In an interview with the Financial Times, outgoing GSK CEO Jean-Pierre Garnier shares his thought on the new, tougher FDA approval environment. While many drug developers hope the FDA's reticence to approve new drugs in the wake of recent safety scandals will fade over time, Garnier think the regulatory environment is irrevocably changed.
"The hurdle rate has gone up. It is not going to come down. This is not a pendulum. Society wants to avoid risk. We have to tease out rare side-effects earlier," Garnier observed. Blockbusters as we know them are a dying breed. Instead, he predicted that there will be more "progressive blockbusters," drugs approved for one indication that gain other approvals over time. This approach minimizes the risk that a marketed drug could cause serious side effects that were not observed during clinical trials.
- for more on Garnier's thoughts, see this article