Sometimes you wonder just how loudly a message has to be delivered before the FDA will respond. There has been steadily mounting evidence, capped by today's GAO report, that the agency has allowed drug developers to play fast and loose with the rules for post-market safety studies. Could it be too much to expect a simple restructuring that would allow safety experts at the FDA to operate independently of the drug review group? And can Congress get its act together to agree, on a bipartisan basis, that a system that increasingly relies on post-marketing studies in order to speed the approval process needs to require these follow-on studies? If the agency and lawmakers would like to demonstrate their independence of drug makers--as well as some simple common sense--here's its shot. It has a new FDA commissioner to get through the nomination process and a clear public mandate to perform. The timing is perfect. - John Carroll