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announcing their issuance of draft Guidance for Industry of Information on Unapproved Uses of Medical Products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on the draft, which they will accept until 60 days after the Federal Register notice of the availability of the draft guidance (4/21/08). The actual title of the document is more explanatory, “Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses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announcing their issuance of draft Guidance for Industry of Information on Unapproved Uses of Medical Products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on the draft, which they will accept until 60 days after the Federal Register notice of the availability of the draft guidance (4/21/08). The actual title of the document is more explanatory, “Draft Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses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
3 Comments:
Dear Tad,
I am a Ph.D. chemist with an interest in medical writing. I came across your blog via the AMWA listserv. I must say that I have enjoyed reading your blog. Given my novice status I will report on my limited understanding of the FDA guidance.
I read the following site.
http://www.fda.gov/oc/op/goodreprint.html#introduction
If I had to paraphrase what I understand, which is limited, the FDA is trying to establish Good Reprint Practices (GRP), a series of guidelines for how written information should be treated and disseminated, a series of standards for the writing community. This document establishes what type of writing is acceptable, much like GMP and GLP establish criteria in for how a manufacturing and laboratory should be run.
My interpretation is that the FDA realizes that there is a body of medical writing out there and it wishes to establish rules and norms by which medication information is dispersed. It seems to me that GRP might actually be an attempt to impose structure over an area that is lacking in it. Again, this is an outsider and novice opinion of what I read.
As I am unaware of the history behind this guidance. Perhaps I am not qualified to comment. Can you give some history or background to what led up to or prompted this action by the FDA? There must have been something that initiated this action.
Wanda
This is a good explanation:
http://www.virsci.com/pmnews7_2kvari.pdf
Wanda,
The link you left:
http://www.virsci.com/pmnews7_2kvari.pdf
actually has an excellent historical overview and should have answered your questions.
It appears to me that the draft guidance proposed by the FDA is lax because legislators have not provided a good substitute for section 401 of the FDA Modernization Act of 1997, which expired in 2006.
Thanks for your interest.
Tad
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