promised in his very inaugural speech to restore “scientific integrity” to policy in the United States?  After 8 long years of hocus pocus?

Me too.

After all, we’re ostensibly all on board with the plan to reduce unintended pregnancies and the need for abortion, right?  (Yes, I know, not all of us, but the ones that voted for this Administration.)

Then why are we still waiting for the FDA to approve this method?  And why are politics still involved in women’s health care under an ostensibly pro-choice, pro-science administration also ostensibly committed to reducing unintended pregnancies??

Why are we still fighting the government for our rights to access effective methods of birth control?

Two years ago, a court found that the FDA’s decision to limit access to EC was based on politics rather than science and ordered the agency to reconsider its decision.

According to the Center for Reproductive Rights (CRR), in March 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 access to Plan B was based on politics rather than science and ordered the agency to reconsider that decision.  The FDA ignored this court order and continues to do so. On November 16, 2010, the Center asked the court to hold the agency in contempt for ignoring the court’s ruling and to order the FDA to make a decision within a specified amount of time.  The FDA acknowledged the court order, but subsequently took the position that the best way for it to comply with the order is to wait for a new application from the drug manufacturer.

Today, Teva, the manufacturer of one form of emergency contraceptive known as Plan B filed an application with the FDA requesting that Plan B be made available over-the-counter without a prescription for women of all ages.  That sounds very nice but since Teva’s application will only apply to Plan B, advocates fear the FDA will take a piecemeal approach, requiring that companies file a separate application for every other type of emergency contraception (there are four kinds) to be eligible for over-the-counter, all-ages status, rather than ending all  restrictions on all forms of emergency contraception once and for all as the science indicates should be done.

CRR has been fighting this fight for ten years

Work started on this case in 2001 and CRR officially sued the FDA in 2005 for failing to grant over-the-counter status to EC against the advice of its scientific experts and in violation of its own procedures and regulations. But that was during the Bush Administration. The FDA later agreed to make EC available without a prescription, but only to women 18 and over and only behind the pharmacy counter. The Center continued to pursue its case because there are no medical grounds for denying young women access to emergency contraception.

In a statement today, CRR called out the FDA–again–for balking:

While the Center supports all actions to make emergency contraception more readily available to women, we want to make it clear to the FDA that Teva’s application doesn’t mean that they’re off the hook. While we support any action to increase access to EC, let us be clear: Teva’s application does not excuse the FDA of its responsibility to women and the law.

This is a medical and public health no-brainer.

Each year, about six million pregnancies occur in the United States. About half occur among women who did not plan on having a baby, otherwise known as unintended pregnancies.  Half the time, according to Princeton University, it is because birth control failed, meaning that the contraceptive itself didn’t work or that a woman and her partner made a mistake when they were using it. The other half of the time, the couple wasn’t using any method of birth control.

Using emergency contraceptive pills (also known as “morning after pills” or “day after pills”) in the first few days after sex reduces the risk of getting pregnant by at least 75%, giving a woman a second chance to prevent pregnancy if her birth control failed, she had sex without using contraception, or she was forced to have sex.

Making emergency contraception available and informing women about it can help them prevent an unintended pregnancy and reduce the need for abortion.

Like I said: No-brainer.

Who or what is the FDA afraid of?

The Center wants your help to make them very afraid…. of you.

Go to their petition page to send a message to the FDA.

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  • jackie627

    Emergency contraception is over the counter in the United States for anyone over 17 years old.  You just need to go to any pharmacy counter and ask for it.  It is rare that ID is checked or even asked for.  It is expensive but accessible.  There is Plan B One Step and another called Next Choice which is two tablets.  You can actually just take both Next Choice tablets together and it is less expensive than Plan B One Step.  Most pharmacies have these products available and for employees it is the same as selling a newspaper. There is no judgment and in most cases they will only ask if you have any questions about its use.  If you go to the pharmacy and someone gives you a hard time, go somewhere else and call in a complaint about the original pharmacy.  Contacting the corporate office is a big deal for a chain pharmacy!!

  • ack

    The argument is that there is no medical or scientific basis for the age restriction. It’s completely arbitrary, and based on politicians denial that teens have sex as well as an erroneous belief that EC causes abortion.

  • squirrely-girl

    … doesn’t mean behind the counter. :/

     

    And your assessment regarding the ease by which women can obtain EC is a tad optimistic. Please don’t assume that all women have an easy time obtaining EC just because you do (?). There are numerous reports of women being turned away or asked inappropriate questions, particularly in rural areas.

  • ookamiamaterasu

    Having to ask a pharmacist to give you the medicine, despite not needing a perscription, means it’s not over-the-counter. If it was readily available on a shelf in the pharmacy wit no age restriction like, say, cold medicine is, then it would be OTC.