Infectious Diseases Experts Urge Creation of "Bioshield II"

ALEXANDRIA, Va. -- The Infectious Diseases Society of America (IDSA) today called for a "Bioshield II" initiative to spur research and development (R&D) of new antibiotics and other drugs to address the threat posed by drug-resistant organisms and other naturally occurring infections.

This week, Congress passed legislation commonly referred to as "Project Bioshield," in the National Defense Authorization Act for FY 2004. "Project Bioshield" authorizes the government to fund private sector R&D of biodefense products and to purchase those products to protect the military against bioterrorism. Bioshield I also allows the Food and Drug Administration (FDA) to waive certain requirements for manufacturing, processing, packing or holding of bioterrorism defense products to be used by the military.

"Project Bioshield will better prepare the United States against bioterrorism and is a first step forward in keeping Americans safe," said IDSA president Joseph R. Dalovisio, MD. "But more action is needed to protect the general public against naturally occurring infections," he added.

In a recent letter to FDA Commissioner Mark McClellan, IDSA urged the federal government to demonstrate similar urgency and leadership in spurring the development of new antibacterial drugs to treat infectious disease-related public health threats that are not linked to bioterrorism. The Society is particularly concerned about the increasing number of bacteria that are becoming resistant to approved antibiotics.

"There simply aren't enough new drugs in the pharmaceutical pipeline to keep pace with these 'superbugs,'" Dalovisio said. To address the growing crisis, Dalovisio called upon McClellan and other policymakers in the administration and Congress to move quickly to create a "Project Bioshield II" to cover new drugs that treat so-called superbugs.

Infectious disease experts are especially alarmed because many U.S. pharmaceutical companies are withdrawing completely from, or substantively reducing, their commitment to antibacterial R&D. Antibacterials do not stimulate the level of profits that drug manufacturers receive for drugs used to treat chronic diseases, and so many companies are aggressively focusing on developing the latter.

"Novel policy is needed now and, specifically, the creation of appropriate incentives to lure industry back to antibacterial R&D," Dalovisio said. "Immediate action must occur before the number of infections due to resistant organisms reaches epidemic proportions in hospitals and communities across the United States."

In its letter to FDA, IDSA also identified potential obstacles in the antibacterial review process and called for several changes to make FDA's review process more efficient for these drugs, while maintaining high standards for safety and effectiveness.

The antimicrobial resistance problem is severe and affects a wide range of people. Infectious disease physicians see diverse patients-athletes, business executives, patients young and old, previously healthy and chronically ill-who face lengthy hospitalizations, painful courses of treatment and even death due to drug-resistant infections.

According John G. Bartlett, MD, chair of IDSA's Task Force on Antimicrobial Availability, "It is clearly a case of 'bad bugs and no drugs,' and patients are the ones who will suffer as a result of the lack of urgency the federal government has shown this emerging public health crisis."

The Infectious Diseases Society of America (IDSA), based in Alexandria, Va., is a professional society representing more than 7,500 physicians and scientists who specialize in infectious diseases.

Source: IDSA