Emergency Contraception/Plan B

In the wake of last week’s decision on Plan B One-Step, you may be wondering how an administration can be taken to task when it does something so extreme. Over 5,000 people already have joined our letter telling the President and Secretary Sebelius that science should speak for itself. And then, there’s legal action. On Tuesday, the Center for Reproductive Rights (CRR) announced that it is reopening its 2005 lawsuit against the FDA to make emergency contraception available over the counter to all women. CRR also announced that it would add Secretary Sebelius as a defendant. If the Administration still doesn’t come to its senses after hearing from thousands of Americans, an order from a judge could change things.

So what is this lawsuit all about? Before there was Plan B One-Step, the one-pill form of emergency contraception, there was the original Plan B, which requires taking two pills over a twelve hour period (and remains on the market today, but behind the counter). In 2001, CRR filed a Citizen Petition to make Plan B available without a prescription to all women regardless of their age. In 2003, Plan B’s manufacturer applied to have the medication available without a prescription, but the application was denied in 2004. Plan B’s manufacturer submitted a revised application, but the FDA failed to meet its own deadline to review that application in January 2005. Read more »

We were disappointed by Health and Human Services (HHS) Secretary Kathleen Sebelius’ decision to overrule the evidence-based decision reached by the Food and Drug Administration (FDA) to remove the age restriction on emergency contraception. So it didn’t really come as a surprise when President Obama voiced his support for Sebelius’ decision (watch it here).

But that doesn’t mean it didn’t hurt. Even worse was how Obama defended Sebelius’ decision – speaking as a father about his daughters. Emily Douglas from The Nation and Rebecca Traister from Salon nailed it when they wrote about Obama’s paternalism.

If President Obama and Secretary Sebelius are concerned about 11 and 12 year old girls accessing emergency contraception without fully understanding how to use it, perhaps they should consider investing in comprehensive sex education programs. Not making emergency contraception readily available, unfortunately, doesn’t mean that young girls won’t need it, it just means that when they do, they will face significant hurdles in obtaining it. And unfortunately that means, these girls may face an even bigger challenge – unintended pregnancy. Read more »

The reaction to recent decision by Department of Health and Human Services (HHS) Secretary Kathleen Sebelius that overruled the evidence-based decision reached by the Food and Drug Administration (FDA) on removing the age restriction on Plan B One Step, a form of emergency contraception, has largely centered around young women and how their access to emergency contraception will continue to be hindered.

We’ve already written about how we think the science should have been allowed to speak for itself.

But we also want to underscore that young women are just one group of women who are affected by this decision. In reality, all women continue to be affected by the age restriction, as emergency contraception will continue to be kept “behind the counter” at pharmacies, so pharmacists can verify the age of those purchasing it, instead of on the shelves alongside other over the counter medicines (and likely far from the bubblegum). Read more »

Today, despite all evidence showing that Plan B One-Step should be available over-the-counter to all women no matter their age, the Secretary of HHS, Kathleen Sebelius, told the FDA that it could not make Plan B One-Step available without a prescription for women under 17. This isn’t just speculation about what happened behind closed doors – this is straight from the horse’s mouth in the form of a letter from Secretary Sebelius to FDA Commissioner Margaret Hamburg, M.D. Determinations of drug safety should be left to scientists, not political appointees. President Obama has said this himself – and ironically the White House Office of Science and Technology Policy is currently working to implement a policy to ensure the integrity of scientific work across the government. And so, it appears that these principles don’t apply when the women’s health is at issue.

Secretary Sebelius’ letter says she decided to intervene because there isn’t not enough research showing that girls of the youngest reproductive age, those as young as 11, could understand when the medication is needed and how to use it. But according to an article in The Washington Post earlier this week, Plan B One-Step’s manufacturer provided the FDA two studies as part of its petition to remove the age restriction. One study showed that between 72 and 96% of girls ages 12 to 17 understood the packaging. The second study showed that girls ages 11 to 16 could use the product properly and safely. The research is there. It was reviewed by FDA scientists. The FDA Commissioner herself stated that the scientists found the research conclusive that Plan B One-Step should be available without prescription for women under 17. The final score should be Science-1, Politics-0. Instead it’s the other way around. Read more »