"In an August 2010 report analyzing our national enterprise for developing medical countermeasures (MCMs) against infectious diseases and bioterrorism, the United States Department of Health and Human Services (HHS) concluded that 'transformative changes' are needed. The report announced a series of government initiatives to effect those changes. The question is whether those proposals are sufficient to accomplish the needed transformation, or whether Congress must take more decisive actions to harness the power and innovation of private industry to accomplish this goal."
In this article, Druckman recommends that Congress should:
- Provide statutory exclusivity to the first company that licenses a universal influenza vaccine, following the Orphan Drug Act model.
- Create an alternate regulatory pathway for MCMs for which no private market exists and for which approval or licensure is unfeasible under certain requirements.
- Authorize and direct the U.S. Food and Drug Administration, when assessing the risk-benefit balance of MCMs being reviewed under an alternate regulatory pathway, to consider both the public health consequences of a disease outbreak or terrorist attack, and the likelihood of such an event.
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