California Healthcare Institute (CHI) Antibiotic Discovery and Development Initiative to Combat Public Health Crisis, National Security Threat, Economic Burden
Since the earliest discovery, the global use of antibiotics has improved the quality and length of life for countless people. However, the widespread use of antibiotics has accelerated the emergence of microbial resistance, weakening their effectiveness in treating evolving pathogens. The Centers for Disease Control (CDC) has defined antimicrobial resistance as a major public health issue, and the World Health Organization (WHO) has identified it as one of the three greatest threats to human health. The elderly, patients undergoing surgery, transplant recipients, infants all with compromised immune systems, face the greatest risk from these virulent pathogens. The rise of globalization, migration, trade and travel means that no country can isolate itself from resistant bacteria. Additionally, virtually all of the resistant pathogens can be bioengineered and manipulated to become resistant to all currently available treatments.
Just as antimicrobial resistance is increasing, the production of new FDA-approved antibacterials has decreased precipitously over the past 25 years, and the number of antibacterials in clinical development remains small. Approvals by FDA from 1983 through 2007 declined by 75 percent, with evidence of continued decrease in approvals, even during the most recent five year period. In addition to the dearth of new antibiotics in the pipeline, the number of truly novel compounds with a new mechanism of action is even smaller. Most late-stage antimicrobials do not promise a major advance in our ability to treat infection.
“While the need for effective antibiotics is clear, the drug development pipeline has not kept pace,” said David L. Gollaher, Ph.D., CHI’s president and CEO. “The most important barrier to investment is the FDA regulatory process but we are confident that the FDA has the power and ability to solve this problem.”
Antibiotics are different from most drugs in a company’s development pipeline. They are prescribed for short, defined periods of time and are intended to cure the patient of a condition. The typical development of resistance assures their eventual obsolescence, often before the patent expires and investors are able to recoup their investments. Concerns about over-prescription of antibiotics aggravating the issue of drug-resistant pathogens place additional limits on the market.
“While there’s a trend toward developing new business models to support innovation in anti-infectives, drug manufacturers have found it difficult to balance their cost and pricing structures to reflect the full value of these much-needed medications,” said Peter G. Milner, M.D., F.A.C.C., executive vice president, Optivia Biotechnology. “Industry and governments must work together to develop ways to encourage adequate investment in anti-infective development.”
The CDC estimates that healthcare-acquired infections cost hospitals in the U.S. between $35.7 and $45 billion annually and account for 8 million extra days of hospitalization, with $20 billion annually in excess costs related to resistant organisms. Antibiotic resistant organisms account for an estimated 2 million hospital-acquired infections annually and result in more than 100,000 deaths. Efforts to treat with broad spectrum antibiotics have accelerated the emergence of even more resistant and virulent organisms.
To address the growing public health catastrophe, a bipartisan effort is underway in Congress, led by Rep. Phil Gingrey (R-GA), M.D., and Sens. Richard Blumenthal (D-CT) and Bob Corker (R-TN), who recently introduced the Generating Antibiotic Incentives Now (GAIN) Act that seeks to spur development of new antibiotics.
“The GAIN Act provides the necessary economic incentives for innovator companies to encourage investment in anti-infectives and supports expedited approval,” said Gollaher. “CHI lauds the efforts of Gingrey, Blumenthal and Corker, as well as bill co-author Anna Eshoo, for their thoughtful leadership on this issue and developing legislation in response to critical needs for antibiotic development.”
Specifically, the GAIN Act seeks to:
• Extend the Hatch-Waxman provisions related to data exclusivity by five years, plus six months for products with companion diagnostic tests
• Provide priority review by the FDA
• Make products eligible for fast-track designation by the FDA
• Require a review of FDA guidelines regarding requirements for approval of antibiotics
“As a long-time investor in biomedical technologies, I believe this is a first step in the right direction,” said John G. Freund, M.D., managing director at Skyline Ventures. “This looming public health crisis is much more serious than most of the public, government or FDA realizes. Bacteria continue to evolve resistance to existing antibiotics, and they do not wait for us to act. The situation will only get worse in the next 10 years unless strong steps are taken to enhance the attractiveness of investing in antibiotic discovery and development, and to streamline the ability of drug developers to make new antibiotics available to physicians and patients.”
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 www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.