Oh, this is rich: The Family Research Council and Concerned Women for America are suing the FDA over the agency's approval of Plan B emergency contraception for over-the-counter sale. Their complaint? The FDA's decision was politically motivated.
"It's very clearly caught up in political dynamics and I would go so far as to say there is electoral politics involved here," said [FRC's Charmaine] Yoest.
Indeed! I share Mrs. Yoest's assessment. In fact, women's rights advocates have been pursuing a lawsuit over the politicization of Plan B since January 2005. They've subpoenaed White House officials, and depositions in the case have already revealed a lot about conservative politicians' meddling in the FDA's decision-making process:
As far back as 2003, then-FDA commissioner Mark McClellan agreed to an unprecedented meeting with a White House domestic policy adviser to discuss the Plan B application. And Dr. Janet Woodcock (who also warned that Plan B would create teen sex cults) came right out and said Plan B shouldn't be sold over-the-counter to teens -- not because of the science but "to appease the administration's constituents."
Those constituents are folks like the FRC and CWA. You'd think they would be thrilled by political interference at the FDA. After all, medical research says emergency contraception is safe for women of all ages. Sadly for Yoest and her ilk, science isn't equally supportive of the claim that EC access leads to the formation of teen sex cults.
[The conservative groups'] lawsuit charges that the FDA had no authority to approve the same drug and labeling for simultaneous prescription-only and over-the-counter distribution and that the FDA cannot treat the drug differently based on the age of the buyer because "FDA lacks the authority to enforce Plan B's age limitations."
Here's another point on which I agree with the conservative groups. The FDA's decision to assign Plan B special "dual label" status -- over-the-counter for adults and behind-the-counter for teenagers -- was totally ridiculous. Thousands of pages of research said it was safe for women of all ages. And an independent advisory committee voted 27-1 to allow sale of Plan B over-the-counter with no age restriction. The conservative groups are correct that younger women can still access Plan B without a prescription (they're free to e-mail me; I'd happily purchase the drug for any woman under 18). Which makes it all the more apparent that labeling Plan B differently for sale to teens was not a practical or science-based decision, but a purely political one.
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Watch Charmaine on a previous MSNBC appearance with Brian Williams debate Plan B Friday the Family Research Council, filed a federal lawsuit against the Food and Drug Administration (FDA) to overturn the FDA's approval of the "Plan B" morning-after... Read More
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Ah yes, and if there's one thing the Religious Not-Right-At-All can't tolerate, it's the idea that a girl or woman can have a fallback method of contraception. Condom break? Diaphragm not in? Forget the pill? Plan B is a backstop that safely prevents unplanned and unwanted pregnancies.
Oooooooo, it makes these types so mad! We're supposed to burn in hell, not have a safe and effective method in which to rely.
"Politicize," my big saggy ass...
I think the problem here is that these days a science-based decision IS a political decision.
hahahahaha. wow. just wow.
I love it! Yet another example of the right wing's internal inconsistency. Usually, they hate federal agency control over industries, but here they're begging for it. This lawsuit (aside from the specific drug they're attacking) could have been filed by Ralph Nader himself!
On a serious note - the pleadings cite a recent scholarly article saying that Plan B's effectiveness is much lower than previously thought. Can anyone here comment on that? Here's the quote:
"More credible and more recent data put the efficacy above 23% (at a 95% level of
confidence) but suggest that the “the published efficacy figures calculated from currently
available data on this regimen—on average, approximately 80%—may overstate actual efficacy,
possibly quite substantially.� Elizabeth G. Raymond, M.D., M.P.H., James Trussell, Ph.D., &
Chelsea B. Polis, Population Effect of Increased Access to Emergency Contraceptive Pills: A
Systematic Review, 109 OBSTETRICS & GYNECOLOGY 181, 187 (American College of
Obstetricians and Gynecologists 2007)."
nausicaa,
I haven't read the study (because I don't have an ACOG membership and can't see the full text), but I do know that James Trussell (one of the authors) is incredibly well-respected and has done a lot of research on EC.
If anyone has a full-text PDF, I'd love to see it.
I agree with Quinn. Global warming science is seen as "political" right now. Has anyone seen the movie Jesus Camp? It's a documentary about evangelical kids who are homeschooled and taught EVERYTHING from a bible-based anti-science perspective. My favorite "scary movie."
I took admin law two years ago, so Law Fairy or LegallyBlondeez might be able to add more... but anyway, an agency has limited statutory grounds upon which to make a decision. For libertarians/federalists, this is a good thing - we're all for limited government interference and especially dislike the idea of giving a lot of lawmaking power to unelected, unaccountable officials.
Nevertheless, the agency receives Chevron deference if there is an issue of expertise: the courts consider the agency to be knowledgeable about the subject area and will defer to their judgment on how to weigh the evidence in front of them. (The agency is required to read all evidence, but can assign each piece nearly any weight it so chooses.) This is the problematic part for those who dislike the Plan B ruling.
I consider myself to be libertarian/conservative and have often pointed out that power goes both ways. The real problem is that the FDA shouldn't be restricting drugs so much as giving a seal of approval (maybe like Good Housekeeping). It is usually within the province of states to regulate medicine, and accountable state lawmakers are the ones who should be making this decision.
I didn't take admin, but did take legislation and federal courts . . . from a legal perspective, the FDA gets a very high amount of deference unless the plaintiff can show that the agency was acting outside the scope of its authorizing statute. It's entirely possible that letting politics enter the process of drug approval could be illegal, since the FDA is supposed to be evaluating the safety and quality of drugs (though I haven't looked up their mandate lately).
Wouldn't it be funny if FRC and CWA won their suit, only to find themselves shut out of the next round of contraceptive/reproductive drug approvals BY THEIR OWN PRECEDENT? I'm hoping for some major egg on their faces from this. We shall see.
I could be wrong, but if the decision is remotely based in science, it can be upheld, even if also influenced by politics. I think the correct result is often to remand to the agency and require that they go over all of the evidence (and, if notice-and-comment rulemaking, all of the applicable public comments). Often, as a practical matter, the agency will find its preferred result somewhere in the evidence.
I took a class on medical technology (i.e. drug approval). I think that the FDA has fairly broad latitude to approve drugs on prescription/non-prescription basis: the question is whether they can discriminate based on age.
There are a whole slew of admin law issues raised in the complaint -- you can find it on the FRC's website. They range from statutory interpretation issues (ie Chevron deference), to the sufficiency of the evidence to support the agency action under the APA, APA procedural rights (ie whether a rulemaking had to be conducted), and how the agency interprets its own regulations. The weakest claim, IMO, is the "political influence" one -- it should probably go away on a motion to dismiss. They try to argue that the fact that the Senate held up Eshenback's confirmation as FDA head until the FDA approved Plan B was improper political influence. Preposterous.
Without actually reading the complaint, I'd guess that the whole thing is pretty flimsy. Unless the FDA should have gone through rulemaking (and I have no idea as I avoided admin law like the plague in law school) and didn't, the FDA will get pretty broad latitude on the statutory interpretation and sufficiency under APA, and the political allegations as nausicaa described them are pretty hilarious.
The conservative groups are correct that younger women can still access Plan B without a prescription (they're free to e-mail me; I'd happily purchase the drug for any woman under 18).
I love you, Ann.
"On a serious note - the pleadings cite a recent scholarly article saying that Plan B's effectiveness is much lower than previously thought. Can anyone here comment on that?"
nausicaa:
this is PURE speculation and i didn't read the review, however i have an idea about why this might be. it used to be that ec was only meant to be effective within 72 hours after unprotected sex to prevent pregnancy and then that expanded to 120 hours. however, the efficacy drops after 72 hours -- and i believe it's a significant drop. so it's possible that because of this the overall efficacy rate is ON AVERAGE much lower than previously thought.
but as i said, that's just speculation...
Veex/Nausicaa:
Plan B's effectiveness is difficult to measure. After any incidence of unprotected sex, a woman has an 8% (on the average) chance of getting pregnant.
Imagine 100 women have unprotected sex and all take Plan B within 24 hours of intercourse. Imagine that five of them get pregnant. What is Plan B's effectiveness? 95%? 37%?
Imagine now (and this is the likely case) that, among women aged 18-25, the likelihood of getting pregnant after one incident of unprotected sex is 12% (given younger ages correlate with increased fertility). You still have your 100 women who take Plan B, five of whom get pregnant, but all of them are under the age of 25. What's the effectiveness? 56% (i.e. 7 out of 12 pregnancies prevented)? or 95% (five of 100 women got pregnant)?
Oenophile - I'm not sure I understand. Your examples seems straight forward. If average pregnancy rate without EC is 8% and only 5% get pregnant with EC, then it seems clear that the reduction in pregnancy rate is 37.5% (a decrease from 8 women to 5 women = 5/8 = 62%, if my math is right?) I don't think the confusion is a matter of math here, but rather on whether the method is as effective in real life as it is in the lab.
Barbie says Math is Hard! (Sorry, couldn't resist.)
It's a documentary about evangelical kids who are homeschooled and taught EVERYTHING from a bible-based anti-science perspective.
Over here, that was me. Took me YEARS to catch up on evolution when I got to college. The sad thing is that most parents don't realize what's in the textbooks - I know my parents just bought them because they were "good Christian textbooks" not because they didn't have evolution in them.
My "favorite" part, looking back, was the history book that claimed that smallpox was God's judgment on the Native Americans. I don't know who writes that drek, but they need a CAT scan, and fast!
Nausicaa: well, you're correct, it is straightforward. There is some debate, though, about how to properly measure the reduction in pregnancies. When you get into real-life issues, do you go with the standard 8% or do you estimate the fertility of the population who takes the drug? What about people who used secondary birth control as well (i.e. a sponge, diaphram, IUD, or gel)?
I can see how there's a lot of room to manipulate the numbers, although the calculation of effectiveness would be %age of pregnancies that would have otherwise occurred that did not.
Dear Feministing,
Plan B safe?
Except for the occasional death..
Anyway, if you must use an honorific, let's not use "Mrs."
That would be "Dr." Yoest, if you please.
Thank you,
Jack
Your Business Blogger
My "favorite" part, looking back, was the history book that claimed that smallpox was God's judgment on the Native Americans.
That's horrible! I'm part Native American, so yuck! But, it fits right in with that 'manifest destiny crap.'
Daniella,
I'm slightly proud of the fact that, even as an impressionable little girl who had been taught to believe her textbooks, that stuff made my stomach turn even then.
/snark/
Mind you, it was always presented in the most gentle of terms - the Native Americans were not really dying horribly, so much as just being sort of "weeded out" slightly for the Puritans to have room to settle. And it was only the really BAD Indians - the good ones lived and came to the first Thanksgiving feast, which of course was a manifestation of God's pleasure and not a result of charity on the part of the nasty Indians.
It was actually a very sensitive portrayal, in retrospect.
/end snark/
It probably goes without saying that Columbus' "treatment" of the natives didn't receive any attention in these books. Sigh.
Fuck you, Jack, if you think it's caused deaths.
And on a lighter note, all I know is that I've used Plan B, it worked, and that's all that matters. Boo hoo to the idiot christians who made this a political decision in the first place by making such an issue over making it over-the-counter and CAUSING abortions.
Oenophile - Ah, now I see what you mean. But I can only assume that the researchers adjusted for age?
I think the big problem with Plan B in the real world is that women still aren't educated enough to realize when they're at risk of pregnancy. Another problem might be that Plan B delays ovulation, sometimes by quite a bit. (The one time I took it successfully, my cycle was 2-3 weeks longer.) So maybe women are taking Plan B and then assuming they're protected for the rest of the month, then getting pregnant?
EJ, I'm proud of you for living through it, too. :>
It's so funny how Native Americans are 'part' of Thanksgiving feast and then they just disappear in American history (until the AIM that is). I remember doing all this pilgrim and 'indian' stuff for Thanksgiving in (public) elementary school, but they never mentioned smallpox, the trail of tears, reservations, that fact Native Americans couldn't vote until after women, etc. Funny that you got more info at home, even if it was skewed.
Daniella, I'm not sure which is worse: No information or information that condones it. We did learn about the Trail of Tears, but as I recall it was couched in terms that made it seem like the best of a bad situation for the Native Americans.
The Bush team and its useful idiots will be politicizing
science and opposing any expression of freedom-personal, political or otherwise- even as the rising sea waters from the melted ice caps threaten to carry them off to whatever demented paradise they dream awaits them. Hell, these assholes couldn't tolerate NASA scientists speculating about some of the ramifications of the Big Bang theory.
What, the universe began evolving billions of years ago? Next these devil secularists will be saying unmarried women can have sex without being devoured by Satan. Sigh
I am so sick of the Religious Right getting into politics... I really just want to tell them to burn in the hell they are so sure women like us are going to....
It always amuses me how overly hypocritical people who make arguments solely on their morals can be. If something is deemed scientifically and medically safe, then it is up to the person who uses it if it is wrong or not. I never understood why those who try to force their morals on me were so concerned with my "salvation." Grr…
Yeah, they're right, the FDA does lack the limitations to enforce the prescribing information on Plan B. Prescribing information that was put in place only to placate the conservative opponents to the drug. So what should we do about this problem? Oh! Make it available over the counter for all women, right? I'm wrong aren't I? Stupid logic, getting my hopes up.
And Ann's right, any under 18 girl that knows me could ask me to buy Plan B for her and I'd be happy to do it. I'd even pay for it myself. I'm thinking about buying some to send to college with my younger brother this fall just in case he knows anyone who might need the drug. And when my sister stops thinking of boys as gross jerks (hopefully never, but she is only 11) I'll buy some for her too. Not saying she'll ever need it, but I want her to have unrestricted access to it just in case.
I agree with K-ten that it's up to the person taking the drug if it's morally right or not. Some people would say it wasn't morally right to put me on birth control at 14. Some other people would also say it's not morally right to allow a young girl to suffer intense, debilitating cramps for 4 days a month (yay for primary dysmennorhea). My family and I happen to be in the second category. Seasonale is my best friend.