October 1, 2007

Bad Bugs on the Run

Bad Bugs logo

The Society scored a victory recently on its “Bad Bugs, No Drugs” initiative (www.idsociety.org/badbugsnodrugs) when Congress reauthorized the Food and Drug Administration (FDA) Prescription Drug User Fee Act on Sept. 21. The new law includes several IDSA-backed provisions that would remove obstacles from antibiotic drug review and provide incentives to strengthen the drug pipeline.

Among other things, the law requires FDA to:

  1. establish and update clinical susceptibility concentrations—the breakpoints at which a bacterium is likely resistant to antibiotics
  2. hold a public meeting to discuss the eligibility of antibiotics for certain orphan drug incentives
  3. publish guidelines for anti-infective clinical trials by September 2008
  4. provide priority-review vouchers in exchange for drugs approved to treat tropical diseases

Unfortunately, lawmakers in the House of Representatives removed an IDSA-backed provision that would have granted new market exclusivity to some antibiotics. IDSA will continue to push for this incentive.

In another important development, the “Strategies To Address Antimicrobial Resistance” (STAAR) Act was introduced on Sept. 27 by Reps. Jim Matheson (D-UT) and Mike Ferguson (R-NJ). Co-sponsors include Reps. Tammy Baldwin (D-WI) and Henry Waxman (D-CA).

This IDSA-initiated bill would improve the nation’s capacity to control resistance by establishing a network of experts across the country to collaborate with the Centers for Disease Control and Prevention (CDC) and conduct regional monitoring of resistant organisms as they occur—a kind of “snapshot” to pick up on problems early.

Researchers in the network also would work with CDC and the National Institutes of Health to find ways to slow the development of resistance. They would test potential interventions and perhaps new drugs, diagnostics, and other products as they move through the pipeline.

The STAAR Act would create an advisory board of infectious diseases, public health, and veterinary experts to advise the federal government on reducing resistance.

It would create an Office of Antimicrobial Resistance in the Department of Health and Human Services to build upon existing efforts and to better coordinate, help plan, and guide the government’s response to resistance.

Read more about the new FDA law.

Find out more about the proposed STAAR Act.

For the latest data from CDC on methicillin-resistant Staphylococcus aureus, see Klevens RM, et al.  JAMA. 2007;298:1763-1771, http://jama.ama-assn.org/cgi/content/full/298/15/1763.

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