Off-Label Drug Practices vs. FDA Efficacy Requirements
The amended Food, Drug and Cosmetics Act requires efficacy certification for a drug's initial uses ("on-label"), but does not require certification before physicians may prescribe the drug for subsequent uses ("off-label"). Does it make sense to require FDA efficacy certification for new drugs but not for new uses of old drugs? Using a sequential online survey, we carried on a "virtual conversation" with some 500 physicians. The survey asked whether efficacy requirements should be imposed on off-label uses; almost all physicians said no. It asked whether the efficacy requirements for initial uses should be "dropped", and most physicians said no. We then asked respondents whether opposing efficacy requirements in one case but not the other involved an inconsistency. In response, we received hundreds of written commentaries. We organize and discuss these commentaries with an eye to understanding how the medical market certifies off-label drug uses and how this compares to FDA certification. Does off-label medicine use suggest that efficacy requirements should be placed on new uses of old drugs? Does it suggest that efficacy requirements on new drugs should be lifted? We explore these questions, and ask whether the response of many of the doctors exhibits the familiar behavior bias toward the status quo. Copyright � 2008 American Journal of Economics and Sociology, Inc..
If you experience problems downloading a file, check if you have the proper application to view it first. In case of further problems read the IDEAS help page. Note that these files are not on the IDEAS site. Please be patient as the files may be large.
As the access to this document is restricted, you may want to look for a different version under "Related research" (further below) or search for a different version of it.
Volume (Year): 67 (2008)
Issue (Month): 5 (November)
|Contact details of provider:|| Web page: http://www.blackwellpublishing.com/journal.asp?ref=0002-9246|
|Order Information:||Web: http://www.blackwellpublishing.com/subs.asp?ref=0002-9246|
When requesting a correction, please mention this item's handle: RePEc:bla:ajecsc:v:67:y:2008:i:5:p:743-775. See general information about how to correct material in RePEc.
For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: (Wiley-Blackwell Digital Licensing)or (Christopher F. Baum)
If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.
If references are entirely missing, you can add them using this form.
If the full references list an item that is present in RePEc, but the system did not link to it, you can help with this form.
If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your profile, as there may be some citations waiting for confirmation.
Please note that corrections may take a couple of weeks to filter through the various RePEc services.