FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe

In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs (read "FDA Issues More Guidance Regarding Distribution of Reprints. Is It 'Fair and Balanced?'").The draft guidance states: "FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study" if the study or analysis meet specific conditions (read about the conditions here).In a JAMA Internal Medicine viewpoint article published today, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, argues that the draft guidance "suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products" and would "let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling."Does Wolfe have a case?Read more »
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: FDA Guidance off-label promotion Reprints Source Type: blogs