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Complex Generics: Gottlieb Eyes FDA Policy Changes To Speed Approvals

 
• By Sue Sutter

US agency could reconsider requirement that instructions for use be same for branded and generic products, FDA Commissioner-nominee Scott Gottlieb suggests, while also leaving door open to statutory changes in Hatch-Waxman Act.

Syringes stuck in a dartboard

The US FDA should explore administrative steps within the existing Hatch-Waxman framework to smooth the abbreviated new drug application (ANDA) process for complex generics, but congressional tweaking of the landmark law might be necessary, commissioner-nominee Scott Gottlieb said at his April 5 Senate confirmation hearing.

FDA needs to “develop better scientific principles” for assuring substantial equivalence of ANDA products when traditional measures of bioequivalence may not be adequate, Gottlieb

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