This Man Is A Pawn

On Friday, the food and drug commissioner, Lester M. Crawford, announced that he would indefinitely postpone a ruling on Plan B, the morning-after pill made by Barr Laboratories.

The law states that the Food and Drug Administration was required to reach a decision on Plan B eight months ago, last January.

But instead we've gotten nothing by delays.

The following is from the New York Times today.

Dr. Crawford said Friday that the F.D.A. would seek public comments over the next 60 days on whether it had the authority to approve Barr's application and whether it could enforce any regulation that would stop girls younger than 17 from buying the pill freely.

Here is my public comment Lester:

This pill, which does not abort a pregnancy, but simply stops one from happening, like the birth control pill does, should be available over the counter.  In fact, it should have been last January.

UPDATE:  Jason Chervokas writes in his excellent comment to this post:

What exactly is the compelling states interest in making sure that the fertilized eggs of 16 year old girls implant on uterine walls?

No sex without pregnancy, seems to be the goal.

Sure does Jason.

Comments

[Jason Chervokas]

Amen, Fred.

This whole episode has nothing to do with anything but the Christianization of the federal government by a group of religious radicals. Remember in May of 2004 the FDA refused to allow Plan B sales OTC, despite a 23 to 4 ruling in favor of the drug by the agency's scientific review panel. The agency almost never dismisses the review panel's findings, and certainly never when the finding is so strongly in favor of one position over another.

What exactly is the compelling states interest in making sure that the fertilized eggs of 16 year old girls implant on uterine walls? No sex without pregnancy, seems to be the goal. And these people seem to view children as the misbegotten punishment due to those poor godless unfortunates who have sex out of wedlock. I guess that's what they call "compassionate conservatism." Remember that crock of shit marketing line?

The assault on science in this administration is Taliban-esque, from stem cell research, to plan B, to "intelligent design." The assault in private choices is even more Taliban-esque.

[Mike]

It is more important to have a good plan A. A 100% plan A is abstinence. However, to get a good plan A, you have to see the doctor anyway, unless you are willing to accept barriers or spermicides with effectiveness of no more than 97%.

PlanB is not a very good plan at 89% effectiveness. I believe the FDA is prudent in not making PlanB available over the counter simply because making it more available than effective contraceptives is likely to make it plan A for many.

[Brandon]

Mike, do you believe that preaching abstinence is effective?

[Mike]

No, I don't believe preaching on someone else's blog is very effective.

[Jim L]

I must be out of it, but I can't imagine people thinking they would use the 'Day After Pill' as birth control.

I truly think it is for cases where someone makes a mistake, is forced upon, has a problem with their birth control (a tear), or things are not planned well, i.e. in the heat of the moment.

[Jason Chervokas]

Mike, Why is it the federal government's business whether or not a woman takes a hormone pill after having unprotected sex as a means of preventing pregnancy?

Why require a prescription when none is required for other forms of contraception like condoms?

Plan B-style contraception doesn't represent a public health danger. Certainly that was the finding of the FDAs own scientific review panel which voted overwhelmingly to allow OTC sales. Hormone therapy of this type has been used since the 1960s to prevent pregnancies. It has no negative side effects beyond nausea in some cases. It has no impact on fetuses if taken accidentally during pregnancy. It's been widely commercialized since the 1970s and is available in 80 countries, in many of them w/o a prescription requirement.

Plan B is certainly a little less effective than prophylactic contraception (at 89% efficacy it's about as effective as a cervical cap at 91%, and about 10% less effective than the most effective pre-sex hormonal contraception like the pill), but the notion is that this is for use as a secondary, not primary form of contraception. Certainly women interested in having sex but not getting pregnant would be likely to chose more effective contraception, using Plan B only for its intended use as an secondary contraceptive.

Because Plan B has to be taken w/in 72 hours, a woman interested in using it now would have to make sure she had a prescription in advance--unlikely if she is using other forms of contraception and feels she doesn't need an emergency solution. Or she would have to be able to get an MD to write a prescription w/in 72 hours--difficult in some places where doctors appointments are hard to come by because schedules are packed. The decision to not allow OTC sales of Plan B was made for the sole purpose of making use of the drug unlikely.

Forget the abstinence line. It's silly. That's like telling gay people not to be gay. Yeah abstinence as a form of birth control is 100% effective to the pill's 99%. But for the majority of Americans, people who are interested in having sex but often not interested in having children, it's meaningless. Often I get the sense that the abstinence line is not being promoted as a matter of public health, but as a backhand moral message--"unless you're married and trying to have children sex is bad." As a matter of avoiding unwanted pregnancies (and unwanted abortions) public health officials don't need to talk to people who are willing to abstain from sex. They need to reach people who are having sex with information and solutions. I, for one, happen to like sex and would like to have it as often as possible, but I have no interest in having any more children. The more, safe, easily available birth control options I have, the better.

When my daughter begins having sex--I say "when" because of course it is an inevitability and something that I have no moral opposition to--I hope she will be much older and emotionally prepared. Seeing that she is prepared is my job as a parent, not the government's. In the end it will be her decision how to avoid an unwanted pregnancy. I'm certain that I will not be present at the final moment of decision. I hope and believe that she and I will be able to discuss all the relevant issues and that I and my wife can help her make good decisions. But the nature of those conversations and those decisions are my family's business, not the federal goverment's. In the absence of compelling public health reasons not to add OTC emergency contraception to the list of choices, the only remaining reasons to discourage this choice by requiring a prescription are moral ones.

[Dan Jacome]

Kudos to Jason for advocating strong family values!

[Mike]

If PlanB is available OTC, it will be the least effective of all of OTC contraceptives. I believe the state has a complelling public health obligation to ensure the public is informed of the ineffectivenss of PlanB. One way to accomplish this is to require a doctor visit. Another way is to restrict OTC sales to minors under a certain age. An age by which it is assumed their education equips them to understand their choices and the implication of 11% failure rate.

[Brandon]

Mike,

Of course it’s the least effective. It is taken after having sex. All it does is stop ovulation. Ideally people would take precautions before having sex. However this does not always happen. The idea that people will use Plan B as their primary source of birth control seems very unlikely, as you mentioned it is not the most effective form of birth control. A doctor’s visit is not required for the consumer to be aware of the effectiveness. This information could just as easily be disclosed on the box. Besides as Jason pointed out by the time they are able to see a doctor and fill the prescription it may be to late anyway. Your argument seems to be that if Plan B was available OTC people MIGHT use Plan B as a primary source of birth control, therefore they shouldn’t have the option. Aside from the fact that your scenario is very unlikely, since Plan B has been shown to be safe the decision should be in the hands of the individual rather than the state.

[Jason Chervokas]

Mike,

Cure rates don't seem to be a major factor in the FDA's consideration regarding other OTC rememdies. Micatin has an efficacy rate of around 64% in treating athlete's foot. A topical 5% benzoyl peroxide solution has about a 60% efficacy rate in treating acne.

Pharamcists are perfectly capable of providing information about failure rates to women coming in to buy Plan B OTC. And a it is fair to presume that no one would be coming in to make that purchase other than subsequent to unprotected sex or prophylactic failure. The logic that an 89% success rate requires a doctor's involvement as a matter of public health doesn't hold up to close scrutiny, nor is it the position being advanced by the Bush administration.

[Mike]

I've decided ineffective birth control is really in our best interest. So I'm OK with it being available OTC to everyone. I'm going to focus on better athelete's foot efficacy.

[charles odell]

Dear Sir or Lady,
Thanks for the comments. I
agree with you.