Ideas. Action. Results.

Bill Frist and Bart Gordon: Develop Drugs With Data

U.S. News & World Report

Monday, July 11, 2016

With continuing advances in science and technology, the pace of medical breakthroughs is accelerating. Today, we can treat or even cure conditions that significantly shortened life just a generation ago. The exciting promises of personalized medicine are now becoming reality.

But bringing new drug discoveries to patients remains a slow process. On average, it takes 10 years and $2 billion to bring a new medication to market. With 10,000 known molecular-based diseases, and approved treatments for only 500 of them, the urgency of finding the next generation of cures is clear.

Real-world data – data already amassed in electronic health records and other clinical software, claims systems and even in patients’ personal health tracking devices – is a rich source of information that can play a key role in accelerating the Food and Drug Administration’s approval process for promising drugs and devices to patients in need. While the use of real-world data in pre-market evidence development is not specifically prohibited by law, the lack of clarity regarding its use to support drug approvals has hindered its incorporation.

As co-chairs of the Bipartisan Policy Center’s initiative on Advancing Medical Innovation, we have been working with experts and stakeholders to explore a range of ways to improve the discovery, development and delivery of cures for Americans. Last year, the center released recommendations in a number of key areas that we felt were ready for bipartisan action. One of those recommendations was to expand the generation and use of real-world evidence to enhance research and shorten the pathway to drug approval, while maintaining the highest standards of safety.