Companies Push New Formulations for Blockbusters

Researchers from several universities say drug manufacturers pursue new formulations of blockbuster drugs and those granted accelerated approval, but do so less frequently once generic competition begins. Writing in JAMA Health Forum, the researchers say that in their cross-sectional study of 206 branded drugs approved by FDA in tablet or capsule form between 1995 and 2010, approval of new formulations was four times more likely among blockbuster drugs and 5.5 times more likely among drugs granted accelerated approval. “First new formulation approval was statistically significantly lower after approval of generic competition,” they write.

The article says new formulations have important consequences for patient access, clinical care, and health care finances. The study, they say, has implications for prescription drug pricing reform, patent law, and other incentives for pharmaceutical innovation.