Roskam, Davis Introduce Bill to Encourage Next Generation Antibiotics

WASHINGTON, D.C. – Today, Reps Peter Roskam (R-IL) and Danny Davis (D-IL) introduced H.R. 4187, the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act. This bipartisan legislation addresses the critical shortage of research and development for the production of advanced antibiotics that can treat resistant bacterial infections. 

The Roskam-Davis legislation addresses each of the four “core actions” identified in a November 2013 report from the U.S. Centers for Disease Control (CDC) as critical to combating the looming healthcare crisis of antibiotic-resistant bacteria and reducing preventable deaths, including preventing infections and the spread of resistant bacteria, better tracking of resistance and antibiotic use, improved use of antibiotics, and the development of new antibiotics to treat resistant infections.

“I’m pleased to join my Illinois colleague Congressman Davis in introducing the DISARM Act, which works to remove barriers to the research and development of advanced antibiotics to effectively treat resistant infections,” Congressman Roskam said.  “At present, there is a significant unmet medical need for therapies that can effectively treat resistant infections, a situation that is very serious and has prompted alarm bells from our nation’s best physicians and scientists, including those at the NIH and CDC. This legislation takes concrete steps to get companies back in the market to develop new antibiotics so that we can continue to stay on the leading edge of medicine and fight back against the superbugs that are increasingly impervious to even our toughest treatments.”

“The CDC, the NIH and other leading national and international scientific bodies have expressed growing concern about the rapid spread of antibiotic resistance,” Congressman Davis said. “Antibiotic resistance stems from a variety of causes ranging from the overuse and misuse of antibiotics in humans and animals, to genetic mutations and selective evolutionary pressures on bacteria arising from the widespread use of antibiotics.  It is my hope that this legislation will become a part of a comprehensive, evidence-based response to this emerging threat.”

BACKGROUND:

Superbugs are strains of bacteria that are resistant to several types of antibiotics.

Each year more than 2 million people suffer antibiotic-resistant infections, and 23,000 of them die as a result.  Studies put the cost of superbugs to the U.S. healthcare system at $20 billion per year, with another $35 billion in lost productivity.

The GAIN Act became law in 2012 to create a fast-track FDA review process for new antibiotics, streamlining the pathway to eliminate government barriers to developing drugs in this class.                         

Congressmen Roskam and Davis’s DISARM Act focuses on the private sector and remaining obstacles preventing pharmaceutical manufacturers from working in this space.

• First, by changing the payment and delivery systems that make it undesirable for companies to pursue new antibiotic treatments, the legislation will encourage a renewed interest in rebuilding our antibiotic arsenal. 
• Second, the legislation establishes a landmark study coordinating the efforts of the Government Accountability Office (GAO), National Institutes of Health (NIH), Centers for Disease Control (CDC), Food and Drug Administration (FDA), and U.S. Patent and Trademark Office (USPTO) to identify obstacles to a vibrant and competitive advanced antibiotics marketplace. The study will also produce recommendations to eliminate government red tape, improve financial incentives, coordinate research and development efforts, and comprehensively address the looming health crisis we face from a dried up antibiotic development pipeline.

In 1990, there were nearly 20 pharmaceutical companies with large, active antibiotic research and development programs. Today only three large and a handful of smaller companies continue in these efforts, and in many ways, on a more limited basis.

According to an April 2013 report by the Infectious Diseases Society of America (IDSA), there are just a handful of new drugs in development now for the treatment of multi-drug resistant infections.

The Roskam-Davis bill is backed by IDSA, as well as the Antimicrobial Innovation Alliance (AIA) and its member companies Achaogen, Astellas, AstraZeneca, Forest Labs, GlaxoSmithKline, Merck & Co. and The Medicines Company. Read the IDSA letter of support here, and the AIA statement of support here.

A background interview with CDC Associate Director Dr. Arjun Srinivasan calling for more action to combat antibiotic resistant infections and discussing the lack of pharmaceutical research and development for new advanced antibiotics can be found here.

Endorsements

Antimicrobial Innovation Alliance (AIA):

"We are writing to support your legislation that modifies the Medicare New Technology Add-on Payment (NTAP) program to address critical market barriers for much needed antimicrobial products...Your proposal would modifythe NTAP program to more appropriately reimburse for products targeting bacterial and fungal pathogens associated with high rates of mortality or serious morbidity, and for which we have no alternative treatments. This modification is an important incentive to support enhanced research efforts and could provide sufficient encouragement for manufacturers to remain in or reconsider antimicrobial product development."

Read the full letter here.

Todd E. Gillenwater, President & CEO, California Healthcare Institute (CHI):

"I am writing to thank you for your legislation (H.R. 4187, the Development an Innovative Strategy for Antimicrobial Resistant Microorganisms or DISARM Act) to promote research and development into needed new antimicrobial products....You legislation follows on the success of the 2012 Generating Antibiotic Incentives Now (GAIN) Act, also supported by CHI, which addressed the FDA regulatory framework pertaining to antimicrobials. Specifically, to further encourage and promote needed antimicrobial research, investment and innovation, DISARM would modify the existing Medicare New Technology Add-On Payment (NTAP) program to target products designed to treat the most dangerous bacterial and fungal pathogens."

Read the full letter here.

Barbara E. Murray, President, Infectious Diseases Society of America (IDSA):

"I write to express support for the Development an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act...This legislation would provide a new supplemental payment for certain antimicrobial drugs through the Medicare New Technology Add-on Payment (NTAP) program. Your bill acknowledges that we are in the midst of a public health crisis resulting from an increase in antimicrobial resistant infections and a market failure that is discouraging antimicrobial research and development (R&D)."

Read the full letter here.

Tom Inglesby, CEO & Director, UPMC Center for Health Security:

"Your DISARM Act has the potential to attract renewed research and development and help jump start the stalled out pathway for novel antimicrobial therapies that the public health badly requires. We applaud your commitment to reversing the alarming trend of antimicrobial resistance with this important legislation, and we look forward to working with you to solve this problem."

Read the full letter here.

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