Why the Morning-After Pill Is Like a Really Popular Blog Post

Another milestone in the FDA's increasingly creative effort to delay a decision about emergency contraception:

A two-month comment period on making the "morning-after pill" Plan B available without a prescription ended yesterday, with as many as 10,000 comments apparently submitted but no indication of when or how the Food and Drug Administration will proceed with the controversial application.

Now that we're putting drug safety decisions to a nationwide vote, when can we expect a yea or a nay? In precisely the time it takes an FDA regulator to read 10,000 comments. Or not.

The agency's next step "will depend on what we see in the comments," said FDA spokeswoman Julie Zawisza. "We'll read them all and decide how to proceed."

I make the case for putting Barr's Plan B over the counter here. Reason's Ron Bailey discusses the FDA's War on Promiscuity here.

Comments

[Timothy]

Plan B nothing, all hormonal birth control should be over the counter.

[jimmy]

i would love to see Plan B avaliable over-the-counter. but there are about a million drugs that ought to be de-prescriptionized first, including antibiotics and cholesterol meds as pointed out in the pages of Reason last year. but once again, as with the supreme court nominations, abortion/choice has hijacked all discussion and made itself the only issue that anyone can talk about.

[B.P.]

I assume that 9,975 of these comments are form letters from places like Colorado Springs and Tulsa.

[smacky]

I don't get it. "Comment period"? Is that what it sounds like? Since when did scientific advancement become subject to popular (unscientific) opinion?

[mediageek]

Silly smacky.

We vote on everything now. After all, democracy proves that Clay Aiken is the best singer EVER!

[anywoman]

This should have been available YEARS AGO!! It should be as available as condoms - in little machines everywhere! Bush and his white male conservative corrupt cronies have got to go !!! This deliberate delaying is an affront to all women, young and old !! Everyone should be able to be in charge of their own reproductivity, NOT just males! And young women need this more than anyone...a mistake at their age and their whole life changes. If a young man makes a mistake (a daily if not hourly occurence if i may say so) he just walks away and his life is unaffected. Our daughters & granddaughters need this pill. We should stage a giant demonstration that follows the head of the FDA all day long until he realizes women of America won't put up with this BS!!

[scott]

As a libertarian, it is issues like this that really get me depressed. I look at an issue like this and see what seems to be the obvious- the FDA needs to go. But 99% of my fellow pro morning after pill travelers just don't get it. To them, the problem isn't the FDA, it's the people running the FDA. If only the evil Bushies were gone this inherently oppressive bueracracy will magically becomone wonderful again. They're just like the Bosnia nation building critics who suddenly fell silent once Blow Job Bill was out of office we started doing the same thing in Iraq. Most people just don't care about liberty. All they care about is getting "their" people in charge of the instruments of oppression.

[smacky]

Silly me.

heh. heh.

[David]

I can hear the "Plan B is an abortifacient" screams now. I'm always puzzled at how an omnipotent God can be foiled by a pill.

My theory is that it has always been about the sex anyway.

[SR]

"It should be as available as condoms - in little machines everywhere!"

Actually, at least in Denver, those little machines in men's rooms all seem to be filled with gum, breath mints, and temporary tatoos. I don't think I've ever seen one in real life that has condoms.

[quasibill]

Smacky,

Welcome to the wonderful world of notice and comment. It's part of the process of all regulations (as opposed to legislation). It's part of the way that they rationalized away the fact that the creation of federal agencies in the executive is delegating a legislative function to the executive, and at the same time, removing accountability from elected positions and putting it in career service positions. All of which, of course, is directly the result of the federal government getting involved in issues that it was never meant to be involved with.

[Brian]

Interesting idea B.P. If I recall 99% of the complaints to the FCC about Janet Jackson's boob were astroturf outrage from Brent Bozell's operation. Wonder if the fundies are stuffing the FDA's inbox now.

[Akira MacKenzie]

"Since when did scientific advancement become subject to popular (unscientific) opinion?"

I ask myself that every time I hear of a school district adopting "Intellegent Design" into their science ciriculum.

[TJIT]

One class of drugs that need to be prescription only are antibiotics.

If antibiotics are not used correctly the result is antibiotic resistant bacteria. These bacteria can cause problems for the general public so antibiotic misuse is an honest public health issue.

[poco]

Possible compromise: antibiotics dispensed by pharmacists.

Anywoman: BC-induced amenorrhea aside, maybe you should avail yourself of more periods.

[Timothy]

scott:

I'm right there with you, at the very least the Phase III trials need to go, and perhaps the Phase II as well. The Phase I trials are seemingly where you get all the "will this kill me?" information, and that's probably good to have, but I'm pretty sure it would happen anyway even without the FDA.

[Phil]

Part of the beauty of public comment periods are that they're, well, public, which means you can watch your fellow Americans take part in being ignored by the executive branch agencies that control their lives. Public comments on Plan B are located here; notice that it's innocuously listed on the docket as rug Approvals: Circumstances under which an Active Ingredient may be Simultaneously Marketed in both a Prescription Drug Product and an Over-the-Counter Drug Product, making it sound like a more general discussion than it is. (Something the very first commenter noticed, saying, "Is this the Morning After page??
It is not easy to find. If you would create a legible link, you will find that 8 out of 10 American women support the immediate, easy, and affordable dispensation of the morning after pill.")

I think she's probably right, based on what I read. Read and enjoy!

[SPD]

I would much rather see women have the option to take a "morning after" pill or RU-486 than get an abortion at a later time.

[Phil]

Then again:

Submitter : Miss. Susan Liska Date & Time: 10/17/2005 11:10:54
Organization : Miss. Susan Liska
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Please take all birth control pills, including morning after pills and abortion pills off the market and do not allow any more to be marketed. These are immoral and kill innocent unborn babies who have a right to live. We have to protect all life, from conception to natural death.

Submitter : Mr. David Paul Xavier Burch Date & Time: 10/17/2005 11:10:38
Organization : Mr. David Paul Xavier Burch
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Yes; because this is needed by everyone concerned!(For example, abortion-inducing/producing birth control SHOULD NOT BE LEGAL: MUCH LESS OVER THE COUNTER!

Observe the Platonic perfection of this:

Submitter : Mrs. Barbara Rine Date & Time: 10/17/2005 11:10:14
Organization : Mrs. Barbara Rine
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
No leave well enough alone. Things are complicated enough, if a drug needs to have a prescription, it needs a prescription. If a drug does not need a prescription, it does not need a prescription.

On the other hand, my hero:

Submitter : Ms. margaret bonaparte Date & Time: 10/17/2005 11:10:21
Organization : Ms. margaret bonaparte
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
The FDA should approve this product for over the counter use for anyone and stop bowing to religious interests. Any female capable of reproduction should be able to access a safe form of contraception without anyone's approval. The FDA has become a puppet of the current christian conservative administration rather than the public service agency it is supposed to be. You should be ashamed of yourselves.

[quasibill]

"The Phase I trials are seemingly where you get all the "will this kill me?" information, and that's probably good to have, but I'm pretty sure it would happen anyway even without the FDA."

I think even Phase II and IIIs would likely happen, if the FDA and associated legislation (and court crafted immunities) were to disappear. The mfrs would have plenty of incentive to ensure efficacy, especially for drugs treating dangerous conditions, and also plenty to discover dangerous contra-indications and side effects. It's even likely most of the post-market trials would continue for the same reasons.

What would happen is that the form of these trials would be streamlined to gain the desired knowledge at the lowest possible cost, and the mfrs would have an even greater incentive to not fudge the results - the loss in public confidence in such a company would make Enron look like a soft landing. Instead of being able to hide behind the FDA (and in fact capturing it to the point where it actively seeks to shield them), they would have to actively seek to buff their own image and reputation by aggressive honesty about their product.

[The Real Bill]

Gawd! After reading some of those comments, my (already low) opinion of human beings just plummeted.

I've said this before and I'll say it again:

All control freaks are evil and deserve death.

[Twba]

10,000 comments is a lot. How many of those comments are authored by Hakluyt or joe?