FDA Guidance on off label journal article use
On 2/15/08 the FDA made a news release (can't get link to work so you must cut and paste!)
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
announcing their issuance of draft Guidance for Industry of Information on Unapproved Uses of Medical Products
www.fda.gov/oc/op/goodreprint.html
and stating that they welcome public comments on the draft, which they will accept until 60 days after the Federal Register notice of the availability of the draft guidance (4/21/08). The actual title of the document is more explanatory, “Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”
To view the comments that have been submitted see
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-D-0053
I work freelance for many pharmaceutical companies and I imagine they welcome the changes proposed in the draft. This may be sticking my neck out a bit, but I am concerned that given the opportunity to essentially market off label use by disseminating journal articles reporting the results of off label use, pharmaceutical companies will have no incentive to properly test new uses for approved drugs and that, as a result, the public safety will be at risk. I prefer the FDA to require pharmaceutical companies to go through existing procedures before allowing approved drugs to be used for new indications.
Could this be yet another instance of the Bush administration rendering regulatory agencies powerless over the industries they were set up to regulate?
What do you think?
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html
announcing their issuance of draft Guidance for Industry of Information on Unapproved Uses of Medical Products
www.fda.gov/oc/op/goodreprint.html
and stating that they welcome public comments on the draft, which they will accept until 60 days after the Federal Register notice of the availability of the draft guidance (4/21/08). The actual title of the document is more explanatory, “Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.”
To view the comments that have been submitted see
http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-D-0053
I work freelance for many pharmaceutical companies and I imagine they welcome the changes proposed in the draft. This may be sticking my neck out a bit, but I am concerned that given the opportunity to essentially market off label use by disseminating journal articles reporting the results of off label use, pharmaceutical companies will have no incentive to properly test new uses for approved drugs and that, as a result, the public safety will be at risk. I prefer the FDA to require pharmaceutical companies to go through existing procedures before allowing approved drugs to be used for new indications.
Could this be yet another instance of the Bush administration rendering regulatory agencies powerless over the industries they were set up to regulate?
What do you think?
posted by Tad B. Coles, DVM | 1:29 PM
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3 comments
