The seeming incongruence is partially explained by experts' worst-case scenarios for H1N1. But the two patient populations facing death are roughly similar in size. The H1N1 achievement now requires a closer examination of how the entire drug development and approval process can be improved so that critical new treatments reach as many people in time as possible.

How can the FDA apply the processes from the H1N1 crisis to speed up approval times, especially for drugs on an accelerated-approval path? Can more cancer drugs gain approval more quickly with an increase in political pressure? Should drugs that could extend or save lives be paused for extra efficacy studies when the patients are willing to try them?

The drug approval process is complex and patient safety requires protective measures. With clear answers to the questions above, Cutting Edge Information hopes to see the FDA, pharmaceutical, biotechnology, and medical device companies, and clinical research organizations work together to ensure that critically ill patients have speedier access to potential cures.

SOURCE: Cutting Edge Information