The FDA's promotion of generics

In September 2018, the US Food and Drug Administration issued 54 product-specific guidance documents containing methodologies and evidence to support the development of generic drugs.1 Each document provides the latest in a series of steps undertaken by the FDA and the US Congress to combat high drug prices by encouraging the production of quality generic drugs, writes Dr Nicola Davies in her monthly FDA blog for The Pharma Letter.

A month later, the FDA announced a record number of generic drug approvals - 781 approved and 190 tentative approvals. This continues a trend of increasing approvals that began in 20152when the FDA received more resources to deal with its backlog of generic drug applications. While it is too early to gauge the impact of these new guidance documents on approvals, it is hoped that they, along with other policies, will fast-track the FDA’s goals of promoting generics and increasing competition.

Why are generic drugs important?