Friday, January 9, 2009

The FDA's Culture of Fear

In an article by the Wall Street Journal titled "FDA Scientists Ask Obama to Restructure Drug Agency" , they discuss a letter written by several FDA scientists to Obama's transition team. The letter explicitly tells of fishy business going on within the agency including a culture of fear among the honest employees. The "corrupt" agency employees have created an uncomfortable environment for those without their hands in the industry's pocket. It seems obvious that a regulatory group of an extremely profitable industry would have corrupt infiltrates, but to have such an openly sensed fear from those scientists who are truly trying to objectively analyze the data on drugs, devices, and other treatments, is a devastating reality.

Can we not find a balance between the profit incentives for innovation and public safety? The pharmaceutical industry as well as the device industry surely have developed some incredible, life saving and quality of life-improving things. At the same time that we embrace this and appreciate it, we must remember that regulation should do just as its name describes, regulate. Obama and Daschle need to work very hard to make sure the FDA remains as uninfluenced and corrupt-free as possible in order to maintain a scientifically objective regulatory body for the industry. This could mean reorganizing and self regulation improvements.

In return for record profits, all we ask is that the data these companies provide as proof for their product's success be scrutinized to the fullest extent- without worry that industry profiteers are letting them slide through unscathed.

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