Posts tagged EC OTC

Change You Can Believe In (Vol. III, No. 12): Emergency Contraception.

From the New York Times (December 7, 2011). Boldface mine, for the parts that feel like getting kicked right in the stomach.

WASHINGTON — For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season.

The contraceptive pill, called Plan B One-Step, has been available without a prescription to women 17 and older, but those 16 and younger have needed a prescription — and they still will because of the decision by the health secretary, Kathleen Sebelius. If taken soon after unprotected sex, the pill halves the chances of a pregnancy.

Although Ms. Sebelius had the legal authority to overrule the F.D.A., no health secretary had ever publicly done so, an F.D.A. spokeswoman said… .

— Gardiner Harris, Plan to Widen Availability of Morning-After Pill is Rejected, New York Times (Dec. 7, 2011)

Until now.

Ms. Sebelius’s decision on an emotional issue that touches on parental involvement in birth control for teenage children is likely to have powerful political reverberations. Scientists and politicians have been at odds for years over whether to make Plan B available over the counter. The Bush administration at first rejected over-the-counter availability for women of any age, but ultimately allowed it for women 18 and older. After a federal court order, the Obama administration lowered the age to 17 in 2009.

With Ms. Sebelius’s decision on Wednesday, the Obama administration is taking a more socially conservative stance on Plan B, one closer to that of the Bush administration than to many of its own liberal supporters … .

For Dr. [Margaret] Hamburg [head of the Food and Drug Administration], the studies and experts all agreed that young women would benefit from having easy access to the pill and did not need the intervention of a health care provider. The agency’s scientists, she wrote, determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.

… Dr. Susan Wood, a former F.D.A. assistant commissioner who resigned in 2005 to protest the Bush administration’s handling of Plan B, said that there were many drugs available over the counter that had not been studied in pre-adolescents and that were far more dangerous to them.

Acetaminophen can be fatal, but it’s available to everyone, Dr. Wood noted. So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?

… The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have endorsed over-the-counter access to emergency contraception. Plan B was approved in 1999 as a prescription-only product, and it initially had few sales. In 2003, advocates filed an application for over-the-counter sales.

An expert advisory committee recommended approval, and scientists within the Food and Drug Administration unanimously supported that recommendation. Their rationale was simple: women can decide on their own when they need to take it, the drug is effective and its risks are minimal — particularly compared with pregnancy. But in a highly unusual move, top agency officials rejected the application because, some said later, they feared being fired if they approved it.

The agency delayed reconsideration for years despite promises by top Bush administration officials to do so. Then in 2006, the Bush administration allowed over-the-counter sales to women 18 and older but required a prescription for those 17 and younger. In 2009, the F.D.A. lowered the easy-access age limit by a year after a federal judge ruled that its decision had been driven by politics and not science.

— Gardiner Harris, Plan to Widen Availability of Morning-After Pill is Rejected, New York Times (Dec. 7, 2011)

Progressive Pro-Choice Peace President Barack Hussein Obama would like the Washington Post to know that he didn’t do it. He didn’t do it, but he dug it.

President Obama said Thursday that he supports his administration’s decision to block unrestricted sale of the morning-after pill to people younger than 17, a move that dismayed women’s advocates when it was announced by Health and Human Services Secretary Kathleen Sebelius.

Sebelius said Wednesday that she had overruled the Food and Drug Administration, which had decided to make the contraceptive available to people of all ages directly off drugstore and supermarket shelves, without a prescription.

Obama said he did not get involved in the decision to require a prescription for girls 16 and under before it was announced, leaving it up to Sebelius.

But, he said: I will say this. As the father of two daughters, I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.

And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old, going to a drug store, should be able to, alongside bubble gum or batteries, purchase a powerful drug to stop a pregnancy, Obama said. I think most parents would probably feel the same way.

— Rob Stein and Anne E. Kornblut, Obama defends administration’s refusal to relax Plan B restrictions, The Washington Post (Dec. 8, 2011).

Especially parents who are trying to win a political election. I wonder if they bothered to ask an 11-year-old girl, who is afraid of becoming pregnant, how she feels about it?

About 10 percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, Sebelius said.

— Rob Stein and Anne E. Kornblut, Obama defends administration’s refusal to relax Plan B restrictions, The Washington Post (Dec. 8, 2011).

Therefore, the state should ensure that the youngest girls of reproductive age are forced to get pregnant.

Back in the New York Times:

Norman Ornstein, a resident scholar at the American Enterprise Institute, said the Obama administration may be trying to assuage Catholic bishops and others angered in recent weeks by a decision requiring that health insurance programs created under the new health reform law offer contraceptives for free.

I think they’re trying to create some political balance, Mr. Ornstein said.

— Gardiner Harris, Plan to Widen Availability of Morning-After Pill is Rejected, New York Times (Dec. 7, 2011)

Yes, a balance. Marvel as President Obama, liberal voters and the Catholic Bishops defy gravity in a spectacular balancing act! Right on top of a terrified 12 year old girl’s body.

This decision is inexcusable. And what makes it even worse is having to watch to the newsmedia calmly discussing the political calculations that went into it, as if what really mattered here had nothing to do with the lives affected by this decision, with the girls who have to live in fear of an unwanted pregnancy because their access to basic medical treatments has been regimented and sacrificed for the sake of a Democratic politician’s political prospects — as if what was really worth discussing was whether that palavering creep and the rest of his administration will be able to effectively exploit this regulatory backstab to increase their chances at holding onto political power for another four years. There are no English words for just how contemptible this shameful display is.

See also:

EC OTC in OZ

Update: fixed typos and relocated the Extended Entry into the main text.

Here’s some more good news on the Emergency Contraception front: while the FDA process has advanced to the point where EC will probably be available over-the-counter sometime or another soon, Australia is quickly moving one step ahead of the United States: Emergency Contraception is set to become available over-the-counter in Australia tomorrow, January 1.

This isn’t to say that Australia’s EC situation is advanced over that of the United States in every respect. One major difference is that whereas the medical community in America largely supports the FDA’s move towards OTC availability, the medical community in Australia is at best nervous about the move, and in some cases directly opposed. The main issue for them, though, seems not to be the sort of religious Kulturkampf that flares around the American side of the debate. Rather, Australian doctors just seem to be more accustomed than American doctors to controlling the medical lives of their patients, and more jealous at giving up that power. For example, consider this Foucaultian bit of paternalism:

But Australian Medical Association president Bill Glasson said he was concerned that pharmacists were not legally required to record a woman’s visit.

I think that they really need to rediscuss how it is going to operate in the interest of good medical care, Dr Glasson said.

The pharmaceutical society’s national president, Jay Hooper, said many pharmacists would take it upon themselves to record each time a woman wanted the pill.

Not that American doctors don’t also sometimes engage in this tracking and scummy hectoring. At the Auburn University Student Health Center, for example, you could obtain EC—but they’d note when you got it, throw a bunch of red tape in your way, and if I recall correctly, they’d only let you have it once a semester. (The idea in both cases is for doctors to be able to lecture women that they decide are making unhealthy lifestyle choices. I am all for encouraging women to make healthy lifestyle choices, but I can’t imagine that an emergency situation to prevent a pregnancy is the appropriate time to do it, or that forcing women to listen by restricting access to EC until you’re done lecturing them is the appropriate way to go about it.) But the American medical community does not seem particularly squeamish about giving up that control if it means that women are more able to prevent unwanted pregnancies: the American Medical Association and the American College of Obstetricians and Gynecologists both lobbied for, and strongly supported, the FDA advisory panels’ decision. In Australia, however, the Australian Medical Association seems nervous and is ready to develop their own house guidelines to try to minimize the freedom it will offer women.

I don’t think, incidentally, that the attitude is a matter of misogyny, exactly. But it is directly connected to patriarchy—it’s a matter of the authoritarian sense of entitlement that modern doctors have always felt and acted out vis-a-vis their patients. The condition exists in Australia and America both, but with regard to over-the-counter pills the Australian medical community seems to have divorced itself from it less than their American counterparts. Consider: at the same time as EC becomes available over the counter for the first time in Australia, so will ibuprofen. And this has caused no small degree of consternation for the Australian Medical Association:

Also from Thursday stronger pain relief medication will be available in supermarkets, a move that has angered and confused doctors and pharmacists. Dr Glasson said the pain killer ibuprofen, contained in products including Nurofen, should only be sold under the supervision of pharmacists. It’s a dangerous move and it’s a backward step.

Patients have to look at the medical aspects of these drugs and get good advice that only the friendly pharmacist can give. Paracetamol is much kinder on the stomach.

Ibuprofen, an anti-inflammatory drug, was only available in pharmacies until the Government ratified the new regulations in October.

Products containing ibuprofen have been available in supermarkets in the US since 1984 and in Britain since 1996.

The teeming masses of Ozzies will now be able to buy Advil without a doctor’s learned advice! O tempora! O mores!

But however the doctors and pharmacists may whine, the women of Australia have every reason to celebrate. A happy New Year’s to the reproductive rights community in Australia — good show!

Signs and Portents for EC OTC

Good news this month for women’s reproductive freedom! The widespread availability of emergency contraception (EC) is one of the main breakthroughs for women’s reproductive freedom in the past 10 years. So it’s even better to see that two advisory panels of the FDA recently voted to recommend that EC be made available over-the-counter without the need for a doctor’s prescription. You need to take EC within 72 hours of unprotected sex for it to prevent an unwanted pregnancy, and it gets less effective as time goes on; waiting around for a doctor and a pharmacy are not always a viable option. And there is no possible case to be made that it fails the FDA requirements for over the counter availability. Drugs are supposed to be made available OTC when (1) it is safe to use without a doctor’s supervision, and (2) the instructions are simple enough for self-medication based on the included instructions. That EC is safe, and doesn’t need close observation from a doctor, has been made obvious by all the scientific data and by the past 30 years of experience with both off-label uses of conventional oral contraceptives, and dedicated morning-after pills like Preven and Plan B. How about the simplicity of use? Well, here I’ll defer to Connie Schultz, who investigated the matter for the Cleveland Plain Dealer:

Still, … I thought it only fair that I try to decipher them for myself. The kind folks at Planned Parenthood of Greater Cleveland gave me a sample packet. To make it as difficult as possible, I imagined being a sexually active teenager who had abstinence-only sex education.

Would I, could I, understand what I was reading?

Instruction No. 1: Take the first tablet as soon as possible within 72 hours of unprotected sex.

Instruction No. 2: Take the second tablet 12 hours after you take the first tablet.

I think we women can handle it.

This is some great news. Unfortunately, it is only a promissory note for things to come: the FDA nearly always follows the recommendations of its advisory panels, but even if it is pretty sure that it will make EC over the counter, it is entirely unclear when it will do so. The Bush Administration’s FDA has a long record of foot-dragging on this issue, and it has taken two years of untiring activism to get to this point — quite in spite of the fact that the petition obviously meets all the relevant criteria. But the most recent events are a victory to be celebrated, and the light at the end of the tunnel is now in sight.

Now, here’s a question: chemically, Emergency Contraception is indistinguishable from a large dose of conventional oral contraceptives; dedicated EC drugs were developed based on a good 30 years’ worth of doctors’ off-label recommendations for using OCs. (If a patient needed emergency contraception, the doctor would offer a prescription for OCs and suggest that the patient take several at once.) So if safety and ease-of-use arguments show that EC meets the FDA’s requirement for over the counter drugs, then a fortiori they ought to show that the good old birth-control pill meets those requirements too. So while we work towards getting the government out of women’s medical decisions for the morning-after pill, why shouldn’t we also start thinking about a campaign to get the government out of women’s medical decisions for the conventional birth-control pill too?