The former FDA Commissioner Dr. Andrew von Eschenbach has made bold statements in the past, and it once again publically stating his recommendations for the Agency. Previously he argued that efficacy should be removed from the initial FDA approval process, so FDA can focus solely on safety. He believed this would help medical device manufacturers introduce products to market faster and provide quicker access to patients on novel therapies.
The story was covered in a Healing Innovation article and emphasized how the FDA approves medical devices on both safety and effectiveness while other regulatory bodies approve medical devices based on safety. It argues that the “effectiveness” standard is what causes clinical trials to last so long causing delay to approval of devices.
Everyone would agree that the win-win is for safe, clinically effective products to reach patients as quickly as possible. But how can innovative products find a quicker path to market? In an article published in The Wall Street Journal Eschenbach calls for three changes which would speed devices to the patients that desperately need them, urging FDA to:
- Focus on new approaches to clinical trials with a greater emphasis on computer modeling
- Provide more proactive post-market surveillance for medical devices
- Increase industry collaboration
The former commissioner bluntly advises faster approvals as the “medical device industry flourishes overseas, even as it struggles under unnecessary regulatory burdens in the U.S.” Regulations exist to ensure patients are protected and resulting data from clinical trials has integrity, but at what point do they hinder instead of help?
Do you agree with the wish-list to speed devices to patients? If you would add anything, or would like to share your thoughts, please post them below!
Photo Credit: Leo Reynolds