San Diego-based West Wireless Health Institute, BIOCOM, and CONNECT Applaud President Obama Signing FDA User Fee Bill into Law

Streamlines patient access to new, innovative products

SAN DIEGO, July 9, 2012 /PRNewswire-USNewswire/ -- The West Wireless Health Institute (WWHI), BIOCOM and CONNECT today applauded President Obama for signing S. 3187, the Food and Drug Administration (FDA) Safety and Innovation Act. This act contains important provisions ensuring FDA-regulated products have a safe and effective pathway for regulatory approval to help bring new technologies to patients faster and at a lower cost.

The three Southern California advocacy organizations worked extensively with legislators on the bill. It is expected to expand the FDA's use of an accelerated approval process and provide transparency, predictable performance goals and other ways to foster early, more regular and interactive communication between the industry and reviewers during the regulatory process. The bill includes important requirements that deal with the development of antibiotics, help speed the FDA's de novo process, and are expected to foster expedited advancement of therapies for patients suffering from serious and life-threatening diseases.

Last fall, WWHI, BIOCOM and CONNECT all testified before the House Energy and Commerce Committee on the importance of streamlining FDA's approval process, offering recommendation on improvements to regulatory pathways. WWHI testified in support of revising the FDA de novo process, which previously forced manufacturers of new but low-risk medical devices through an onerous, time consuming process before the agency would review it, a process that has now been streamlined. BIOCOM and CONNECT supported a "breakthrough therapies" provision to create a designation devised to expedite the development of targeted drugs when early evidence shows promise as more effective than existing marketed products for serious or life-threatening conditions. Rep. Brian Bilbray (R-CA) was particularly helpful in revising the FDA's de novo designations as well as the "breakthrough therapies" provisions that were subsequently incorporated into the legislation by Reps. Bilbray and Lois Capps (D-CA).

"The entire mobile health ecosystem is developing inherently low-risk technologies to extend care beyond offices and hospitals, and these novel, low-risk devices and integrated solutions can be expedited via these changes to the FDA's de novo pathway," said Dr. Joseph Smith, Chief Medical and Science Officer of the West Wireless Health Institute. "It's great to see our region's health care innovation community work together with our elected officials on this legislation that speeds medical device innovation and lowers costs in the health care system, benefiting patients through common sense policies that safely expedite approvals."

"Many BIOCOM member companies have one thing in common: their fate is dependent on the FDA. Without FDA approval during each step of the commercialization process, nothing else matters," said Joe Panetta, BIOCOM President and CEO. "During the course of the debate, BIOCOM weighed in with Congress by communicating the importance of specific parts of the legislation.  BIOCOM praises Congress for addressing industry concerns and is pleased with the final outcome.  The FDA reforms help create a more predictable, safe and effective regulatory process that encourages the immense investment to get a concept from discovery to commercialization, giving patients access to high quality products in a timely fashion."

Duane Roth, CEO of CONNECT, emphasized the importance of the bill stating, "As a leading voice representing startup and emerging companies, we applaud the FDA reforms included in the bill because they will help spur young companies to grow, create jobs, and continue to revolutionize life-changing medical care.  In a time when gridlock is more common on Capitol Hill, it is heartening to see Congress act in a bipartisan manner to ensure that our life science innovators in San Diego and throughout the U.S. can stay focused on developing breakthroughs that save lives and improve health."

ABOUT THE WEST WIRELESS HEALTH INSTITUTE

The West Wireless Health Institute is an independent, non-profit 501(c)(3) medical research organization whose mission is to lower health care costs by developing innovative patient-centered solutions that deliver the right care at the right place at the right time. This is accomplished by conducting innovative medical research, educating key stakeholders and advocating on behalf of patients. Solely funded by pioneering philanthropists Gary and Mary West, the Institute is located in San Diego, California, the global center for health care innovation.  For more information, find us at www.westhealth.org.

ABOUT BIOCOM

BIOCOM is one of the largest regional life science associations in the world, representing more than 550 member companies in Southern California. The mission of the organization is to accelerate life science success. The association focuses on initiatives that position the region's life science industry competitively on the world stage, and on the development and delivery of innovative products that improve health and quality of life. This includes initiatives in capital formation, public policy, workforce development, and member services. More information about BIOCOM can be found at http://www.biocom.org.

ABOUT CONNECT

CONNECT (www.connect.org) catalyzes the creation of innovative technology and life sciences companies in San Diego and has assisted in the formation and development of more than 3,000 companies in the San Diego region. The organization is widely regarded as one of the world's most successful organizations linking inventors and entrepreneurs with the resources they need for commercialization of innovative products in high tech and life sciences. CONNECT has been recognized by TIME, Inc. and Entrepreneur magazines and in 2011 won the national State Science and Technology Institute's 2011 Excellence in Tech Based Economic Development Award for Building Entrepreneurial Capacity. In 2010 CONNECT was the recipient of the Innovation in Economic Development Award from the U.S. Department of Commerce for creation of Regional Innovation Clusters.

SOURCE The West Wireless Health Institute, BIOCOM and CONNECT