Impact of Precision Medicine Initiative on FDA

It is always good when the President of the United States provides a positive focus on biomedical research and development. Here is a condensed version of what the President said:

Investing in R&D, in Key Areas from Precision Medicine to the BRAIN Initiative: America's long-term economic competitiveness and growth depend on robust investments in research and development (R&D), which provide the foundation needed to further grow the economy. The President is calling for a major increase in R&D investments, including precision medicine, combatting antibiotic resistance, and the President’s signature BRAIN Initiative.

What created the most attention was the Precision Medicine Initiative:

The President’s proposal would invest in precision medicine, an innovative field that provides healthcare professionals with tools, knowledge, and treatments to tailor care to a person’s unique characteristics – such as their genetic makeup. Recent advances in genomics and digital data have produced powerful new discoveries about health and disease that have made it possible to design highly effective, targeted treatments for cancer and other diseases.

The President’s intent was further expanded upon in the White House blog.What about FDA? As most of us already know, FDA is deeply involved in precision medicine, which is more typically called personalized medicine. The President’s reference to the new life-sustaining drug for cystic fibrosis doesn’t credit any agency. However, it was made possible in part by FDA working extensively with patient groups and the sponsor over many years.If monies are attached to this precision medicine initiative — and there really needs to be for it to be effective — then FDA should receive some of these monies to increase its ability to work in this vital area. We will know the answer to this when the President’s budget request is released on February 2.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.