Marketing Off-Label Uses to Physicians: FDA's Draft (Mis)Guidance

Avoiding bias and incorrect confidence interval coverage in prescription drug labeling

“…There are thousands of peer-reviewed journals and companies' selection of articles may be biased toward those that illustrate the utility of the treatment in the most favorable light. 10 Adding reliable information in labeling would help, as FDA guidance indicates that approved labeling should be included with any peer-reviewed journal information disseminated to physicians. 9 A second argument against this alternative labeling approach is that it might discourage sponsors from obtaining reliable information, and potentially carrying out additional studies, to evaluate important secondary endpoints.…”