1. Health
Dawn Stacey M.Ed, LMHC

The FDA is Overruled: Teens are Denied Emergency Contraception

By December 7, 2011

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So, I'm not entirely sure what is going on in Washington these days. First, we have been dealing with President Obama's consideration to expand the refusal clause which would allow faith-based employers to have the power to make decisions about contraceptives for their employees and block affordable access to them. Now today, Secretary Kathleen Sebelius of the U.S. Department of Health and Human Services (HHS) opposed the request to allow Plan B One-Step (the morning-after pill) to be sold on drugstore shelves, without a prescription, and in doing so, overruled the FDA's decision Wednesday that emergency contraceptives should be freely sold over the counter.

Back in February, Teva Pharmaceutical Industries, manufacturer of Plan B One-Step asked the FDA to allow for nonprescription status of this emergency contraceptive. The company cited results of two studies -- one involving 335 girls (ages 12-17) that revealed 72-96% of the girls understood the proposed package label well enough to use the product safely and effectively on their own; and the other study (consisting of about 300 girls, ages 11-16) showed that these participants could use Plan B One-Step both properly and safely. And, the FDA agreed with Teva; FDA commissioner Dr. Margaret Hamburg wrote in a statement that she feels there is adequate and well-supported data that shows Plan B One-Step is safe and effective for nonprescription use for all females of childbearing years and that all the studies and experts agreed that young women would benefit from having easy access to Plan B One-Step. In fact, the original FDA Advisory committee that recommended approval for Plan B One-Step was nearly unanimous in its recommendation and did not find reason (even then) to not allow it to be sold over-the-counter at any age.

Yet, none of this seemed to make any difference to Ms. Sebelius, who wrote in a statement, "Today's action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional... Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed the FDA to issue a complete response letter denying the supplemental new drug application by Teva Women's Health, Inc." Under the law, Ms. Sebelius has the authority to overrule the FDA, but no health secretary has ever done so before... gee, I didn't realize that she knows so much that she would have the audacity to claim superiority and go against the careful and scientific recommendations of the FDA.

What a blow to women everywhere, if you ask me. In order to buy the morning-after pill, you need to show verification of your age to a pharmacist because the drug is kept behind the pharmacy counter. To be most effective, Plan B One-Step should be taken as soon as possible (after unprotected sex or birth control failure). So what does one do if you need this drug, it is after-hours, and the local pharmacies are closed? If Plan B One-Step (or the generic Next Choice) could be obtained directly off the shelf (like condoms, the sponge and spermicides), ANY female could have access to this and hopefully avert an unintended pregnancy. Even as it now stands, if the pharmacy is closed, it doesn't matter that a 17 or 18 year old doesn't need a prescription - she still can't get the drug until the morning!

The fact of the matter - the morning-after pill has been steeped in controversy (and politics) over the years. Even back in 2009 when the FDA lowered the age requirement to allow 17-year-olds to purchase it without a prescription, the agency only did so because of a court order. A federal court judge ordered the FDA to allow 17-year-olds to purchase the morning-after pill and further asked the agency to consider whether this drug should be available OTC to women of all ages. The court even ruled that the FDA's initial decision to restrict access was based on "political and ideological reasons" -- not science.†In 2005, after the FDA decided to delay OTC access of Plan B, even after its scientific advisory board approved it, Assistant FDA Commissioner for Women's Health, Dr. Susan Wood, resigned in protest declaring that "the scientific staff [at the FDA] were shut out of this decision."

It truly amazes me that even in the present day, with all the medical evidence that emergency contraception is a safe and reliable way to prevent an unwanted pregnancy, †it is still such a controversial issue. If our goal is to reduce abortion and teen pregnancy, then it only makes sense to allow teens easier access to a viable way to achieve this goal. Over the years, Plan B One-Step has proven to be a highly influential agent helping to drastically lower the number of unintended pregnancies as well as the number of abortions. It seems pretty backwards to me that there is an effective product available that can make a huge difference in preventing teen pregnancy, yet because of ideology and politics, the population who may most desperately need such a product has to jump through hoops to attain it.

The greater powers at be should listen to people who are truly in-touch with the adolescent community. Sarah Brown of the National Campaign to Prevent Teen and Unplanned Pregnancy explains that "there is simply no evidence to suggest that making contraception available to teens encourages them to begin having sex, have sex at younger ages or have more sexual partners. Moreover, most of us would rather have sexually active teens use contraception than become pregnant." It is disgraceful and embarrassing that the US has the highest rates of teenage pregnancy in the developed world - I guess as the alarming statistics about teen pregnancy in the US continue to be a reality, we can now, in part, say a big thank you to Ms. Kathleen Sebelius.

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January 31, 2012 at 12:44 pm
(1) Arlene says:

Here’s an updated to the whole emergency contraception for teens debate: Yesterday (January 30th) the FDA Pediatric Advisory Committee hosted a safety review meeting that discussed Plan B emergency contraception. It is standard practice for the FDA to accept data from research on older age groups and apply it to younger groups. This is done for nearly every drug and there is no reason to hold Plan B emergency contraception to a different standard, especially since evidence of Planís B safety is well established!

Yesterday, committee members unanimously voted to recommend that FDA continue routine monitoring of Plan B emergency contraception for women under 18 years old and suggested no new safety-related changes needed to be added to instructions for use. There was significant agreement that Plan B One-Step is safe for pediatric populations. Several committee members expressed confidence that Plan B emergency contraception is safe for use without a prescription by women of all ages.

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