Oct 2011 - FDA Commissioner Releases Blueprint to Drive Innovation

Interestingly, the FDA, once thought of as only the watchdog of industry, is now working on defining a role for helping create solutions.  The Medical Device Summit (http://www.medicaldevicesummit/) presented the following article:

"Monday, October 10, 2011 8:02 AM

FDA Commissioner Hamburg Releases Blueprint to Drive Innovation

Dr. Margaret Hamburg, Commissioner of the Food and Drug Administration has released a blueprint for spurring innovation in life sciences, saying that there aren’t enough products in the medtech pipeline. 

"The number of new products in the development pipeline is not where we would want it to be and it's not commensurate with the medical and public health need," Hamburg said while launching the blueprint “Driving Biomedical Innovation: Initiatives for Improving Products for Patients." 

This includes calls for the federal watchdog agency to improve "consistency and clarity in the medical device review process," rebuild its outreach offering for small businesses and focus on developing personalized medicine, according to a press release.

"We know that investment in biomedical research and product development are at all-time highs – last year an estimated $100 billion from the public and private sector – but the return on investment, in terms of new products for people and to the companies, has not been what was expected," Hamburg said. "Timelines are long, costs are high, rates of failure are distressingly high, so this is a critical time to come together to address this important issue for people and for our nation."

The blueprint will address seven areas, namely: 

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

FDA is also launching an Entrepreneurs in Residence program to bring outside experts into the fold. This includes the recently-retired Medtronic CEO Bill Hawkins (who recently assumed charge as CEO of blood screening and equipment company Immucor). This initiative is aimed at improving the agency's understanding of "the business context that is important for us to better understand as we undertake our regulatory review."

“We think that it’s very, very important that we have this kind of cross-fertilization, with industry and academia and government all working together to help ensure that we have the understanding and the systems in place and the tools that we need to be able to translate from scientific discoveries into real-world product," she said.

Other members of the Entrepreneurs in Residence team include: Jeff Allen, Friends of Cancer Research; Riley Crane, MIT Media Lab; Dr. Elazer Edelman, MIT/Harvard Medical; Dr. Thomas Fogarty, Fogarty Institute for Innovation; Mark Jeffrey, Kellogg School; Dean Kamen, DEKA Research; Anjali Kataria, Conformia; Jack Lasersohn, The Vertical Group; Dr. Roger Lewis, UCLA Medical Center; Dr. Jeffrey E. Shuren, FDA, among others."

 

Clearly, the FDA is recognizing that it plays a critical role in facilitating or NOT facilitating innovation in industry, and it is wise to include business leaders like Bill Hawkins in the process.  We will look for more progress over time.