June 01, 2008
DC battle erupts over off-lable reprints
An FDA plan to allow drug companies to distribute reprints of journal articles dealing with off-label drug uses has run into fire from Sen. Charles Grassley (R-IA), Public Citizen and two university professors even as an industry coalition began efforts in April to have the FDA loosen its proposal.
In a letter to the FDA's commissioner, Grassley asked for an explanation of the rationale behind an agency draft guidance on off-label promotion that he said appears to cede agency authority to the regulated companies. The draft guidance, he complained, would expand industry's ability to promote off-label use of drugs and devices through distribution of scientific literature supporting the off-label use, despite growing evidence of industry efforts to manipulate scientific literature.
Grassley said the decision not to require companies to submit a supplemental NDA or obtain an exemption from that requirement essentially ensures there would be no review by FDA of data that under an expired provision of the FDA Modernization Act would have been available to the agency under the supplemental application process.
Public Citizen said the draft guidance is a “gift to industry.” “Once the drug has been approved for a single indication,” Public Citizen said, “and thus has its proverbial foot in the door, the industry could turn to its marketing arm to exploit the drug's full financial potential by promoting unproven, off-label uses without having to engage in a sometimes lengthy, expensive, and unpredictable effort to secure formal FDA approval.”