FDA issues draft guidance document on good reprint practices

[Guest guest]

FDA Issues Draft Guidance Document on Good Reprint Practices

 

David Kailin, Ph.D., M.P.H., L.Ac.

 

 

On February 15, 2008, the FDA released a draft guidance document for

drug and medical device manufacturers on good reprint practices to be

used when informing medical professionals about unapproved new uses of

drugs or devices. Guidance documents do not create new duties, but do

express agency recommendations. A public comment period on the draft

guidance will be open for 60 days commencing from 02/15/08.

 

The draft guidance document pertains to manufacturers, a term which

FDA indicates as including sponsors, licensed distributors, and

marketers of drugs and medical devices. The guidance applies to the

unrequested dissemination of information about off-label uses, and

does not apply to unsolicited requests for information.

 

Because promotion of off-label uses is not permissible, the guidance

serves to direct appropriate communications from manufacturers about

those uses. Disseminated journal articles that address off-label uses

should not be written or edited by (or at the behest of) the

manufacturer, nor in the form of a supplement funded by the

manufacturer. Articles should come from peer-reviewed sources,

overseen by editorial boards with expertise in the subject area of

interest and independent of the publisher. Articles should not be

false or misleading, nor provide information that poses a risk to

public health. Articles should address controlled clinical

investigations or significant non-clinical research.

 

Only unabridged article reprints should be sent, and not merely

abstracts. Reprints should not contain highlighting or summaries by

the manufacturer, and (if reprints lack it) should be accompanied by a

bibliography of any additional research articles addressing the

off-label use. If contrary conclusions have been reached in other

research reports, the manufacturer should also include a reprint of

such a report. Promotional materials should not be physically

attached to reprints. Reprints may be distributed at medical

conferences, but should not be distributed in promotional exhibit areas.

 

A statement should be fastened to reprints that the uses are not FDA

approved or cleared. Manufacturer's and author's interests in the

drug or device, and study funding sources, should also be expressed.

If the manufacturer is aware of risks not discussed in the reprint,

those should be stated. The approved labeling of the drug or device

should also be supplied.

 

Text of the draft guidance document:

http://www.fda.gov/oc/op/goodreprint.html.

 

To submit comments:

http://www.regulations.gov.

Enter the following Docket number under Comments or Submissions:

Docket No. FDA–2008–D–0053

 

 

David C. Kailin, Ph.D., M.P.H., L.Ac.

Author, Quality In Complementary & Alternative Medicine

http://www.convergentmedical.com