Digging in heels on Omnitrope

As a federal court date nears in the dispute between Sandoz and FDA over the company's demand for timely approval of its Omnitrope follow-on version of human growth hormone, the government is now arguing that PDUFA deadlines are merely "aspirational" and FDA is only obligated to review the application.

The government's claim, made in a federal court filing last week, came as the dispute over follow-on biologics continued to spill over from the courts to Congress. In both venues, FDA is being accused of deferring actions for political, rather than scientific, reasons...