The House Energy and Commerce Committee's Subcommittee on Health is considering reauthorization of the Project BioShield Act, legislation passed in 2004 that is designed to spur companies into making countermeasures against a bioterrorist attack.
However, in testimony before the subcommittee today, Martin J. Blaser, MD, president of the Infectious Diseases Society of America (IDSA), emphasized a different threat, one that infectious diseases physicians witness every day: the burden of antimicrobial-resistant infections such as methicillin-resistant Staphylococcus aureus (MRSA).
"Antimicrobial resistant infections have created a 'silent epidemic' in communities and hospitals across the country," Dr. Blaser said, crippling and killing a growing number of otherwise-healthy people and driving up health care costs. To make matters worse, the pharmaceutical industry has lost interest in developing new antibiotics to fight these infections because they are not as profitable as drugs for chronic conditions such as heart disease. IDSA outlined this problem and proposed solutions in its July 2004 report, Bad Bugs, No Drugs: As Antibiotic Discovery Stagnates…A Public Health Crisis Brews.
Also, Dr. Blaser noted, "the impact of an influenza pandemic cannot be overstated." Even a mild pandemic would claim hundreds of thousands of lives and hundreds of billions of dollars. H5N1 is showing ominous signs of becoming a pandemic strain, and despite increased attention to the problem, Dr. Blaser said, "the Institute of Medicine and virtually all experts conclude that the United States is woefully unprepared" for a flu pandemic.
By tackling these naturally occurring threats, Dr. Blaser said, the infectious diseases community will be better prepared for bioterrorism. "There is an inextricably linked, synergistic relationship between the research and development (R&D) needed to protect against both naturally occurring infections and bioterrorism agents," he said. "Research in both areas seeks to understand how these organisms cause disease, the immune system response to these pathogens, the development of drug resistance, and how antibodies and medicines protect against them."
Congress should acknowledge this when reauthorizing BioShield, he said. Appearing at a congressional briefing sponsored by Rep. Barbara Cubin (R-WY), Dr. Blaser noted that a bill she has introduced includes many of IDSA's recommendations to resolve problems in the antimicrobial and anti-infective market, as outlined in the Bad Bugs, No Drugs report. Among the recommendations included in Rep. Cubin's bill:
- Full restoration of patent terms to account for the time lost during FDA review of a qualified product.
- A tax credit for facilities used to manufacture or distribute, or for R&D on, a qualified product.
- Manufacturers of qualified products may take a tax credit on research expenses.
IDSA also supports several other steps to strengthen infectious diseases legislation, including:
- Granting a "priority review voucher" to a company that develops a qualified product. The company can use that voucher to speed FDA review of another product, or it could sell the voucher to another company.
- Extending the patent term on antibiotics and other anti-infectives--a controversial proposal, but one for which the time has come.
- Doubling CDC's antimicrobial resistance funding to $50 million in fiscal year 2007.
The need for new tools to fight infectious diseases is urgent. Antimicrobial resistance is growing, and many experts believe we are overdue for an influenza pandemic. Dr. Blaser concluded, "These bad bugs will not wait, and neither can we."