It Seems The High Cost Of Drug Development Is Unsustainable. Should New Regulatory Pathways Be Considered?

A | THERE’S NO QUESTION THAT THE COST CURVE MUST COME DOWN FOR DRUG DEVELOPMENT TO REMAIN ECONOMICALLY VIABLE. Fortunately, Congress and the FDA have recognized the problem. Pursuant to new authorities and mandates in the 21st Century Cures Act and PDUFA VI, the FDA is taking several steps to improve the efficiency of clinical trials. For example, the agency recently published a framework for using real-world evidence (RWE) to help streamline clinical development and regulatory decision making. They also have acknowledged the value of novel endpoints in clinical trials and started an important pilot program to promote the use of complex innovative clinical trial designs. I believe that regulatory tools such as these will eventually lead to a notable reduction in the time and cost involved in drug development.

TOM DILENGE is president, advocacy, law, and public policy division for the Biotechnology Innovation Organization. Prior to joining BIO, Tom held senior roles at the House Homeland Security and Energy and Commerce Committees.