On June 18th, 2018 the US Food and Drug Administration (FDA) announced it would use congressional funding to update generic drug labels. Furthermore, FDA plans to begin with cancer drugs.
In a blog post, FDA Commissioner Scott Gottlieb said the agency would use $37.6 million to fund two new initiatives, reported RAPS.The first initiative involves creating a new review platform known as the Knowledge-aided Assessment & Structure Application (KASA). The second initiative updates the labeling of generic drugs.
Gottlieb wrote in his post, “Consistent with our current authorities, which allow for certain types of labeling changes to continue to be made for generic drugs after the brand drug is withdrawn, this budget request will provide the funding to allow the FDA to assume more responsibility to help bring these drug labels up to date. We intend to launch this initiative initially for oncology products.”1
As generic drug labeling changes has become the focus of recent court rulings, Gottlieb also said that the KASA will allow FDA to provide earlier feedback to generic drug makers. This was done with the hopes to reduce multiple cycles of application reviews. 1