Obama administration overrules FDA, prohibits unrestrained access to contraception

December 7, 2011 • 5:15 pm

This is a first: in no time in history has an American Secretary of Health and Human Services overruled a recommendation of the Food and Drug Administration (FDA).  But Secretary Kathleen Sebelius just did so, overturning an FDA recommendation that all women of reproductive age be allowed access to the “Plan B” emergency contraceptive pill without a doctor’s prescription. Free access holds for women 17 and older, but the FDA recommended extended non-prescription access for younger women. (The pill, which contains progesterone, halves the chance of pregnancy if taken within three days of intercourse.)

According to the New York Times:

The pill’s maker, Teva Pharmaceuticals, had applied to make Plan B easily accessible to everyone. In a statement, the commissioner of the drug administration [i.e., the head of the FDA] Dr. Margaret A. Hamburg, wrote that all the studies and experts agreed that young women would benefit from having easy access to Plan B.

The agency’s scientists, she wrote, “determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted disease.”

”Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider,” she wrote.

After reviewing the scientists’ determination, Dr. Hamburg wrote that she agreed “that there is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.”

Sebelius nixed this:

 . . . on Wednesday morning, Ms. Sebelius sent Dr. Hamburg a note saying that she did not agree, so the agency was rejecting the application for the change.

In a statement, Ms. Sebelius said that the drug’s manufacturer had failed to study whether girls as young as 11 years old could use Plan B safely. And since about 10 percent of girls are capable of bearing children as early as 11, those girls need to be studied as well, she wrote.

“After careful consideration of the F.D.A. summary review, I have concluded that the data submitted by Teva do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age,” Ms. Sebelius wrote.

Doctors are on the FDA’s side:

“Very few medications are this simple, convenient and safe,” said Dr. Kathleen Hill-Besinque, an assistant dean at the University of Southern California School of Pharmacy. . .

The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have endorsed over-the-counter access to emergency contraception.

Make no mistake about it, Sebelius’s decision was made with the approval of President Obama, who knows the political costs of allowing young women free access to emergency contraception. In the minds of conservatives, this is a license for untrammeled sex.  And Obama’s running for President again next year.  This is not a medical decision, but a cynical and political one.

73 thoughts on “Obama administration overrules FDA, prohibits unrestrained access to contraception

  1. Make no mistake about it, Sebelius’s decision was made with the approval of President Obama, who knows the political costs of allowing young women free access to emergency contraception. In the minds of conservatives, this is a license for untrammeled sex.

    Obama sure puts a lot of effort into trying to get the votes of people who will never, ever vote for him.

    1. Agreed, why is he bending over backwards to appease the very people who will never except him as an American let alone the president anyway.

        1. Daveau.

          It makes no sense what so ever, even if his political opponents are nutjobs he is making people who are going to vote for him anyway have to hold their noses while doing so.

          1. Personally I can’t bring myself to vote for Obama again. He’s been such a disappointment, and completely ineffective in almost every way. Sure, the republicans have been unified in their opposition to Obama, but even taking that into account Obama has done nothing to earn another term (for example, no Republican forced Obama to appoint Geithner, or Summers) .. and he wont be getting my vote.

            I’ve begun to entertain the thought that perhaps it will take yet another financial crisis before we get the Democrat we really need. And what better way to precipitate another financial crisis than to let the Republicans take another turn in the White House. Sounds crazy, I know.

            But honestly, Obama behaves this way (i.e. the Sebelius decision) because he feels that it wont cost him politically. He believes that come 2012 he can turn on the charm and woo voters once again to the polls with his buttery speech making. Therefore I would like to see sensible people (and especially fellow atheists) stand together in unison and vote against Obama. Because we’re stuck in a vicious “prisoner’s dilemma” where Obama simply does not know what he believes in, and who he wants to make happy. We voters simply cannot continue to reward this kind of behavior.

          2. So what are you going to do come next November? Perhaps write in Jane Hamsher? Vote for whatever Republican whacker that gets the nomination? Maybe stay home and sulk? You and like-thinking folk make me tired. Don’t you understand what ‘democracy’ and ‘compromise’ mean? Grow up.

          3. Vote for Ralph Nader. Maybe eventually the Democratic leadership will learn their lesson.

            “Democracy” means you have to pressure politicians to support your positions. One way to pressure them is to not vote for them.

          4. And people who think “democracy” means you have to accept a two-party system makes me tired.

          5. What can I say? The Parliamentary form is superior to our system. But, in modern times, our Democracy was the first rattle out of the box. It’s far from perfect, as any prototype is. I do not know how it could be changed, practically speaking. And you don’t know either. So, if you’re fed up with the two-party system you’ll have to move to another country; I considered it but with no flair for learning other languages and little tolerance for cold weather I’m biting the bullet, so to speak, and staying right here – and trying not to whine.

          6. The dominance of two parties is not enshrined in law. It’s only inevitable if we let it be.

          7. And I do a lot more than whine. I’ve voted in every national and state and most local elections since I turned 18. I participated in the Democratic party state caucuses long enough to learn that people who want to change things are not welcome there.

            Voting for a third party or a write-in rather than Obama IS doing something.

          8. Saying that you vote for a third party candidate in all the elections, therefore you’re doing something is tantamount to saying that you’re praying for change, therefore your doing something.

            Both have an equal chance of resluting in a viable third party coming into power.

          9. I don’t vote for a third party candidate in all elections, but I do in some. In local and state elections that candidate can actually win. Jesse Ventura in Minnesota and Bernie Sanders in Vermont are two examples.

            In the presidential election, the third party candidate won’t actually win, but it will let the Democrats know what voters they’re losing.

            Remember the 1992 election, when conservative voters didn’t vote for Bush or Clinton because of Bush reneging on his “no new taxes” pledge? They were willing to let Clinton win so that their party’s leadership would learn a lesson.

            If Obama loses in 2012 because progressives didn’t vote for him, then they will have an opportunity to learn from that, just as they had an opportunity to learn from Gore’s “loss” in 2000.

          10. There is no reason to vote for Obama to “keep the GOP out of the White House” if I live in an ultra-safe GOP state, like Texas. Any progressive living in the following states can safely vote Green:

            Alabama
            Alaska
            Arkansas
            Idaho
            Kansas
            Kentucky
            Louisiana
            Mississippi
            Nebraska (3rd district)
            North Dakots
            Oklahoma
            South Carolina
            South Dakots
            Tennessee
            Texas
            Utah
            West Virginia
            Wyoming

            Such a vote is more than just a protest vote – it helps build an alternative third party for the future.

          11. So, you are unable to offer a reason why progressives in solid GOP states shouldn’t vote third party. Your revert to comparisons with funny-sounding third parties of the past in support of what principle? The idea that the United States should have two de facto political parties forever? There are no circumstances under which a third party should ever be considered? If that’s your position, why don’t you say so explicitly?

          12. The Bull Moose Party does sound silly. Yet, after all, it was the most successful, credible attempt to mount a third-party campaign. I’ve nothing against the concept and indeed wish that a third party could succeed. I simply don’t thing that that’s a practical concept at least in my lifetime.

            Better, I think, to work for a better Democratic party rather than crying in my beer.

          13. Ever since labor lost any semblance of political clout, both political parties have been owned by corporations. What leverage do you intend to apply to “make a better democratic party”? Democratic politicians are just thrilled for you to work to “make a better democratic party” – and then hire the same Goldman-Sachs assholes and the GOP once they’re in office – and call you a “retard” for expecting them to deliver on their promises. What do you suggest we do to break the Democratic party out of its current modus operandi: No matter how extreme the GOP becomes, position the Democratic candidate for president just a bit to their left in order to maximize the share of the electorate they get. Talk like a Democrat now and then, but govern like a Republican as much as possible to keep the “middle” happy. The “middle” being the more reasonable of their Wall Street donors, that is. It wins elections and gives us shitty government.

          14. Ever since labor lost any semblance of political clout

            same thing just happened in the election here in NZ.

            for the very first time, National has formed a supermajority and does not even need to bother with a coalition government.

            and yet, all their platform involves is selling NZ oil rights to foreign investors, and selling off publicly owned assets to the highest bidder, among many other things EVERY local economist here advised against doing.

            In fact, not only did every economist here advise voting FOR the Labor party, but all pundits concluded that Labor actually WON the debates on policy in the run up to the election.

            and yet, nobody listened, and now there is a National majority government.

            soon people will understand what it means to sell their country down the river; it will take about 20 years for the full impacts of this decision to be felt, but they will, and none for the better excepting the people who will take the money and run who currently populate National.

            It’s sad to see the Reagan years resurrected here, like I saw in the US.

            I thought this place had a bit more time, but it appears the insanity has reached even the remotest of places.

            *sigh*

          15. Grow up? Get a life.

            Every election season there is a debate about whether a third-party vote is a wasted vote. I tend to agree that it IS a wasted vote. But in this case WE ALREADY KNOW what kind of politician we have in Obama; so in my mind it is the vote for Obama that is the wasted vote.

            The only thing that will cause the Democrats to stick to their values is if there is a real cost if they don’t (hence the reference to the prisoner’s dilemma). Democrats should take a lesson from W. Bush.. at least he stuck to his guns all the way, and his party still loves him today. I have nothing but contempt for Obama. What has he done? “My Plate!” that’s about it.

          16. Here’s the thing guys: presidents tend to win elections by appealing to the center. We’re not the center. We’re way the hell to the left here; I’d go so far as saying that we’re probably close to 2 standard deviations away from the center.

            Obama is not going to try to court us, he’s going to try to court moderates, because that’s traditionally how presidents win elections.

            We are not going to get a candidate who appeals to us, not one who has a reasonable chance of actually winning in the general election, anyway, because we’re too small to matter.

    2. I don’t see how this is even good politics. Women preferred Obama in 2008, and the young overwhelmingly so. He seems to be doing whatever he can to make sure his voters don’t show up in 2012.

      1. Lets face it, he is not an intellectual or a savvy politician, he is just lucky his opponents are off the scale lunatics and the democrats need to focus on their next candidate if they want a truly progressive president.

        1. Depending on who you mean by “the democrats”, many of them – the ones with the money and influence – don’t want a progressive president.

        2. you know, Obama is not running unopposed, despite the fact that zero media attention is being paid to the democratic primaries.

          there is at least one progressive candidate running against him, though I really don’t know anything about him:

          http://en.wikipedia.org/wiki/Darcy_Richardson

          why wait for the next election?

          surely the current gaggle of republican contenders is SO bloody insane, that NOW is the time to actually push someone who at least has some evidence that he really is a progressive?

    3. And an equal amout of effort into getting people like me, my wife, Ed, Sandy, my father, my oldest daughter and a number of others I know to never, ever vote for him again. President Newt, here we come!

      1. You might as well be voting for a theocracy then. When you have a choice between bad and worse, worse generally isn’t the best choice. Additionally you need to be concerned with nominations to the supreme court, which last a lot longer than a four or eight year presidency.

        Americans have the shortest memory on the planet. Why don’t we elect that new guy Dahbaya Shrub he seems to be real homey?

  2. “The pill, which contains progesterone, halves the chance of pregnancy if taken with three days of intercourse.”

    That’s a heck of a prescription.

    I’m sure this is meant to be within three days of intercourse.

  3. And since about 10 percent of girls are capable of bearing children as early as 11, those girls need to be studied as well, she wrote.

    Because we all know that it’s a lot safer for an 11 year old to take a pregnancy to full term than it is to take a contraceptive.

  4. Yes, it’s a political decision. So, what will happen is:

    * If Obama is re-elected, this will be quietly passed through in about September of 2013. There being no other election for Obama to win.

    * If Romnrich is elected, this will be totally scuttled, except for those who have access to Canadian or Mexican pharmacies.

  5. Here’s what gets me: A not insignificant number of conservatives believe Obama to be a Muslim socialist Nazi from another country. They believe this despite the fact that Gitmo is still open, despite the fact that he cooked up a libertarian-fantasy Ed program called Race to the Top, despite the fact that he’s still running the American war machine at full blast, and now despite the fact that his administration has taken a shot at female reproductive autonomy. And yet this man will constantly cave to these people. He will NEVER have them on his side, so why bother? As someone who happily voted for him in ’08, I’m extremely disappointed. At this rate the Republicans don’t even have to win any elections, b/c they’re getting what they want anyway (in some cases w/o realizing it).

    1. He’s been pushing the Right things:

      Lack of Presidential Accountibility
      The War Machine
      Hamper Women’s Reproductive Choices
      Right Wing Health Care (which they now hate)
      Secret Prisons
      Torture
      Wholescale War Crimes
      Collusion with the Suppression of Free Speech
      Being in the back pocket of industry…

      1. So write in Jane Hamsher sit down and shut up. I’m sure you’ll be delighted with the Mittster.

  6. I keep waiting for the light bulb to go off among “progressives” who still support Obama, but if it hasn’t by now, I suppose it never will. Obama has supported endless anti-liberal policies because he is anti-liberal. If he had thought he could have climbed to the top in the GOP, he would have been a Republican, but the Dems were the party with black people in it, so he used that party. But its liberal traditions and achievements mean nothing to him.

    1. The light is on! (see my earlier post). But I don’t think Obama is necessarily anti-liberal as much as he is blindly and stupidly in love with the middle road, regardless of how half-way-to-hell it hurls us.

      1. To be fair, there are a metric ton of liberals who are just as in love with middle of the road BS as Obama is. Even, or it seems especially, when that middle of the road has fothing craziness on only one side.

      2. ah yes, people talk so favororably about ‘moderates’. Well this is what a ‘moderate’ does. Prodded both by the religious right and the mush brained left, moderates are the last thing we need.

    2. because he is anti-liberal

      no, that’s got nothing to do with it.

      it’s all politics.

      Read Greenwald for a detailed education on the subject of Obama’s “negotiating tactics”:

      http://politics.salon.com/2011/04/13/obama_147/singleton/

      but if you want someone who actually cares about substance over politics, you’d be best off voting for someone else in the Democratic Primaries, that’s for sure.

  7. Jerry,

    Keep up the great posts — I dare say that you are on one hell of a role yourself!

  8. This doesn’t sound like an issue that would sway undecided voters. I wonder what they were thinking.

  9. As someone above correctly pointed out, this isn’t necessarily 100% political calculation. This may just be the way Obama honestly feels about the issue. People keep scratching their heads over how he always seems to “cave” to Republicans. Maybe he’s just agreeing with them.

    1. One of my friends on another forum pointed out about a year ago that 90% of Obama’s decisions appeared to have been borrowed from Ronald Reagan.

  10. No question it’s a shitty decision but we really don’t know why they made it. It hardly seems logical to assume it’s a political decision because by this time Obama and his team have to know there’s *nothing* they could do to win over republican voters. Besides, what recourse do progressives have? Who are they going to vote for if not Obama? Romney? Gingrich? Please.

    1. We we know it was not a decision made on scientific grounds. So that does not really leave many options does it ? And none of the options it does leave reflect well on Sibelius or Obama.

  11. Seth Shulman’s book Undermining Science addressed Plan B. George Bush had used the very same argument that Sebelius is now using – that the drug has not been studied in very young girls. This is an extremely stupid argument as a 12 year old is metabolically the same as a 20 year old (in contrast a 4 month old, a 20 year old and 70 year old metabolize drugs differently and may express different adverse effects). At the time Hillary Clinton risked “family-values” ire by lambasting the Bush administration an “Evidence Free Zone” for their anti-science stance.
    I’m having severe buyer’s remorse. As Drew Westen ad Paul Krugman have argued out Obama is simply hollow. He may have his heart in the right place but his fights have been half-hearted and his strategy clumsy. His failures on things that matter most -climate change- have been inexcusable. All he has ever really done is give a speech. “There is not red state america or a blue state america but a united states of america blah blah blah..” And legions of Democrats feeling all smug for despising Sarah Palin as an idiot got a hard-on and shooed this idiot in.

  12. Why not just go ahead for now and make the age a girl does not need a prescription to 13 or 14? Why sink the whole idea?

    Well, I guess this smells of another example where religion poisons everything.

    Screw reason ans screw common sense, we are talking politics and religion. Now that’s a lethal cocktail nobody needs a prescription for.

    1. Yes exactly. Sibelius could have accepted the application in part, but didn’t. I agree with most of the posters that this is a political move, not a science one, and a bad political move at that.

  13. Of course, those young women are not voters so they get no chance to make that choice of who decides these things either! Another reason why politicians should not make decisions better made by experts on the basis of EVIDENCE!

  14. “This is not a medical decision, but a cynical and political one.”

    I really can’t believe this is the case because if it is it would be the dumbest political decision ever.

    It would basically mean that Obama is completely clueless and actually dumb.

    1. no, it doesn’t.

      see the link to Greenwald I posted upthread.

      It’s correct to be upset that he hasn’t followed the progressive agenda (he lied), but not that what he did was stupid.

      hell, haven’t you noticed the repeated comments suggesting that NOT voting for Obama would be like voting for something worse that George Bush?

      why in the hell would he NEED to follow a progressive agenda in that climate?

      In fact, politically, he’s much smarter to try and attract any votes he can from other areas.

      Find someone else to take his place in the Democratic Primary, I say. Don’t make this about voting for Obama or tossing your vote away.

      Now is the time, during the PRIMARIES, to make your progressive voice heard. With the republicans working so hard at being “Twit of the Year”, what is there to lose by promoting other candidates within the Democratic Primary?

      1. I see you points with regards to voting for someone else in the Democratic Primary. I just don’t think it’s realistic to think that Obama is at all likely to have any serious challenger in the Primaries. He’s the incumbent and the incumbent always has a better chance of winning. I wasn’t able to find out much information about the candidate you mentioned upthread, but it would appear that he’s never held any governmental position. He has run for various positions, but always lost. Now if Dennis Kucinich were to enter the primaries race, I’d be interested. He seems to be a true progressive despite his Catholicism (I don’t know if he’s actually a practicing Catholic) Still, he’d never have a chance against Obama, though a series of debates between the two would be interesting.

  15. Don’t worry, the head of the NIH is bound to step in and address why science rather than religious considerations should underlie all policy decisions.
    To be serious for a second, Collins hasn’t pushed religion in terms of national policy (for instance he was always very pro-stem cell research) so it is not impossible that he might say something sensible on this one – although I doubt he will, he is a very political operator.

  16. Obama sure is trying to make people stay at home for the next election.

    But I guess this is what you get when you have 2-party political system.

    1. My guess is that he really, really wants people to vote for Ralph Nader.

      Why else would he alienate almost every Democratic voter in California, and many Republican ones, by cracking down on medical marijuana?

  17. I don’t agree with the criticism that this is entirely political. It may not even be partly political or influenced by the President. What Sebelius said was that there had been no studies of the effects of this medicine on girls as young as 11. If that is true, then the argument can be taken as a health-related proposition, and it is subject to objective evaluation. I do not pretend to know the medical science on this, but that is the domain that is cited for the decision.

    In politics as in science, it makes sense to weigh the pros and the cons of our ideas. Not supporting Obama means supporting Romney or Gingrich at the moment. What are the relative merits here?

Comments are closed.