Recommendations for FDA to Meet Needs of Small Populations Suffering Serious Diseases in Manhattan Institute White Paper

Developing a set of recommendations for the future of the Food and Drug Administration

The Manhattan Institute for Policy Research released a white paper on June 8, 2006, with recommendations on how to reform the pipeline for new medications, including the approval process by the Food and Drug Administration (FDA).

The white paper, Prescription for Progress: The Critical Path To Drug Development, was written in response to a 2004 FDA report that concluded that the lengthy and costly approval process hinders development of treatments for small populations of patients with certain serious diseases.

Key Recommendations

  • The FDA should manage the process of identifying biomarkers, which are molecules in the human body that correlate with the risk of a particular disease or with its susceptibility to treatment.

  • The FDA should implement a new approval process in which drug manufacturers could garner the go-ahead to market drugs to small subsets of the patient population, adding other groups over time.