Senate FDA Reform Bill More Flash Than Action, Expert Says

A bulky new Senate bill intended to boost transparency of FDA operations is merely a splashy suite of ornamental add-ons that lack key metrics for success, a former agency executive says. The Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA Act of 2012 (the PATIENTS’ FDA Act), S.2292, charts six titles over 55 pages, but is unlikely to dramatically alter the way the agency works, Peter Pitts, a former FDA associate commissioner, said.
Devices & Diagnostics Letter