RESEARCH TRIANGLE PARK, NC--(Marketwire - September 30, 2009) - 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.
Contact Information: CONTACT:
Stephanie Swanson
919-433-0212