SNDA approvals, off-label dissemination to be subjects of Rep. Shays oversight hearing Sept. 12.

SUPPLEMENTAL NDA APPROVALS HOUSE OVERSIGHT HEARING TO FEATURE GAO REPORT, recently updated, on the prevalence of off-label uses. The General Accounting Office estimates that "80%-100% of cancer, pediatric and rare disease patients are using off-label drugs," Rep. Shays (R-Conn.) announced Sept. 5. The full report, which updates a 1991 GAO study, will be released Sept. 12 at a hearing on supplemental NDAs held by Shays' House Government Reform/Human Resources Subcommittee.