La Jolla, Calif. (PRWEB) March 08, 2012
California Healthcare Institute (CHI) President and CEO David L. Gollaher, Ph.D., issued the following statement regarding today’s House Energy and Commerce Committee Subcommittee on Health hearing, “FDA User Fees 2012: Hearing on Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain,” where issues related to antibiotic development – including the Generating Antibiotic Incentives Now (GAIN) Act – were discussed:
“Since their discovery, antibiotics have improved the quality and length of life for countless people globally. The widespread use of antibiotics has accelerated the emergence of microbial resistance, weakening their effectiveness in treating evolving pathogens. In the U.S. alone antibiotic resistance infections cause 100,000 deaths each year.
"While the threat of antibiotic resistance is becoming more prevalent, the drug development pipeline has substantially slowed down. Antibiotic approvals by FDA from 1983 to 2007 declined by 75 percent. The threat of antibiotic resistance faces economic, scientific and regulatory barriers.
"To address this growing public health crisis, the Generating Antibiotic Incentives Now (GAIN) Act, a bipartisan and bicameral effort led by Reps. Phil Gingrey (R-GA), M.D. and Anna Eshoo (D-CA) in the House and Sens. Richard Blumenthal (D-CT) and Bob Corker (R-TN) in the Senate, was introduced in 2011 to help spur the development of new antibiotics. The GAIN Act provides the necessary economic incentives for innovator companies to encourage investment in antibiotics and supports expedited approval.
"Given the importance of developing new antibiotics, CHI urges Congress to support the GAIN Act, and encourages FDA to reconsider its regulatory pathway. This legislation will help rebuild our nation’s antibiotic pipeline and is a critical first step toward addressing antibiotic resistance.
"CHI supports further improving the FDA processes and management to better reflect the rising and urgent medical and public health needs resulting from regulatory uncertainty and unpredictability in the antibiotics space. Including the GAIN Act into must-pass legislation – the Prescription Drug User Fee Act (PDUFA) – is the best and only opportunity for Congress to address the issue of antibiotic resistance in 2012. We believe that industry, government and regulators must work together to develop ways to encourage adequate investment in antibiotic development.”
To read more about CHI’s initiative to promote antibiotic discovery and development, or about the GAIN Act, click here.
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI’s website is http://www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and Youtube.