The FDA, for most of the past 10 years, was the regulatory agency that many people in biotech and pharma loved to hate. Critics have long complained about bureaucratic foot-dragging, byzantine organization, poor communication, excessive aversion to risk, and arbitrary decisions around whether to approve new drugs for sale in the U.S.
But FDA bashers, at least in the pharmaceutical world, haven’t had much to complain about in 2012. Suddenly the FDA and the pharma industry it regulates look like best pals. The FDA, under commissioner Margaret Hamburg, has been making noise for some time about its desire to not just ensure the safety and effectiveness of the U.S. drug supply, but to also help promote the development of innovative new medicines. This year, the agency has absolutely done everything it can to back up its rhetoric with actions that prove it isn’t an adversary but more of a partner in the development of new medicines.