The 15+ age restriction on Plan B is not even a baby step in the right direction. Here's what you haven't heard.

Posted on 5.14.2013 by Lily

A new chapter is presently unfolding in the interminable 12+ year struggle to get levonorgestrel-based emergency contraception (EC), commonly known as Plan B or the morning-after pill, sold over-the-counter with no age restriction on retail shelves. The safety of EC cannot be overstated. It has been attributed to NO deaths, NO serious complications, and has NO contraindications besides a specific allergy to levonorgestrel (which nobody has, since it's just a synthetic version of hormones made naturally by your body). It could basically be the safest drug ever to be sold in places like convenience stores, gas stations, and supermarkets. I can't think of a single other OTC medication that boasts the same safety profile - and all of those are sold without age restrictions, despite many being labeled as not for pediatric use.

First, a brief timeline of events in Plan B's sordid history.

-1999: Approved as a prescription-only drug for women of all ages.

-2001-2006: Bush packed the FDA with his cronies over actual scientists, who blocked progress for years, despite their own advisory panel voting 23-4 in favor of OTC status in 2003. (Yeah. We could have been done with this circus 10 years ago.)

-2006: We started taking baby steps forward. First EC went behind-the-counter for women over 18 who could prove their age. (Despite, yet again, the FDA recommending in 2005 that the age limit be lowered to 17.) Behind-the-counter is sort of like over-the-counter in that you don't need a prescription, but it doesn't really improve access very much, because the pill could still only be sold in pharmacies and not retail establishments that sell much more dangerous drugs like aspirin, caffeine, and Tylenol. Under this status, Plan B is less accessible than cigarettes, which are also behind-the-counter, but sold everywhere from supermarkets to gas stations and not subject to pharmacy hours. And so Plan B remained inaccessible to women under 18 without a prescription, and stayed difficult to access for all women.

-2009: The behind-the-counter age restriction was lowered to 17 on U.S. District Judge Edward Korman's orders (more on him below), and a generic version (Next Choice) became available. And that's been the status quo since.

-2011: The FDA, now composed of actual scientists, was poised to allow all levonorgestrel-based emergency contraceptives to be sold OTC with no age restriction. We rejoiced! No more incremental steps forward, no more lowering the age one year at a time while the pill languished behind pharmacy counters, off-limits to women under 17, women who can't prove their age, women who got to the store after the pharmacy was closed. It was really about to happen! ...For a few hours, anyway.

Because Kathleen Sebelius, Secretary of Health and Human Services and longtime pro-choice advocate, bewilderingly betrayed us in an unprecedented move of overruling her own scientists and blocking the policy they were set to implement at long last. Why? She didn't think they had showed that the pill would be safe for 11 and 12-year-olds. Of course, she based this unprecedented and outrageous interference on her years of medical experience and many impressive scientific credentials. Just kidding! She actually had no qualifications whatsoever to make that judgment, and it was really just a political maneuver in our little American game of thrones that, once again, sacrificed women's health. (Hey, we're pretty used to it at this point. Just not from people we thought were our allies.) President Obama, who campaign-promised to return public health policy to science after the horrors of the Bush years, publicly supported her decision. Or was really the one behind it, a year before his re-election. Who knows.

And that's how nothing changed for another year and a half. It is not unreasonable to suggest that thousands upon thousands of women have gotten pregnant unintentionally since Sebelius's intervention because they couldn't access EC in a timely fashion. Roughly 50% of those pregnancies likely ended in abortion.

And that brings us to the present. Well, as of last month, when my current hero Judge Korman - who has been involved in this struggle for years - overturned Sebelius's decision and ordered that all levonorgestrel-based emergency contraceptives be sold OTC with no age restrictions within 30 days. He also told the government just what he thought of their actions in no uncertain terms: they were "arbitrary, capricious and unreasonable" as well as "politically motivated, scientifically unjustified, and contrary to agency precedent."

The government is appealing his ruling, because why admit defeat in their shameful game now? Judge Korman's order was supposed to go into effect this past Friday, though he agreed to delay it until yesterday to allow the government to file their appeal. But! What has the FDA been up to in the meantime? Well, a few weeks ago they approved a policy to lower the age for OTC access from 17 to 15, and to put the medication on pharmacy shelves rather than behind-the-counter. This is happening even if the government wins their appeal against Korman's order to remove the age restriction altogether. So even worst case scenario, we still get a net benefit, right? Another maddening incremental step in this ridiculous 12+ year process, but at least going in the right direction. Right?

That's what I thought at first, too. But actually: nope! Not really at all. In fact, I would argue that rather than benefiting anyone, least of all 15 and 16-year-olds, this pretty much just constitutes a regressive and convoluted clusterfuck of a corporate government compromise.

Here's what you need to know about the 15+ policy. Note: This information comes from the courtroom transcript (pdf) from last week's hearing between Korman and the Obama administration's lawyer Frank Amanat, as well as Korman's written opinion (also pdf) from Friday. Many of these details, as far as I know, have not been widely reported and are not commonly understood.

1. The 15+ policy was crafted by the FDA in a "sweetheart deal" with Teva. That's the corporation that makes Plan B One-Step, one of several available versions of levonorgestrel EC. Guess what that deal means, incredibly enough? Plan B One-Step will be the ONLY EC product on store shelves. Other forms of Plan B, and the generic Next Choice, will remain behind-the-counter, still only accessible to those 17 and up. More on the implications of that below.

2. This creates a muddled 3-tiered system of access to EC bound to be misunderstood and poorly executed. 15 and 16-year-olds who can prove their age can buy Plan B One-Step without a prescription, women 17+ who can prove their age can buy any levonorgestrel-based EC without a prescription, and women under 15 and anyone without proof of age still have to get a prescription. This is a recipe for total market confusion for patients, pharmacists, and cashiers, who will surely be misinformed, tell customers the wrong information and deny legal sales. (This happens already under a much more straightforward system).

3. Plan B One-Step will only be on the shelves in stores that have an on-site pharmacy. So the number of establishments that can carry it will continue to be heavily restricted. No supermarkets, no small convenience stores, nowhere else that sells basic meds.

4. The drug's packaging will include a device (driving the price up) to prompt the cashier to verify age. Much has already been said about the improbability of most 15 and 16-year-olds having a government-issued photo ID to prove their age, without which the drug will be just as inaccessible as it ever was. Birth certificates and school IDs will not be accepted. Furthermore, an enormous number of adults in this country - adults who are disproportionately black, poor, and immigrants - do not have photo IDs either, and thus will need a prescription no matter their age. As Korman admonished Amanat, "if this were a voting rights case, you would be here on behalf of the Department of Justice telling me that this was voter suppression ... The department's position is that photographic identification constitutes an impediment to their being able to vote. And those are adults who have time, and [EC] is an emergency situation."

5. It gets better! Because Teva will essentially have a monopoly on EC on pharmacy shelves, it's estimated that the price for that one pill will run about $60, and possibly higher due to the convoluted packaging requirements. By comparison, the generic Next Choice is about $35. (Already damn expensive.) So 15 and 16-year-olds who want to prevent pregnancy in an emergency situation just have to come up with $60 or more, get a government-issued photo ID they are statistically unlikely to have, find a pharmacy that has EC on the shelves, and make it within the 120-hour window in which EC can be effective. So simple and accessible! Or as Amanat put it, "Any person over the age of fifteen will soon be able to walk into any ... of the 60,000 retail establishments in the United States that has an onsite pharmacy and be able to purchase this drug without a prescription." Easy as that!

Keep in mind that EC becomes less effective the later it's taken. And remember too that anyone over 17 who comes in looking for EC when the pharmacy is closed will only have the $60+ One-Step as their option.

But hey, it's not like we have any right to crucial medications. Mr. Amanat reminded Judge Korman of this during the hearing: "There's no principle of law which says that any consumer is entitled to buy whatever product they want from whatever establishment they want [... or] at the price they want." Ahh, America, where health care is a luxury consumer item entitled only to those who can pay.

6. One other thing. Say you do go get a prescription, whether out of necessity, you'd rather your insurance paid for it, you want counseling from your provider, or whatever reason. You will not be able to get a prescription for Plan B One-Step, which will now be ONLY available on pharmacy shelves for $60+ with no insurance coverage. Now, all levonorgestrel-based ECs are essentially the same - Plan B One-Step is not any more or less effective than any other - but the one-pill regimen is simpler to understand and easier to follow. Regimens with two pills, as in Plan B and Next Choice, can be taken together as though they were one pill, and it's common practice to tell patients that when we sell it at clinics. But that's not what it says on the packaging, and pharmacists won't direct off-label use. Two-pill regimens typically instruct women to take one pill as soon as possible and the other pill 12 hours later, which can lead to forgetting the second pill and rendering the whole regimen useless. Basically, the simplest form of emergency contraception - the one most likely to be taken correctly - could now be prohibitively expensive for many people.

Awesome, huh? Every way you look at it.

And that's why this 15+ policy is bullshit, nothing more than an attempt to whitewash the government's indefensible actions and pander to a drug company. Emergency contraception will not be more accessible in any meaningful way. But Teva's pockets will be lined and the government gets to look like they threw us a bone, while we continue to be baffled and misled, paying exorbitant prices, and getting pregnant and having abortions we should never have needed.

Yesterday, a federal appeals court put Judge Korman's order to remove all age restrictions on hold until at least May 28 while the government appeals. And so we wait some more.

And every day we wait, some women can't access EC, and their lives are changed forever.