FDA Commissioner responds to GAO report on handling of complex generics

FDA Commissioner Scott Gottlieb has responded to a US Government report which criticised the unpredictability of changes the agency makes to guidance on complex generics.

This type of product is often based on a complex formulation or complex active ingredient which may make it more difficult for generics manufacturers to demonstrate equivalence with the reference product, compared with conventional generics.

The report stated that the FDA “issues new guidance documents and revises existing ones unexpectedly, which can create setbacks for generic drug companies.”