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Blog Roundup: FDA policy shift on Plan B

April 24th, 2009

On Wednesday, the FDA announced that the emergency contraceptive Plan B — also known as the “morning-after” pill and, more technically, levonorgestrel — will be made available without a prescription to women at least 17 years old, in compliance with a federal court order issued a month ago, as Sarah Rubenstein reported on the WSJ Health Blog:

Back in 2006, the FDA gave the go-ahead to over-the-counter sale of the emergency contraceptive, known as Plan B, for women 18 and older after three years of delays in which there were angry protests by pro-choice groups and alleged back-room arm-twisting by conservatives close to the Bush White House. But the FDA said then the drug would remain prescription-only for those 17 and younger.

Last month, a federal judge ordered the FDA to allow sales of Plan B to women 17 years and older without a prescription, and slammed several current and former FDA officials for their handling of the matter, accusing them of using “political considerations, delays and implausible justifications” to hold up the nonprescription sales of the drug.

Christine P. Bump provided further details on the FDA Law Blog:

Plan B has been available by prescription since 1999. On August 24, 2006, FDA approved non-prescription use of Plan B for women 18 years and older. Women 17 years and younger, however, still needed a prescription to obtain the drug. FDA described its August 2006 decision as a conclusion reached through an “extensive process” of obtaining expert advice and public comment. The Agency stated that the non-prescription use of Plan B presented novel issues, and that FDA was committed to “a careful and rigorous scientific process,” although an advisory panel convened by FDA had recommended by a vote of 23-4 that Plan B be available over-the-counter without any age restrictions. Note that the effect of both the District Court’s decision and FDA’s notice would still require a prescription for girls under the age of 17, although the District Court remanded the matter back to FDA for the Agency to “reconsider its decisions regarding the Plan B switch to OTC use.”

Naturally there has been a great deal of discussion about this development and the overarching issue around the blogosphere since the FDA’s decision not to appeal the federal court order. On Donklephant, Alan Stewart Carl noted:

The change isn’t huge. The previous age for over-the-counter purchase was 18. But do not doubt that the Obama administration will not have the problems with this rule that the Bush administration had. Many abortion opponents consider the morning-after-pill to be no different than an abortion and Bush was sympathetic to those worries. Obama, on the other hand, is decidedly liberal on the abortion issue.

Of course, much of the debate comes down to when you think life begins… I think, for most people, the issue is not so clear cut. My views on abortion are complex and too complicated to effectively describe in a blog post. But I will say that I support Plan B contraceptive. Mistakes happen, either out of foolish moments of passion or failure of other contraceptive devices. Plan B allows for otherwise responsible people to remain responsible and not have a child they don’t want or can’t care for. It’s not perfect. But doing nothing and waiting to see if pregnancy results creates even greater problems and deeper moral dilemmas. It’s easy to draw bright lines, but it’s not always what’s best for a responsible society.

At NC Policy Watch’s Progressive Pulse blog, Sean Kosofsky wrote:

The old arbitrarily drawn line was 18 even though there is no research or evidence showing why only adults should have access to the drug known as “Plan B.” Emergency contraception is a superdose of “the pill” and prevents a pregnancy, but cannot end a pregnancy.

… tens of thousands of young women may now be able to prevent unintended pregnancies more easily should they face an unintended sexual encounter, be the victim of rape, or if their first choice of contraception failed. NARAL Pro-Choice North Carolina has worked for years to ensure that every pharmacy in NC stock Plan B and that all emergency rooms have it available for rape victims. This move by the FDA is terrific progress.

Sharon L. Camp applauded the FDA’s policy shift, and also noted that more is still needed:

The FDA’s announcement was as welcome as it was expected. It followed a U.S. District Court decision in March 2009 finding that the FDA had bowed to political pressure from the Bush administration in its 2006 decision to limit access to emergency contraception without prescription to women aged 18 and older. The court ordered the FDA to expand over-the-counter access to 17-year-olds within 30 days. It further ordered the reconsideration of all age restrictions, which never had any scientific basis and were ideologically driven.

But just changing the policy is not enough. Continued efforts to raise public awareness about emergency contraception are essential and should include debunking myths about the method. For example, many women and men still do not know that emergency contraception exists or are confused about how the method works… Importantly, and claims by birth control opponents notwithstanding, emergency contraception will not in any way disrupt an established pregnancy. And it is not to be confused with mifepristone, sometimes called RU-486, a drug used to terminate a pregnancy that is only available and administered at clinics or doctor’s offices. Much still remains to be done to help women and their partners improve their contraceptive use overall.

Comparing the choice of words in the Washington Post article about the news to her own wording, Melissa McEwan commented:

I said: “women 17 and older.” The WaPo said: “women as young as 17.” That’s an interesting difference in perspective, isn’t it? Veritable chasms of meaning can be built into such small linguistic variation!

It’s also fascinating that the WaPo notes that 17-year-old women are minors, even though that’s largely moot, given that the age of consent is 17 or younger in all but 8 states. Only… where young women are allowed to have sex but not allowed to decide for themselves what to do if a pregnancy results is the fact that Plan B is being made available to “minors” even relevant. In a sane world, dictated by logic, and in which women are smart enough to make their own decisions about both sex and its potential consequences, it’s not worth mentioning.

Near the beginning of the month, Dr. Russell Turk, an OBGYN in Connecticut, responded to the aforementioned March 23 federal court ruling and agreed with the judge that even an age minimum of 17 was illogical: (hat tip to Elisabeth Garber-Paul at RH Reality Check)

The data is overwhelming: The morning-after pill is safe, with zero long-term side effects. Hundreds of my patients have used it effectively with no or only minimal (short-term nausea, abdominal discomfort) side effects. Many of my patients who ask for it were using condoms that failed. Few if any were using the morning-after pill as a replacement for birth control.

Now that 17 year olds have been cleared to buy the drug without a prescription, the battle will shift to whether younger teenagers will be allowed to do the same… opponents are already gearing up for a fight, instilling fear in parents about all the horrible things that will happen if 13- or 14-year-old girls get their hands on these pills. First, I want to point out that children can buy pain relievers, cold medicines and even household cleaners with far more serious side effects and potential dangers than this drug. More to the point, widespread availability of the morning-after pill has the potential to prevent unplanned pregnancy and abortion — both of which pose far greater risk and hardship to teen girls.

The irony is that once a girl is pregnant, she’s legally considered an “emancipated minor” — which means she can make medical decisions of a much more serious nature without adult supervision. And yet we can’t trust her to make a decision that will keep her from getting pregnant?

At Women’s Health, Karla Reed noted and detailed another facet of this issue:

Emotional and moral issues aside, the focus is blurred concerning the physical adverse effects and unseen dangers that the approval of unprescribed access to those under 18 (without parental consent) could harbor.

Active opponents of the new approval have raised the following concerns regarding unmonitored use of Plan B in the under-18 age group:
  • Plan B may be misused as routine emergency contraception in lieu of regular birth control method and may impact long term health in this population.
  • Concern has been raised that those in this age group may make dosing errors resulting in both overdosing and underdosing mistakes and consequences.
  • Use in this age group may result in failure to seek proper medical care, advice or follow up as needed.

For more information about the use, effects, and risks of Plan B (which Reed outlined in her article), please see the FDA Drug Information Page for Plan B.

What do you think about this development? Should Plan B be so accessible for 17-year-olds? Should it be available over-the-counter regardless of age?

Join the discussion in the comment area below.

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2 Responses to “Blog Roundup: FDA policy shift on Plan B”

  1. Anonymous Says:

    Mom Blogs – Blogs for Moms…

  2. niki Says:

    wow . . . it always amazes me what people will say . . . and as one not very good at watching what i say in response

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