Last week's hard-hitting report on the FDA by the Institute of Medicine lays out several common-sense reforms that should be embraced wholeheartedly by the biotech industry--if for no other reason than avoiding the backlash over drug safety that the report represents. First, the days when a drug developer could ignore post-approval safety studies are over. I think most everyone realized that already. Serious limitations should be placed on marketing new therapies and mandatory posting of clinical trial data is an absolute must. I think most in the industry would also welcome an increase in budget and staffing at the FDA. It's also clear--and encouraging--that the FDA evidently recognizes that business as usual won't pass muster with the public. The alternative--more stonewalling and bureaucratic inaction--is likely to lead to a Congressional backlash that would inflict damaging penalties and excessive bureaucratic controls over the development process. Some balance is going to be required here. We need to improve drug safety while advancing the Critical Path Initiative's goal of streamlining the approval process. For biopharma, it's time to adapt to a new reality and encourage change. - John Carroll