The FDA has approved the first set of vaccines aimed at preventing H1N1 infection after an approval process of less than four months. Cutting Edge Information is currently analyzing the lessons learned that may emerge for both the Food and Drug Administration (FDA) and life science firms after this crisis experience.
Due to the political and medical pressure brought by the potential pandemic, FDA rushed testing and approval of the newly released vaccines. How will these events affect the FDA's other accelerated-approval paths? For example, heightened urgency for drug approval is often found in oncology. This makes the FDA's cancer office a frequent focus of patient-advocate attention, as the New York Times discussed in an article published the day after the H1N1 vaccine's approval.
The article featured a picture of people marching for the approval of Provenge. This novel treatment for prostate cancer was overwhelmingly approved by an FDA committee in March 2007. But since then, the drug has been in limbo while different parts of the FDA decided whether more testing was necessary. The H1N1 vaccines were approved in four months while a drug likely to extend the life of a prostate-cancer patient has been delayed two and a half years -- much longer than many of those patients could wait.
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.
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