FDA boss wants a better Orange Book

Scott Gottlieb, the Commissioner of the US Food and Drug Administration (FDA), is not satisfied with the progress his agency has already made under his leadership in creating greater competition in the pharma market.

There was a record number of generic drug approvals and tentative approvals from 2017 to 2018. Drugmakers have been helped by the FDA providing scientific clarity and guidance to support the development of hard-to-develop complex generics and calling out potential abuses of the system where companies were using tactics to delay market entry of competitors.

But Dr Gottlieb believes more can be done.