Tuesday, October 11, 2011

New Ideas to Spur Innovation

FDA Commissioner Margaret A. Hamburg M.D., released the document “Driving Biomedical Innovation: Initiatives for Improving Products for Patients” to address the sustainability of the medical product development pipeline which is slowing down despite record investments in R&D.

The blueprint focuses on:

• Rebuilding FDA’s small business outreach services
• Building the infrastructure to support personalized medicine
• Creating a rapid drug development pathway for important targeted therapies
• Harnessing the potential of data mining and information sharing while protecting privacy
• Improving consistency and clarity in the medical device review process
• Training the next generation of innovators
• Streamlining and reforming FDA regulations

Go to www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm274333.htm to view the document.

In another move, affecting medical device development, FDA and CMS have launched a parallel review pilot program to use when reviewing medical devices for FDA approval and Medicare coverage. Often device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming.

Both agencies rely on clinical data in reaching their decisions and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce the time between FDA approval and Medicare national coverage determinations.

The pilot program is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. The review pilot is only available for qualifying new medical device technologies.

The pilot program will last for up to two years with possibilities for extension will focus on innovative technologies that can benefit from the efficiencies of parallel review. The pilot program will accept no more than three to five submissions per year.

“The pilot program will help FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices,” said Jeffrey Shuren, M.D., Director of the FDA’s Center for Devices and Radiological Health.

Go to www.ofr.gov/OFRUpload/OFRData/2011-25907_PI.pdf to view the Federal Register notice. For questions, email Marham C. Luke at luke@fda.hhs.gov.