Ronald Bailey | April 24, 2006
The Center for Reproductive Rights is suing the FDA for stalling the approval of the emergency contraceptive Plan B for over-the-counter availability. This week lawyers representing the Center get to question various current and former FDA officials about how decisions were made about Plan B. Newsday is reporting that one FDA memo detailed the concerns of Actiing FDA Deputy Commissioner for Operations, Janet Woodcock:
Simon Heller, one of the attorneys, plans to quiz Woodcock about a March 23, 2004, staff memo suggesting she was concerned Plan B might lead to teenage promiscuity.
The FDA is only supposed to consider the safety and efficacy of drugs.
In the memo released by the FDA during the discovery process, Dr. Curtis Rosebraugh, an agency medical officer, wrote: "As an example, she stated that we could not anticipate, or prevent extreme promiscuous behaviors such as the medication taking on an 'urban legend' status that would lead adolescents to form sex-based cults centered around the use of Plan B."
Look for the FDA to conclude soon that condoms and the pill must be banned because they too may encourage sexual activity.
Whole Newsday article here.
Reason's take on the controversy here and here.
Disclosure: I have donated less than $100 to support the Center for Reproductive Rights.
Help Reason celebrate its next 40 years. Donate Now!
Try Reason's award-winning print edition today! Your first issue is FREE if you are not completely satisfied.
Years ago when I first heard about Lysenkoism, I was baffled
that a society could exist in which politicians ordered scientists
what to think.
Now I live in such a society.
I just wanted to say:
You're all invited to join my sex cult once Plan B is made OTC.
P.S. That's not an invitation for rape or even a guarantee that said sex cult will guarantee sex for anyone involved.
Newsday is reporting that one FDA memo detailed the concerns
of Actiing FDA Deputy Commissioner for Operations, Janet
Woodcock
The memo purporting to detail Woodcock's concerns was written by
Dr. Rosebraugh, not Woodcock, so keep in mind this case is based on
hearsay.
This post is even better if you imagine Beavis and Butthead are
reading it along with you.
Janet Who? heh heh. heh heh.
Teenager sex, of course, is much more likely than adult sex to be of the unsafe variety. So, if the drug actually does encourage teen sex cults, its users would experience heightened risk of STDs. Thus, its encouragement of teen promiscuity is a safety issue.
"As an example, she stated that we could not anticipate, or
prevent extreme promiscuous behaviors such as the medication taking
on an 'urban legend' status that would lead adolescents to form
sex-based cults centered around the use of Plan B."
Dear FDA Commission, I am writing to you regarding the approval of
"Plan B" contraceptives....
Look for the FDA to conclude soon that condoms and the pill
must be banned because they too may encourage sexual
activity.
Condoms are not food or drugs, so they do not fall within the FDA's
jurisdiction. Also, the pill is no easier to get than Plan B, as
both are available only with a prescription.
Condoms are not food or drugs, so they do not fall within
the FDA's jurisdiction.
I'm pretty sure that many devices with a medical purpose
do fall under the FDA's jurisdiction.
You're all invited to join my sex cult once Plan B is made
OTC... P.P.S. I just figured we could all get together and play
cards or something.
Will there at least be a cot on the premises?
Because I'll need a place to take a nap, as is my habit.
But I don't know if condoms fall in the category of non-food, non-medicine devices that fall under FDA jurisdiction.
For instance, if a drug caused people to commit suicide, would the FDA have to approve it because the resulting deaths are not directly caused by the drug?
Not unless you ate it, alhough I suppose the flavoring is
probaby FDA approved.
"As an example, she stated that we could not anticipate, or
prevent extreme promiscuous behaviors such as the medication taking
on an 'urban legend' status that would lead adolescents to form
sex-based cults centered around the use of Plan B."
All kidding aside, how the fuck do they come up with these
hypotheticals?
"...thus its encouragement of teen promiscuity *is* a safety
issue.
= by avocado of the devil
Er, Counselor...point of order... what precedes your *thus* does
not establish your assertion. You are taking as de facto the case
that "making contraceptives available encourages promiscuity"
(which is debatable itself) - then declare it is a safety issue,
through making yet other false assumptions.
By 'promiscuity' we presume you'd mean lots of sex *with many
partners* - as opposed to just lots of sex with one or a few
partners, no?
So, how does the ability to protect yourself from an unwanted
preganancy differ materially from condoms, diaphragm, the pill,
etc, in that it will increase the average number of partners a
'teen' has?
Because the availability of these other contraceptives hasnt
demonstrated over time any increase in the # of partners women
have.
In fact, most 'teen pregnancies' (and/or teens who have sex with a
wide variety of partners at a young age) come from lack of
education and lack of availibility of this stuff.
The whole STD line of argument falls flat, unless you can
demonstrate some reason that female teenage behavior on average
would change substantially due to some characteristic of this
specific contraceptive.
Weren't these same arguments trotted out 30 years ago with the
introduction of 'the pill'? Did teenagers manage to bypass the
barriers to acquisition en masse and turn into sex crazy disease
bags? Not as far as I can tell.
The biggest problem with sex tends to be the people who dont want
other people having it.
Which goes to show that many "conservative" politicians have no idea what morality is.
I am the only one who thought the phrase "sex-based cult" extremely odd? It sounds like the FDA is more worried about the religious practices of teenagers than it is about their health and safety. If teenagers only formed clubs based on sex and not cults, would it be as bad?
The biggest problem with sex tends to be the people who dont
want other people having it.
As is often the case with these leaked memos, this thing seems to
be being blown out of proportion. That said, Mr. Gilmore is 110%
correct, and were his statement not true, we'd get rid of a lot of
this silliness.
Earl, want some of your daughter's panties? They come in four
flavours.
Banana, peach, mint, and, of course, cherry.
Teenagers these days. They won't even appreciate the sex cults. Once you make it to where you can last longer than 4-5 minutes, that's when the sex cults start being more pleasant for everyone involved.
crimethink,
Condoms are not food or drugs, so they do not fall within the
FDA's jurisdiction.
You do realize that the FDA is currently drafting a labelling
regime for condoms? Currently the FDA only requires a label about
the allergenicity of the latex.
Further note that the female condom had to be cleared for use by
the FDA before it could be sold in the U.S.
Needless to say, the FDA has its nose in all sorts of things, many
of them having nothing to do with foods or drugs.
Yes, condoms definitely count as medical devices if they make
disease prevention claims.
FDA has long taken into account knock-on effects (no advantage,
scrum-down here) in ascertaining a drug's or device's effect on
health, and therefore its "safety". A common excuse for having many
drugs & devices be prescription-only is that the conditions
they're for are serious enough that people should be made to see
doctors about them.
thoreau,
Condoms are regulated by the FDA. Indeed, they have their
regulation of them broken down into different classes of
condoms.
Robert,
As I recall, the FDA assigned to the condom industry the task of
determining procedures, etc. to create a safe enough condom.
I am the only one who thought the phrase "sex-based cult"
extremely odd?
Sex + Cult = Fun
As an example, she stated that we could not anticipate, or
prevent extreme promiscuous behaviors such as the medication taking
on an 'urban legend' status that would lead adolescents to form
sex-based cults centered around the use of Plan B."
And the problem is?
Carpet-humping man already has a sex-based cult centered around the
use of Plan A.
I guess we could all have sex while listening to The Cult...although that might be a little surreal. Probably up there on the weirdness scale with the time I made it with Eraserhead on on the background.
crimethink,
Also, the pill is no easier to get than Plan B, as both are
available only with a prescription.
One wonders why either should require a perscription? Do you own
your body or does the government or your church?
This just breaking: the raunch davidian compound has been stormed for stockpiling illegal contraceptives. The FDA has ordered its agents to surround the cult members and bring them into custody. Stay tuned with us for updates on this dire situation. . .
I find the phrase "taking on an 'urban legend' status" deeply
weird. I can't even figure out what it's supposed to mean.
Approving Plan B might lead Plan B to cease to exist in reality and
become apocryphal?
The more-semantically-coherent meaning is substantively even
weirder: We should worry about Plan B because we're worried about
the kinds of teenaged sex cults which *we concede don't really
exist.*
"Urban legend" as a premise within one's own argument is just
bizarre-- it's usually a label you'd use to discredit an empirical
premise of the *opposing* argument. We'd expect Plan B *supporters*
to be the ones who called sex cults "urban legends," right?
I guess we could all have sex while listening to The
Cult...although that might be a little surreal. Probably up there
on the weirdness scale with the time I made it with Eraserhead on
on the background.
I'm still privately amazed by my one "session" with Metallica's
"And Justice For All" as the background music.
I was pretty much my own one-person sex cult in
high-school.
More in keeping with the topic of this thread, I was pretty much my
own one-person completely imaginary sex cult in high
school.
I guess we could all have sex while listening to The
Cult...Probably up there on the weirdness scale with the time I
made it with Eraserhead on on the background.
The only time I can remember music being on in the background, it
was the Last of the Mohicans soundtrack. Unfortunately, I
don't know whether what I was doing at the time counted as sex.
Oh, like we didn't see this pne coming...Ron Bailey, in addition to his other crimes against inhumanity, is a first class shill for the reproductive rights lobby. Has this man no shame!
I'm still privately amazed by my one "session" with
Metallica's "And Justice For All" as the background
music.
Oh...yeah...I dated this girl who was REALLY into Metallica for
awhile, I got used to that noise, stopped seeming weird after a
bit.
Every story around here suggests great new band names! Teenage Sex Cult? Imaginary Sex Cult?
I guess we could all have sex while listening to The
Cult...although that might be a little surreal. Probably up there
on the weirdness scale with the time I made it with Eraserhead on
on the background.
(Gasp!) Eraserhead?!?
If anything would be a mood-killer, I would think it would be
that movie. The last thing I wanted to do while
and after watching that movie was have sex.
Non of us fuck, see? Sex is boring, ugly, hippy
shit..
How unconventional is your marriage, Lydon? how much did you like
Sid?
Damn... I'd figured that at least THIS topic would draw some women posters, but no...
Site comments/questions:
Media Inquiries and Reprint Permissions:
(310) 367-6109
Editorial & Production Offices:
3415 S. Sepulveda Blvd.
Suite 400
Los Angeles, CA 90034
(310) 391-2245