25 June 2018 - The FDA is working to modernize the clinical trial process in order to answer the right questions about today’s innovative cancer drugs, but regulators need help from payers—or, more precisely, from their data, according to FDA Commissioner Scott Gottlieb.

Gottlieb called for more data sharing during remarks at the National Comprehensive Cancer Network Policy Conference, taking place in Washington, DC, on June 25. The commissioner covered 4 policy areas he said were linked by “the need to modernize drug development to harness the full medical potential of this rapidly advancing science, while ensuring that innovation remains affordable for patients.”

He added that patients will not benefit from outdated regulatory frameworks that keep life-saving drugs off the market, while stretching out the process and making drugs more expensive. While FDA does not have direct authority over drug costs, Gottlieb said a different approach can take time and costs out of the approval process, while promoting competition and encouraging generics and biosimilar development.

Read American Journal of Managed Care article