FDA moving on complex generics

FDA Commissioner Scott Gottlieb Monday rolled out new initiatives that are intended to facilitate the development and review of complex generic drugs. In a blog post, he defined complex generics to include drugs for which bioequivalence “can’t be easily measured in the blood, or when the drug’s therapeutic effect is delivered locally to a particular organ, rather than systemically, through the bloodstream,” as well as drugs that contain an “active mixture of components and not a single active molecule.”

As part of a broad effort to bring support development of complex generics, FDA released two draft guidances, one outlining special procedures for ANDA applications for complex products, and another clarifying the pathway for generic versions of synthetic peptide drug products of rDNA origin. FDA will provide companies seeking ANDAs for complex generics opportunities for meetings early in the product development process, and will implement other procedures to increase communication between sponsors and FDA review staff...