Advanced Search
MyIDEAS: Login to save this article or follow this journal

US FDA Modernization Act, Section 114: Uses, Opportunities and Implications for Comparative Effectiveness Research

Contents:

Author Info

  • Peter J. Neumann

    (Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA)

  • Pei-Jung Lin

    (Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA)

  • Tom E. Hughes

    (Market Access and Reimbursement, OptumInsight Life Sciences, Eden Prairie, Minnesota, USA)

Registered author(s):

    Abstract

    Background: Section 114 of the 1997 US FDA Modernization Act (FDAMA) is an important vehicle for pharmaceutical companies to promote the economic value of their drugs to formulary decision makers, but little is known about how the Section has been interpreted and used. Methods: We conducted a web-based survey of a convenience sample of 35outcomes directors of major pharmaceutical and biotechnology companies. We asked them about their interpretation of, and experiences with, Section 114, as well as their views regarding the FDA's role in the matter, and whether the advent of comparative effectiveness research (CER) will affect the use of Section 114 promotions. Results: Of the 35 experts, 16 (46%) completed the survey. 81% stated they always or frequently consider using Section 114 when making promotional claims for drugs. 75% stated that the FDA should issue guidance on how to make such promotions to payers, especially what qualifies as "healthcare economic information" and "competent and reliable scientific evidence." Most expected to use Section 114 to a greater extent in the future, and agreed that the increased focus on CER would increase Section 114 use. Conclusions: The survey suggests strong awareness about Section 114 among the outcomes directors and some use of the Section for promotional purposes. It also reflects a belief that CER will increase use of Section 114 promotions, and that guidance from the FDA is needed. More clarity - and, ideally, flexible interpretation - from the FDA is warranted, especially given the rise of CER.

    Download Info

    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.
    File URL: http://PharmacoEconomics.adisonline.com/pt/re/pec/pdfhandler.00019053-201129080-00005.pdf
    Download Restriction: Pay per view

    File URL: http://PharmacoEconomics.adisonline.com/pt/re/pec/fulltext.00019053-201129080-00005.htm
    Download Restriction: Pay per view

    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.

    Bibliographic Info

    Article provided by Springer Healthcare | Adis in its journal PharmacoEconomics.

    Volume (Year): 29 (2011)
    Issue (Month): 8 ()
    Pages: 687-692

    as in new window
    Handle: RePEc:wkh:phecon:v:29:y:2011:i:8:p:687-692

    Contact details of provider:
    Web page: http://pharmacoeconomics.adisonline.com/

    Related research

    Keywords: Formularies; Legislation; Pharmacoeconomics; Regulatory-process.;

    Find related papers by JEL classification:

    References

    No references listed on IDEAS
    You can help add them by filling out this form.

    Citations

    Lists

    This item is not listed on Wikipedia, on a reading list or among the top items on IDEAS.

    Statistics

    Access and download statistics

    Corrections

    When requesting a correction, please mention this item's handle: RePEc:wkh:phecon:v:29:y:2011:i:8:p:687-692. 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: (Dave Dustin).

    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.