FDA's aggressive thoughts on off-label

WASHINGTON - The FDA is considering dramatic changes to increase approvals of new labels for already approved drugs, including actively soliciting supplemental new drug applications (SNDAs) and spending taxpayer funds on research that could expand label indications.

According to congressional testimony by Michael Friedman, the agency's deputy commissioner for operations, the FDA is also considering circumstances under which supplemental uses could be approved under revised scientific guidelines, or on the basis of well-designed studies published in the scientific literature...