Are We Gonna Hurry this Along or What?

There are multiple companies working to develop a H1N1 flu vaccine in time for mass vaccinations this fall and the media is doing a good job of publicizing the necessary clinical trials (well, at least for large academic research centers...the private sites who are probably doing a larger volume of the trials seem to be left out in the wilderness to do their own advertising) needed to complete the development process. However there is one thing worth mentioning that needs to be addressed before we get too far along into the Northern Hemisphere flu season:

What is the FDA doing, exactly? The FDA is trusted with the not so desirable task of regulating the medication/vaccine/device industry in the United States and they must walk a delicate line between a rapid development process and ensuring the safety of the millions of people who may receive a product once approved. The issue is that like many other government agencies, there is significant red tape and there seems to be no real timeline that the FDA follows when working with drug developers. Ordinarily the only people a regulatory delay significantly affects is the developer, but this an entirely different situation. The media makes a big deal out of the implications of a deadly, virulent pandemic on not only the health care system, but also the economy, so one would think that there would be a real sense of urgency from the FDA to get this vaccine (as well as any new treatment for the illness, more efficient diagnostic tools, etc). Unfortunately, I don't get the impression that this is the case. There are situations where a study is ready to start and just before the anticipated start date...the FDA says "stop, we need to talk about changing a few things." What is wrong with this picture? The FDA technically has up to 30 days upon receipt of a prospective protocol to advise for any changes, and they often use as much of that time as possible. According to the regulations the agency can take their time, but should they in this situation?

What I think would make sense is for the FDA to have a 1 business day turnaround time for any H1N1 related protocol. Even if they do request changes, it at least would give the sponsor enough time to implement them without disrupting the enrollment or time lines of the study (hopefully). To the sponsor, although we may not want to admit it, time is money and while it is a great thing to develop the next pandemic vaccine, there are millions (if not billions) of dollars to be had from a successfully developed vaccine. For the rest of us, the longer that we have to wait for clinical trials to start, the more likely it is that we will have a significant pandemic problem starting any day now.

You could argue that the H1N1 crisis is not the only thing on the FDA's plate, but there are few other situations with the potential explosiveness of this one. FDA needs to step up to the plate and quicken their processes before this swine flu gets out of hand.