Impact on drug-resistant microbes would be a factor considered during the review of antimicrobial drug applications under legislation introduced in the House Sept. 27 by Reps. Jim Matheson, D-Utah, and Mike Ferguson, R-N.J.

Manufacturers of antimicrobials also would have to provide data on their drugs' use and might have to implement management strategies to address the issues raised as microbes lose their susceptibility to treatment by pharmaceuticals.

The Strategies to Address Antimicrobial Resistance Act., H.R. 3697, directs HHS to monitor antimicrobial resistance, develop strategies to combat resistance and identify research priorities.

The resistance of microorganisms to drugs is a "serious and life-threatening patient safety and public health problem," Matheson said in introducing STAAR.

Interagency Panel Would Aid In Drug Review

The bill calls for the drug review process for antimicrobials to assess a compound's effect on antimicrobial resistance and assigns this job to a federal interagency task force.

That panel also would make recommendations with regard to any potential benefits of an antimicrobial's approval, "as measured by substantial evidence from adequate and well-controlled trials." The new FDA Amendments Act requires the agency to issue guidance on antibiotic clinical trials by Sept. 27, 2008 (see ¹ Also see "Antibiotic Trial Standards To Be Revised By FDA Under Congressional Mandate" - Pink Sheet, 15 October, 2007.).

Antimicrobial management strategies from the task force should "increase appropriate use and mitigate unnecessary increases in ... resistance predicted to result from approval of the drug application."

The legislation does not specify elements of a mitigation strategy. Several years ago, FDA tried to control prescriptions through a proposed labeling rule for systemic antibiotics that said testing of the target pathogens should guide prescribing. The final rule included a milder statement about culture and susceptibility information in response to comments about doctors' reliance on experience to make prescribing decisions (² Also see "Antibacterial Final Rule Defers To Doctors; Labeling Will Emphasize Testing" - Pink Sheet, 10 February, 2003., p. 22).

Under the bill, antimicrobial sponsors would have to submit annual reports on the amount of their product sold or distributed in the U.S. This information would be used to support epidemiologic and microbiologic research. HHS would set the content and format for the data submissions and post summaries of the information on a website, in a manner "respectful of confidential business information."

New HHS Office Would Take Lead on Issue

To ensure there is a federal point man on the issue, the bill creates an Office of Antimicrobial Resistance in HHS with responsibility to update a public health action plan published in 2001 for dealing with antimicrobial resistance. The interagency task force would aid in that endeavor.

Other duties of OAR would be to assess patterns of emerging antimicrobial resistance and how they are affected by using antimicrobials in humans, animals and plants as well as prioritize human infectious diseases in need of new point-of-care and other diagnostics, drugs and vaccines.

OAR is to award grants for demonstration projects that assess the scope of antimicrobial resistance and gather information that can lead to quality measures for health care providers prescribing antimicrobials. Funding also would be available through grants or cooperative agreements in a number of research areas, including studies of new therapeutics and diagnostics.

STAAR would also create an antimicrobial resistance clinical research and public health network. At least 10 sites would be set up to track regional outbreaks of microbes resistant to treatment, facilitate research and serve as a clinical trials network.

Thus far, no action on the measure has been scheduled by the House Energy and Commerce Health Subcommittee.

The bill could serve as a vehicle for a provision stripped from FDAAA that would have allowed FDA to grant exclusivities to older drugs receiving new approvals. Removal of that provision was "a disastrous decision at a time when we are seeing a huge rise of antibiotic resistance in this country," Sen. Tom Coburn, R-Okla., commented during floor debate.

Matheson also is a sponsor of a bill introduced by Rep. Brian Baird, D-Wash., that would provide tax credits and other incentives for antibiotic research and development.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Antimicrobial Drug Reviews Would Need To Consider “Resistance” Under Bill

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