A conservative health and public policy think tank reports on the consequences of a federally managed pharmaceutical approval and regulatory process and how that impacts patient access to timely and appropriate care — with respect to pharma availability. The Pacific Research Institute released its white paper detailing what it describes as the bureaucratic morass of “stymied pharmaceutical regulation” within the FDA’s drug approval process. A snippet:

During a 12-month period in 2008 and 2009, the European Union’s European Medicines Authority (EMA) and the Food and Drug Administration (FDA) approved a total of 39 new medicines. Fifteen were approved only by the FDA, 11 were approved only by the EMA, and 13 were approved by both regulators.

In five of the 13 cases where the FDA and EMA both approved the medicine, the EMA was the first to approve, and it issued those approvals 552 days faster than the FDA, on average. Even if we include all 13 medicines approved by the FDA and the EMA, the EMA approved those 97 days faster, on average.

The report goes on to describe the effects on impassive procedures of the FDA and its correlation to unnecessary medical tourism for similarly approved pharmacological treatments elsewhere. Although the report confirms what we all know about the costs of healthcare respect to governmental and regulatory mechanisms, perhaps this is another area in which Obama’s pick to head another regulatory agency addresses the need to apply quality and efficiency to the rather staid and arcane process of pharma approval.

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