SAN DIEGO, CA, July 9, 2012 – 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 healthcare innovation community work together with our elected officials on this legislation that speeds medical device innovation and lowers costs in the healthcare system, benefitting 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.”