Increasing Transparency in Generic Drug Applications Act

More FDA transparency for generic drugs

If enacted, FDA would have to tell companies whether a proposed generic's inactive ingredients are qualitatively and quantitatively the same as the brand drug. If FDA finds the generic is not the same, it would identify which ingredient(s) differ and say how much any numeric differences are. After a company files an ANDA, FDA generally could not change a prior sameness decision unless the brand drug's formulation later changed and the old version was withdrawn for safety or effectiveness, or FDA issues a written determination that an earlier decision was in error. If FDA issues a written change for an identified error, it would have to notify the requester and give a copy of the written determination. FDA would publish draft guidance within one year explaining how it will decide sameness, including how it treats pH adjusters. The public would have at least 60 days to comment, and FDA must publish final guidance within one year after the comment period closes. These disclosure rules would apply starting on the date of enactment.