My guest post at Pharmalot is up on the GAIN Act. My bottom line: the GAIN Act is not a balanced approach to reducing the burden of infectious disease.
Meanwhile, the most under-reported health story of the year continues, as PDUFA V emerged from the Conference Committee with the new “fast track” accelerated approval standards in place – essentially permitting more drugs to reach US patients with shorter and less complete clinical trials. This is a major change in the trade-off between safety, efficacy and market access, the biggest since the 1962 amendments.
@koutterson
