Industry Distribution Of Journal Articles Ineffective, ASHP Tells FDA

Main Category: Pharma Industry / Biotech Industry
Article Date: 08 May 2008 - 7:00 PDT

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The pharmaceutical industry's distribution of journal articles on off-label uses to healthcare providers is ineffective and inappropriate; ASHP recently told the Food and Drug Administration (FDA) in comments on its draft guidance outlining good reprint practices for drug manufacturers to follow when providing health providers with information on off-label uses.

In its comments, ASHP urged the FDA to reinstitute its formal review of manufacturer-distributed journal articles. Short of reinstituting that process, ASHP recommended several changes to the draft guidance, including adding language that notes that journal articles should include information from clinical trials that fulfills the requirements of a formal FDA clinical investigation.

The Society is ASHP is concerned that widespread, off-label uses of medications could result from unsolicited, industry-distributed promotional materials. These medications could be used for alternative treatment regimens not supported by clinical trials and without oversight by authoritative bodies such as the FDA.

Click here to read ASHP's comment letter.

American Society of Health-System Pharmacists