lifescienceIn preparation of a developing pandemic of any kind, whether it be influenza, or some other kind of fast spreading virus, the Food and Drug Administration (FDA) has devised a precautionary plan known as the FDA Pandemic Preparedness Strategic Plan.  The FDA Pandemic Preparedness Strategic Plan is coordinated with the President’s National Strategy for Pandemic Outbreaks, as well the CDC’s Pandemic Implementation Plan.  Under these guidelines the FDA works under federal and local levels to effectively contain a pandemic outbreak, if possible, and do whatever is in their power to minimize the harmful effects of an outbreak.  But what is the FDA’s Pandemic Preparedness Strategic Plan, and what does it mean to a normal citizen, like me or you?

The FDA Pandemic Preparedness Strategic Plan is a plan strategically shaped to coordinate Federal, State, and local levels of government, to work together to prepare for, and ultimately minimize the effects of a pandemic outbreak, such as the Influenza outbreak of 1918, or the recent pandemic, known as the Swine Flu.  The plan involves coordinating federal and local authorities to develop enough domestic vaccine production capacity, sufficient to provide enough vaccines to accommodate for the entire U.S. population.  The FDA would make sure that the vaccines developed are safe and effective enough to give to the population as a whole, as well as providing cross-protective immunity.

The FDA’s Pandemic Preparedness Plan also relies on the availability of improved diagnostic devices, which can be readily available, and can also detect pandemic viruses, as well as differentiate between seasonal viruses, and viruses that have pandemic potential.  This differentiation is important for not only effective patient management, but for effective pandemic preparedness and response.  The FDA will provide proper guidance to the use of the point-of-care tests, in both pre pandemic, and post pandemic phases.

However, some critics have their doubts on whether this plan can actually be fully implemented in an effective manner in case of an actual pandemic emergency event.  Critics are using such emergencies like the aftermath of Hurricane Katrina, as a catalyst of doubt, that the government can effectively handle and control a national crisis.  They are also using other national emergencies such as the terrorist events of 9-11, to point out an example of the lack of coordination between Federal and State authorities in case of a widespread emergency.  Because of these widespread doubts many citizens are taking matters into their own hands, and getting flu vaccinations on their own.

But is this FDA Preparedness Plan actually a viable option response to a real viral pandemic? Many have their doubts.  One of the major doubts people are having is whether the FDA can effectively create enough vaccines to have a real impact on a pandemic outbreak, if one were to break out unexpectedly.  The pharmaceutical industry, as well as many life sciences consulting firms, are having their doubts as well.  Upon witnessing the recent shortage of H1N1 flu vaccines, the pharmaceutical industry as a whole doubts that the FDA could effectively coordinate the mass amounts of vaccines need to quell a real pandemic outbreak.  Only time will tell, but the FDA stands firmly behind their Preparedness Response Program, and stands by its claims that it is ready for anything.


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