FOBs go to court

A lawsuit filed in federal court last week by Sandoz Inc. against FDA and HHS over FDA's lack of action on the company's application to market its Omnitrope follow-on human growth hormone illuminates the agency's volte-face on follow-on biologics since former Commissioner Mark McClellan's departure in March 2004.

In 2003, when McClellan was leading FDA, the agency actively encouraged Sandoz and other companies to seek approval for follow-on versions of biologics that are regulated as drugs. But by August 2004, when FDA's review was completed, the agency said it could not act on the application due to unresolved scientific and legal issues...