Why Won’t FDA Approve Morning After Pill?

This great column in the Washington Post is the most eloquent, clear, and coherent statement about the current problems at the FDA I have read in some time. The author, Susan F. Wood, is a “former assistant commissioner of the Food and Drug Administration,” so she knows whereof she speaks. In her own words:

Time and again in my travels I am asked, “What happened to derail Plan B?” I have to answer honestly that I don’t know. The manufacturer agreed to take the “controversial” issue of young teens’ access to emergency contraception off the table in 2004; now we are talking only about adult access to safe and effective contraception. Over 98 percent of adult women have used some form of contraception. So what is the objection?

What indeed. This ongoing nightmare defies explanation. The morning after pill is “not RU-486, the ‘abortion pill.'” It is a contraceptive; millions of women use contraceptives all over the world. They are legal: in fact

emergency contraception has been used as a method to prevent unintended pregnancies for decades by women who had physicians advise them on how many pills in their regular pill pack to take. So people who are comfortable with oral contraceptives as methods of contraception should be just as comfortable with emergency contraception.

Of course, that’s the problem in a nutshell. There is a small but vocal group of voters who are not comfortable with contraception at all:

Modern contraceptive inventions have given many an exaggerated sense of safety and prompted more people than ever before to move sexual expression outside the marriage boundary

A big hand for Focus on the Family folks! This is really what’s going on in all this. Certain elements within the Republican party are opposed to contraception in all forms. They aren’t able to pursue the issue openly, because contraception is very popular, so they are trying to limit it as best they can. More people need to be bringing up issues like this:

It’s been nearly three years since the first application came in to make Plan B emergency contraception available over the counter, so that women, including rape victims, could have a second chance to prevent an unintended pregnancy and the need for an abortion. How many chances have we missed? I still can’t explain what is going on here, and why women 17 and older are still denied this product in a timely way. When did adult access to contraception become controversial? And why have we allowed it to happen?

Why indeed. As a great woman once said, “women’s rights are human rights.” Let’s protect them.

13 Replies to “Why Won’t FDA Approve Morning After Pill?”

  1. Why doesn’t the writer see the same thing about other social issues. Or is that just her politics. Every day advances in DNA and genetic research tell us that we can define a person by the genes they carry. Whether it is sickle cell anemia, Tay – Sachs, or aggression it is all defined by our genetic make up.
    She wants a pill, but not a reason for our numerous racial and social problems. Duh, go figure.

  2. I’m not sure I see what you mean, Ralph. The difference between a contraceptive pill, to prevent unwanted pregnancy, and some sort of pill that, as you suggest, alters our genetic makeup to solve diseases or behavioral problems is quite a large one. Not to mention the ethical questions raised by attempting to treat “aggression” or “racial problems” with a pill.

    In other words, I worry about defining societal problems by race or by genetics. The point of our society is that every person has rights and can participate equally. Indeed, that is the very reason we should push the FDA to respect womens’ rights and approve this pill.

  3. Ralph is just trolling and trying to use the old straw man style of non-debate at which the Rovians excel. The scariest wingnuts are the ones who have a smidgen of science knowledge (which they wouldn’t have had it not been for, oh, humanism and the Renaissance), but use their knoweldge to create false arguments and undermine the source of that very knowledge.
    “Forgive them, Father, for they know not what they hath done” indeed.

    Between the American Taliban and the Islamofascists, I’m afraid we’re headed towards the beginning of another Dark Age. Long live reason; reason is dead.

  4. I agree with you that it is irritating to see science used to assault knowledge. I remain unsure what, precisely, Ralph was suggesting above, but, as I said, I do worry when he suggests a “medical” solution to any “racial” problem.

    As for reason, sometimes I feel the way that you do, that the forces of ignorance are marching to cover the whole world. But I think there is reason for hope. Americans do not want to live in a nation of ignorance, and one day they will wake up and end the problem at the voting booth. We can hasten that day by making our voices heard.

  5. Susan Wood writes that the “morning after” pill “is simply a higher dose of daily birth control pills”. But one needs a prescription for daily birth control pills. Thus it is Woods who is engaging in politics, not science, by advocating the over the counter sale of Plan B.

  6. Patrick, you do raise an interesting point, although I disagree with your abrupt conclusion that Ms. Wood is not engaging in science by supporting over the counter sale of the morning after pill. I am more mystified by your assertion that she is engaging in politics.

    There are clear reasons why the morning after pill makes good sense as an over the counter medication. 1st, its effectiveness is based on how quickly it can be obtained and used, making a prescription impossible; 2nd, its safety has been verified by the FDA, even though the committee then failed to approve the drug; and 3rd, women ought to have the right to make medical decisions for themselves, when those decisions are warranted and safe.

    It seems to me that opponents of the morning after pill being available over the counter are engaging in politics, not science.

  7. Hmm Patrick, I’m a male. You’re (apparently) a male. Why does only one of us (apparently) think that what a woman does with her body is *her* business?

    You idiots make me sick.

  8. To Vienna, I apolagize that my lack of intelligence causes you to be sick. I merely wanted to point out that there is a rational basis for the FDA not to rush to release the morning after pill for over the counter sale given that it is a stronger version of medications which are presently available only through prescription. If reasoned discussion makes you ill, then perhaps you should turn to other pursuits.

    To Walrus, I confess that my original post apparently erred on the side of brevity. Let me expand the point I was trying to make. Given that ordinary birth control pills are available only by prescription (presumably based on sound medical reasoning) then it only follows that a stronger version of the same medication should likewise be available only by prescription. To advocate that a stronger medication be released over the counter while the milder is available only by prescription certainly appears to be an argument motivated by politics, not science. The fact that Ms Woods makes presisely this accusation against her former colleagues at the FDA (a case of projection?) merely strengthens my position.

    The fact that the effectiveness of the pill is a function of how soon it is taken after sex, is inapposite to my position. The point raised by Woods was whether the FDA was following a correct scientific protocal.

    As to your third point about a woman’s right to make medical decisions, etc., that raises the whole abortion issue which was not the subject of either Woods editrial or my reaction to it. (Of course should you wish to discuss that issue feel free to contact me.)

  9. Patrick, without getting into any other issues, I’d like to engage in this discussion a little further. I do see what you are saying in regards to the morning after pill being similar to medication currently available only by prescription. Here is a story from CNN that covers the issues in a brief way. The FDA studied the drug, and the board recommended approval of the over the counter availability of the pill. Now, I am not an expert, and neither, I assume, are you. I don’t mean that as a criticism, but rather as a way of saying that, in general, we ought to trust the scientific board of the FDA.

    I do not agree with you that, because the morning after pill is similar to a prescription only product, it should only be available in the same way. I do not know the correct outcome, and neither do you. The medical professionals at the FDA do, and their judgement was not repsected in this matter. I think this was for political reasons.

  10. Walrus, you are correct that I am not an expert. I also agree with you that scientists should stick to science and leave the politics to the politicians and the voters. Which leads to an additional criticism of Ms Wood’s editorial. Not only was her argument logically invalid, it also misconstrues the proper roles of policy and science.

    The acting director of the FDA is a political appointee. What is the problem with a political appointee making a political decision? Even if Woods were correct that the Plan B pill satisfies the accepted scientific protocals (a point which she fails to establish in her piece and on which we are both admitedly incompetent to decide) what is wrong with policy makers making a political decision? Bush is the president, not Woods and not the scientists with whom she agrees. He gets to appoint the policy makers who decide FDA policy regardless of the underlying science. Would you rather be ruled by unelected, and unaccountable, scientists

    The political decision that Woods accuses the FDA of maknig is consistent with the political orientation of the President. If Woods doesn’t like it, then she should exercise her political right to support policy makers whose views are more consistent with hers.

  11. Sadly, you lost me with your latest comment Patrick. I do not believe that the politicization of the FDA is a good thing. The FDA’s job is to approve or deny a variety of claims that medications and their manufacturers make. Claims to safety and effectiveness, for example. There should not be any political aspect to this work, because it is based on science. Is the drug safe? Does it function as claimed? The answers to these questions are not political, but scientific. A panel of FDA scientists studied the various claims surrounding the morning after pill and decided that it satisfied the requirements necessary for an over the counter medication. This was not a political decision.

    Only after this took place did politics enter the question. The FDA stalled and obfuscated, and that brings us to the present moment. A safe and effective pill has been kept off the market for political reasons, and that is the irritant in this case. I disagree with your premise that the President should be able to decide the outcome of every process that takes place in the government. We have a government of laws, not of men.

    In a hypothetical case, if the President were a Christian Scientist who believed that no medications ought to be provided to any person for any reason, would you support him or her shutting down the FDA all together? Perhaps you would; I would not. The government has a greater responsibility to the health and well-being of its citizens than to the wishes of its Executive Branch.

  12. Walrus, you miss mt point. The solution to unacceptable political decisions is political. To answer your hypothetical, I would oppose such a person by supporting his or her opponent. That is precisely what our government of laws (not men) provides.

  13. Patrick, I don’t think I am missing your point so much as I am disagreeing with you. I see what you’re saying, but I don’t think it is correct. You are describing exactly the sort of thing that the founding fathers referred to as the tyranny of the majority. Some things should not be political. Medical regulation is one of them.

    I believe that all citizens have the right to effective, safe medical care, regardless of who is in power at a given time. Safety and effectiveness can be determined using a non-political set of criteria. A drug that is unsafe while Jimmy Carter is President will be just as unsafe when Ronald Reagan is President. There should not be a difference in how the medication is handled just because of who won an election.

    Reading over your posts I see that you essentially argue that, since the morning after pill is similar to prescription medications, and since Ms. Wood advocates over the counter availability of it, she is “clearly” engaging in politics. I think that is not correct, for the reasons I stated in my post above. For the pill to be effective it should not require a prescription, and it is safe enough not to require one. Thus it ought to be available over the counter. None of this should be political; everyone’s health suffers when it is made so.

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