Womens Health

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

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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?

Me too. 

After all, every scientific finding out there supports OTC sales.

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?

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 the fact is that 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. Now that Teva has filed its application, however, advocates fear the FDA will take a piecemeal approach, rather than ending all  restrictions once and for all. 

The problem is that Teva’s application will only apply to Plan B which means that every other type of emergency contraception (there are four kinds) will have to file separate applications to be eligible for over-the-counter, all-ages status.

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.