Critical Condition - October 26, 2005

Plan B: what you should know (and are being prevented from doing) about the morning-after pill.

By Kate Steadman, UC Santa Cruz

I’ve heard a lot about Plan B. Do I need a prescription to get it or not? I’m confused.

You’re not the only one. So is the Food Drug Administration (FDA). Plan B – also known as the morning-after pill – is a form of emergency contraception used to prevent unplanned pregnancy. It’s basically a birth control pill of a special dosage that you can take up to 72 hours after unprotected sex to reduce the risk of pregnancy. Sounds straightforward, right? Not according to the FDA. The FDA rejected one application to sell Plan B over the counter, and has delayed making a decision on a second application even though it was due last January. For now, whether you need a prescription or not depends on where you live. So far only eight states (including Alaska, California, Hawaii, Maine, New Mexico, New Hampshire, and Washington) have passed legislation making Plan B available over the counter. In the other 42 states, you need a prescription from your doctor.

So what’s the hold up? Is it dangerous?

Actually, emergency contraception similar to Plan B has been used throughout the world for decades. It’s proven to be safe – even for young girls – and it’s effective, reducing the risk of pregnancy by up to 89%. So why is this pill causing such a stir in the nation’s capitol? In a word, politics.

I hear there’s a lot of that in Washington these days.

When new pharmaceuticals or medical devices appear before the FDA, they are reviewed by an advisory committee of experts in the field (for Plan B, the committee would consist of doctors and researchers with expertise in reproductive health). After reviewing the evidence, as well as hearing testimony from other experts and organizations, the committee makes a recommendation on whether or not the FDA should approve the new product. For the majority of proposals, if the panel deems the new pharmaceutical or device safe, the FDA follows with its stamp of approval. The FDA already approved Plan B for prescription use in the 1990s, but its manufacturer, Barr Laboratories, submitted a second application to make the medicine available over the counter. Women’s advocacy groups highly praised this development, particularly because many pharmacies don’t carry Plan B. Some hospitals don’t offer it to rape victims, and worse, a survey of Catholic hospitals found that only 28% offered emergency contraception.

So what went wrong with Plan B? Did they have a bad Plan A?

That’s the cause of the uproar. The committee recommended, 23-4, to approve Plan B for over the counter sale. Despite this overwhelmingly positive recommendation, the FDA rejected the application. One member of the panel, David Hagar (of ‘prayer is the cure for PMS’ fame) raised objections, citing increased risky behavior in young teens if Plan B were available over the counter.

That seems like a reasonable concern. Young teens are pretty crazy – have you ever seen Ryan Cabrera’s hair?

It would be a reasonable concern except for the mountain of evidence to the contrary. Numerous studies have shown that even giving young teens Plan B – not just the knowledge that they could buy it – has no impact on their behavior. Despite this evidence, and the panel’s recommendation for approval, the FDA rejected Barr’s application in May 2004.

But there’s more to the story. Barr Laboratories redrafted its proposal to make Plan B available over the counter only for women 16 and over (girls younger than 16 would still need a prescription from a doctor). But this dual status – both over the counter and prescription availability – has never been done in the U.S. As Ayelish McGarvey writes in The Nation,“ This proposed ‘behind-the-counter’ arrangement raises several serious concerns. Never before has the FDA approved a drug for this type of distribution, and it is unclear whether the agency even has the statutory and regulatory authority to do so.” The FDA agreed to make a decision by January 2005 in the face of difficulties surrounding the dispensing of Plan B. But the hurdles appear to be about more than regulation, as the agency still hasn’t issued a decision. To be sure, the FDA is under strong pressure from Democratic leaders in the Senate, including Hillary Clinton (D-NY) and Patty Murray (D-WA), who put a hold on Lester Crawford’s nomination for FDA Commissioner until he promised a decision by September 2005. No decision came, and Crawford resigned on September 23 after only two months on the job.

Amy Allina, of the non-profit advocacy group the National Women’s Health Network, believes there are serious consequences to the FDA’s inaction: “The repeated delays that FDA has imposed on the Plan B OTC application and its refusal to act on the recommendations of its medical staff and expert advisors have called the agency’s scientific integrity into question.  The FDA’s decision to put politics before science in this case has undermined its reputation not only in the U.S. but also around the world.”

So I still can’t buy it over the counter? What do I do if I don’t live or go to college in one of those eight states?

The good news about being a college student is that University Health Centers are trying to make it easy to get Plan B, despite all the problems in Washington. If you live in a state where you need a prescription, like Kansas, call your doctor and ask about his or her protocol for prescribing Plan B. According to Cathy Thrasher, a pharmacist at the University of Kansas Student Health Center, when students sign in they can request a prescription for Plan B to expedite the process. If you’re lucky enough to live in a state that doesn’t require a prescription, you only need to talk to the pharmacist. In California, pharmacists “prescribe” Plan B – you can’t just buy it off the shelf. Diane Lamotte, RPh, from the University of California, Santa Cruz, was involved in the original test project in 2000 to determine if pharmacists could safely prescribe Plan B. Then-Governor Gray Davis approved legislation making it legal for pharmacists to prescribe emergency contraception only nine months after the project began. Efforts for similar legislation are underway in other states.

That was fun – I’m off to the pharmacy!

Not so fast – not all pharmacies, even in states where you can get Plan B without a prescription, carry it. According to company policy, no Wal-Mart pharmacies sell Plan B.

While we wait around for the FDA to issue its final decision, it’s worthwhile to learn the current laws in your state and figure out which pharmacies in your area carry Plan B. You can go to http://www.not-2-late.com, or call the national Emergency Contraception Hotline, operated by the Reproductive Health Technologies Project, at 1-888-NOT-2-LATE. Many gynecologists are giving women prescriptions for emergency contraception at their annual physical – it’s worth it to ask your doctor to do so.

The American Academy of Family Physicians estimates that “widespread use of emergency contraception could reduce unintended pregnancies in the United States by one half. . . . Based on this projection, the number of elective terminations also could be reduced by one half, potentially resulting in 700,000 fewer abortions.” Apparently the FDA is deaf to the testimonies of experts, advocacy groups, and its own advisory panel. Plan B is not an abortifacient, and has a lower risk of side effects and complications than an abortion. The bottom line is that Plan B is safe and effective.

 
Kate Steadman, a native of the reddest of red states, Kansas, graduated from the University of California, Santa Cruz in June with a B.A. in sociology and pre-med requirements fulfilled. Kate has worked at the National Women’s Health Network in Washington, D.C. and the Venice Family Clinic, the largest free clinic in the nation, in Los Angeles. She has an unhealthy fascination with health care and will be moving to Washington , D.C. to work in health policy. When she’s not reading about health issues, she enjoys staring at her computer, listening to NPR, and knitting.

If you have a question or suggestion for Kate regarding Critical Condition, contact her at ksteadman@gmail.com.

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