Government Initiatives

Recognizing the promise of, and challenges to, the discovery of new medicines, the U.S. Department of Health and Human Services (HHS) recently created a Task Force to encourage innovation in healthcare.

"Recent advances in basic sciences, such as genomics, proteomics, and bioinformatics, have created the potential for the development of innovative medical technologies that can provide new hope and better quality of life for many Americans."

"Nonetheless, there is concern that [despite record levels of public and private investment in research] new discoveries are not rapidly translating into new medical products for patients."
- HHS, May 24, 2004 Federal Register notice

The HHS Task Force's work is building off initiatives within some of the key HHS agencies to spur pharmaceutical innovation, particularly the Food and Drug Administration's (FDA) Critical Path initiative to improve the predictability and efficiency of drug research and development and the National Institutes of Health's (NIH) Roadmap for Medical Research initiative to help speed the movement of research discoveries from the laboratory to the patient.

Explaining the importance of its Critical Path initiative, FDA said: "Today's revolution in biomedical science has raised new hope for the prevention, treatment, and cure of serious illnesses. However, there is growing concern that many of the new basic science discoveries made in recent years may not quickly yield more effective, more affordable, and safe medical products for patients. This is because the current medical product development path is becoming increasingly challenging, inefficient, and costly."

Similarly, the NIH Roadmap seeks to identify and address the key issues in speeding the translation of new scientific discoveries into new medical technologies. In announcing the Roadmap, NIH Director Elias Zerhouni, M.D., said: "There has been a scientific revolution in the last few years. The opportunities for discoveries have never been greater, but the complexity of biology remains a daunting challenge."

The Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations dedicated to continued pharmaceutical innovation identified a number of key steps to improve the process of discovering new medicines and ensuring they are available to patients. These include:

Support for FDA's Critical Path initiative
Coordination of other initiatives such as the NIH Roadmap initiative with FDA's Critical Path project
Collaboration between FDA, NIH, and public stakeholders to identify and validate biomarkers (biological indicators of the effect of a medicine)
Support for basic research at NIH into diseases that are not well-understood, such as osteoarthritis and Alzheimer's disease
Facilitate research on tests and therapies that help prevent disease before it emerges rather than treating it once it does
Establish reimbursement policies that support continued innovation