Obama’s FDA Executive Order

To much hype, the Obama administration has issued an executive order (EO), allegedly designed to reduce the growing problem of drug shortages. This is undoubtedly a complex subject and there are a variety of factors at work, but the text of the EO reveals something quite different from what most reports suggest, namely that the administration plans to work with industry to make it easier for pharmaceutical companies to address the problem of product shortages.

In essence, the EO calls for three things: for more reporting by manufacturers when they think there will likely be shortages of their drugs; for expedited regulatory review in certain, limited circumstances; and for the FDA and the Department of Justice to seek out criminal activity, such as hoarding or price gouging.

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