Today, the House of Representatives unanimously passed H.R. 5651, the Food and Drug Administration Reform Act of 2012. The landmark legislation includes two bipartisan bills authored by Representative Brian Bilbray to promote innovation and create jobs in San Diego.
"The passage of the FDA Act will not only improve patient care, but it will give our life science industry the certainty it needs to grow and continue creating high-paying jobs in San Diego," stated Bilbray, member of the House Energy and Commerce Committee with FDA oversight.
The FDA Act reauthorizes the five-year $6.4 billion user fee for programs governing prescription drugs, generic drugs and medical device industries. Due to the bill's importance to both patient care and the life science industry, it was given "must-pass" status in Congress well in advance to the current law's September 2012 expiration.
"The legislation will enhance product safety and development, as well as bring more innovative therapies to patients faster," stated Joe Panetta, President and CEO of BIOCOM. Panetta went on to praise Bilbray, "Your intervention on behalf of the patient advocacy community and the life science industry in the development of this bill is to be commended."
According to BIOCOM, Southern California's life science industry employs over 97,000 employees with average incomes of $50,000 to $100,000 dollars. Approximately half of Southern California's life science industry employees are located in San Diego County.
"San Diego is uniquely positioned to benefit from the passage of this bill. Along with "Biotech Beach,' we also have a thriving medical device, pharmaceutical and industrial biotechnology sectors that will all benefit," noted Bilbray, "Also, with close to one-third of life science jobs coming from research and development, my bills to expedite FDA review will keep us competitive on a global scale."
Working with patient and industry groups in San Diego, Bilbray crafted two bills that won bipartisan support and were included in the landmark FDA legislation. Specifically, the two bills authored by Bilbray include:
H.R. 3203, the Novel Device Regulatory Relief Act, coauthored with Representative Lois Capps (D-Santa Barbara) which improves the FDA's third party review and inspection of medical devices by making the process more efficient and transparent.
Another is H.R. 5334, the Breakthroughs Therapy Act, coauthored with Representative Diana Degette (D-Denver) which expedites the review of breakthrough drugs for patients with serious or life-threatening disease, or a condition where preliminary clinical evidence shows an improvement over existing therapies.
"I especially want to thank Congressman Bilbray for his efforts on the bipartisan FDA Reform Act. He worked with members on both sides of the aisle to achieve regulatory reforms that will improve patient care, and his bipartisan outreach helped ensure the bill passed with overwhelming support," added Representative Fred Upton (R-MI), chairman of the House Energy and Commerce Committee.
Congressman Brian Bilbray serves on the House Energy & Commerce Committee. This standing committee maintains one of the broadest jurisdictions of any Congressional committee with legislative oversight on communications, consumer protection, energy, environment, and health.
What Leaders of the Life Science Industry are Saying
" you have demonstrated thoughtful, principled and tireless leadership to advance bipartisan solutions that will improve FDA regulatory consistency and predictability, promoting continued biomedical investment, job creation and the development of safe and effective medicines and technologies for patients in need."
- Todd Gillenwater, Public Policy Senior Vice President of California Healthcare Institute
"The legislation will enhance product safety and development, as well as bring more innovative therapies to patients faster. Your intervention on behalf of the patient advocacy community and the life science industry in the development of this bill is to be commended."
- Joe Panetta, President and CEO of BIOCOM
"As a leading voice representing technology startup and emerging companies, FDA user fee reauthorization is a critical component in fostering young companies to grow, create jobs, and continue to revolutionize life-saving medical care. We are encouraged by the measured but quick pace the House has taken to advance the FDA user fee reauthorizations."
- Timothy Tardibono, Vice President of Public Policy of Connect
"The FDA Reform Act is landmark legislation not only for patient care, but for an industry working to bring life saving products and therapies to market. I applaud the efforts of the House of Representatives in addressing this issue prior to the September deadline. Particularly I applaud Congressman Brian Bilbray for his work to bring industry to the table during the development of this bill and building bipartisan consensus with his colleagues to ensure its passage."
-Ritchard Engelhardt, Vice President of Government Affairs of BayBio