Pandering To Religious Right or Science? FDA Nominee Must Choose

|

A lot of people concerned with the delays in obtaining FDA approval for the over-the-counter sale of the emergency contraceptive Plan B breathed a sigh of relief when it looked like the FDA was getting ready to move on the issue. Before traveling up to Capitol Hill for a hearing on his nomination as the new FDA commissioner, Andrew von Eschenbach announced he'd like to talk to Plan B's manufacturer about offering the contraceptive over-the-counter to women over the age of 18.

Hold on a minute. Why limit OTC availability to 18 year olds? The FDA scientific advisory panel voted overwhelmingly that Plan B was safe for use by women of any age. John Jenkins, director of the FDA's Office of New Drugs, wrote in an internal memo leaked to the Washington Post: "The agency has not [previously] distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case."

Von Eschenbach and the Bush Administration have not offered any scientific evidence that justifies limiting Plan B's OTC availability to women over the age of 18. They are sill playing politics aimed at appealing to the religious right that fears that unmarried women will feel free to have more sex if Plan B is easily obtainable at the corner drugstore.

The FDA is legally required to consider only the scientific evidence for safety and efficacy when approving new drugs. Von Eschenbach's scientifically unjustified limit on Plan B's availability shows that he is playing politics and disqualifies him as the new FDA commissioner.

NEXT: A Shout-Out to Tom Paine

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Okay, who else was disappointed to find a Ron Bailey article after clicking on the link promising “more sex”?

  2. If the sales are behind the counter it and over 18 -it’s still going to be easily available.
    Why shouldn’t anyone be able to semi-discretely pick it up without questions and i.d. like you can for condoms?
    In a emergency situation there’s a small window of time to use plan B and running around finding a pharmacy with their counter open isn’t always easy.
    You find this out when you are looking to get a prescription after hours.

  3. Von Eschenbach’s scientifically unjustified limit on Plan B’s availability shows that he is playing politics and disqualifies him as the new FDA commissioner.

    Don’t hold your breath for a suitable replacement.

  4. why doesn’t HTML work right on this site?
    I meant not easily available.
    Too early & not enough coffee.

    “Your comment submission failed for the following reasons:
    In an effort to curb malicious comment posting by abusive users, I’ve enabled a feature that requires a weblog commenter to wait a short amount of time before being able to post again. Please try to post your comment again in a short while. Thanks for your patience.”

  5. why doesn’t HTML work right on this site?
    I meant not easily available.
    Too early & not enough coffee.

    “Your comment submission failed for the following reasons:
    In an effort to curb malicious comment posting by abusive users, I’ve enabled a feature that requires a weblog commenter to wait a short amount of time before being able to post again. Please try to post your comment again in a short while. Thanks for your patience.”

  6. why doesn’t HTML work right on this site?
    I meant not easily available.
    Too early & not enough coffee.

    “Your comment submission failed for the following reasons:
    In an effort to curb malicious comment posting by abusive users, I’ve enabled a feature that requires a weblog commenter to wait a short amount of time before being able to post again. Please try to post your comment again in a short while. Thanks for your patience.”

  7. I’m starting to feel malicious about it posting anyway.

  8. Damn straight bitches!!!!

  9. The FDA only considering science is like Congress only considering the Constitution.

  10. Pandering!!
    Er, no, wait. I mean SCIENCE!
    What was the question?

  11. See Robert Formaini’s booklet, The Myth of Scientific Public Policy.

    FDA can always say they’re taking knock-on (no advantage, scrum here) behavioral effects into account in determining the safety of a drug or device. They routinely do so already, keeping many drugs in prescription-only status not because the drug or device itself would be dangerous OTC, but because patients would then skip seeing a doc for a serious condition.

  12. The FDA is a governmental, which means political, body.

    Why is anyone shocked to find it acting that way?

  13. RC, yes, the decision to look only at the safety and efficacy of a drug is a political decision, based on an ideology that assigns government the role of protecting consumers/patients from fraud. (If a supplier sells a drug as safe and effective and it is not, I’m defining that as fraud).

    Just as the decision to also look at the social effects created by a safe and effective drug’s availability is a political decision, based on an ideology that assigns government the additional role of steering the culture in certain directions.

    I would expect a libertarian like yourself to approve of an ideology that assigns protection from fraud to the government, and to oppose an ideology that promotes govenrment culture steering. Instead, you seem to be declaring both ideologies to be equivalent, and I cannot agree.

  14. I don’t thin anyone is shocked, RC. It’s pretty well known that Bush and his appointees, as conservative Republicans, wish to include the steering of culture towards “traditional family values” in the government’s responsibilities.

  15. an ideology that assigns government the role of protecting consumers/patients from fraud. (If a supplier sells a drug as safe and effective and it is not, I’m defining that as fraud).

    Serious hypothetical, Joe: would you support a situation where drug companies could sell their stuff without FDA approval, provided they were honest about the risks? I’m sure you’ve heard the old-but-true canard “if aspirin were invented today, there’s no way the FDA would approve it for over-the-counter status.” Yet I still take it from time to time, despite the risk of suffering one of the many, many severe side effects aspirin can cause.

    As an adult, I’m deeply resentful of government basically saying to me “I know you’re willing to risk taking this medicine, Jennifer, but we won’t let you take that risk and if you try you’ll go to jail.” This Plan B nonsense isn’t even the most egregious case–“Hi there, AIDS victim with only six months to live, you can’t have this experimental drug because it might kill you.”

  16. Y’know, if limiting OTC access to Plan B to women over eighteen is the only way to get any OTC access to Plan B at all, then I’m for it. Let’s not let this be one of those “all or nothing” things, i.e., if we can’t have a perfect solution we’ll have none at all. The FDA shouldn’t let non-medical considerations factor into its decisions; however, it does, and given that it does, this might be the best we can realistically hope for.

  17. I’d take this over lack of approval for OTC sales of Plan B any day.

  18. …the religious right that fears that unmarried women will feel free to have more sex…

    They act as if that were a BAD thing.

  19. Luckily, few girls under 18 know any women 18 or over, so the proposed restriction is likely to be highly effective.

  20. Y’know, if limiting OTC access to Plan B to women over eighteen is the only way to get any OTC access to Plan B at all, then I’m for it. Let’s not let this be one of those “all or nothing” things, i.e., if we can’t have a perfect solution we’ll have none at all.

    Easy enough to say when you’re on the closer-to-perfect side of the solution vs. the closer-to-nothing side.

    I’m one who says that a politically powerless group shouldn’t be used as a sacrifice just so a more powerful group can get their way. I love how the people who discuss how important OTCing this drug is are actually willing to deny it to teens just to better their chances of getting their way. Talk about cowardly. If it’s so safe, so effective, and so necessary to be OTC, why should it be harder for teens to get it?

    Yes, in this case, it should be all or nothing while acknowledging that the FDA has no right to force such a decision in the first place.

  21. Y’know, if limiting OTC access to Plan B to women over eighteen is the only way to get any OTC access to Plan B at all, then I’m for it. Let’s not let this be one of those “all or nothing” things, i.e., if we can’t have a perfect solution we’ll have none at all.

    Easy enough to say when you’re on the closer-to-perfect side of the solution vs. the closer-to-nothing side.

    I’m one who says that a politically powerless group shouldn’t be used as a sacrifice just so a more powerful group can get their way. I love how the people who discuss how important OTCing this drug is are actually willing to deny it to teens just to better their chances of getting their way. Talk about cowardly. If it’s so safe, so effective, and so necessary to be OTC, why should it be harder for teens to get it?

    Yes, in this case, it should be all or nothing while acknowledging that the FDA has no right to force such a decision in the first place.

  22. Nothing in the FFDCA allows FDA to condition OTC status for a drug on its being sold only to adults; all they can do is have the label of an OTC drug say it’s not for those under 18 YO. However, FDA has been negotiating conditional approvals with sponsors for marketing applications for drugs in recent years, e.g. for thalidomide. Legally these deals are unenforceable.

    However, the sooner this drug is marketed OTC to adults, the sooner a record of its safety in OTC use will start to accumulate, hastening the day when it will be licensed for OTC sale to children.

  23. I’m a supporter, generally, of parental notification. I have reservations about selling Plan B to minors without a parent’s knowledge…

    …and I agree with Ron Bailey. The FDA is playing the role of legislature here, legislature and executive rather, and it has no business doing so.

Please to post comments

Comments are closed.