FDA Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs

There is a need for more generic alternatives for complex drug products, and industry should not be deterred by some of the well-known challenges in developing them, a US FDA official told a recent conference. Instead, she said manufacturers should consult the product-specific guidance available for some of these products and leverage agency-sponsored research.

Concerns about the lack of generic availability of complex drugs were aired at a Sept. 12-13 FDA-sponsored workshop in Silver Spring, Maryland. The workshop explored how to spur the development...