A New Way to Propel Drug Innovation and Improve Available Treatment Options

In a report last month to the President, his scientific advisory board proposed a potential plan to accelerate the Food and Drug Administration’s (FDA) current drug approval process as a way to propel drug innovation. FDA Commissioner Margaret Hamburg made a similar report to the scientific advisors of the FDA, noting the purpose of such a plan would be potential societal health benefits. The proposed accelerated corridor would be reserved for those drugs with indications for infectious diseases, weight-loss treatments, and to combat drug-resistant bacteria. Hamburg noted, “This is an issue of having the right science and data to assess risks and benefits but also a broader societal discussion about risks and benefits that individuals and communities are willing to take on and under what circumstances.” Allan Coukell, deputy director of medical programs for the Pew Health Group in Washington, concurs with both the advisors to the President and the FDA that the proposed approval acceleration plan for certain drugs “would be good for developers, for companies and it would be good for the public health.”



Jaime Gilmore is an Audit Director performing audit services as well as SEC compliance, revenue recognition, equity based compensation and other complex equity instruments.

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