Antimicrobial Resistance

June 10, 2014 - ASM Signs onto a Letter Regarding the 21st Century Cures Initiative and the Antibiotic Development to Advance Patient Treatment (ADAPT) Act
The ASM joined 23 other organizations in signing a letter to the House Energy & Commerce Committee urging them to act promptly on the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which would carry out the PCAST recommendation to establish a new limited population approval pathway for antibiotics to treat serious or life-threatening infections where an unmet medical need exists.

April 18, 2014 – ASM Signs onto Letter Urging Support for Antibiotic Resistance Initiative
ASM joined 26 other organizations in signing a letter to the Chairs and Ranking Members of the House and Senate Appropriations Committee on Labor, HHS and Education.  The letter urged them to appropriate the $30 million included in the Fiscal Year 2015 President’s Budget Request for the Centers for Disease Control and Prevention (CDC) Detect and Protect Against Antibiotic Resistance Initiative.

June 7, 2013 - ASM Signs Onto Letter Regarding the Reintroduction of the “Strategies to Address Antimicrobial Resistance (STAAR) Act”
The ASM signed onto a letter to Representative James Matheson (D-UT) thanking him for reintroducing the STAAR Act.  The intent of the STAAR Act is to develop appropriate responses to the urgent problem of antimicrobial resistance.  Antimicrobial resistant infections affect hundreds of thousands of Americans and cause tens of thousands of deaths each year.

April 30, 2013ASM Congressional Briefing - The Perpetual Challenge of Infectious Diseases: New and Emerging and Antimicrobial Resistance

November 13, 2012 - ASM Supports Antibiotic Action Initiative
In 2011, the American Society for Microbiology (ASM) was one of the first societies to support the Antibiotic Action initiative of the British Society of Antimicrobial Chemotherapy.  This initiative is now 12 months old and is raising awareness of the need for new antibiotics.  ASM members can sign an online petition for Antibiotic Action to demonstrate the need for new antibiotics. This petition is being used to encourage policy makers to support antibacterial drug discovery, research and development. To sign the petition, go to Antibiotic Action website at: http://antibiotic-action.com/.

April 13, 2011 - FDA Guidance for Industry on Judicious Use of Antimicrobial Drugs in Animals
The Food and Drug Administration (FDA) announced the publication of three documents in the April 13 Federal Register that are intended to phase out the use of antibiotics for growth promotion in food-producing animals. 

September 22, 2011 - New Report on Antimicrobial Resistance Published
The Transatlantic Taskforce on Antimicrobial Resistance has finalized its report, Recommendations for future collaboration between the U.S. and EU. The report presents 17 recommendations for future cooperation between the United States and the European Union in the global fight to keep antimicrobials effective. The recommendations address collaboration in the areas of appropriate use of antimicrobial drugs in human and veterinary medicine, prevention of drug-resistant infections, and strategies for improving the pipeline of new antimicrobial drugs. In addition, the report also presents a list of major ongoing activities being undertaken by the EU and the US which provide opportunities to learn from each other, point to areas of future collaboration and highlight novel and highly successful projects.

ASM Statements and Coalition Letters

July 12, 2012 - ASM Comments on FDA Draft Guidance for Industry
The ASM submitted comments to the Food and Drug Administration on two Guidance Documents for Industry, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" and "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI."

April 12, 2012 - ASM Cosigns Letter in Support of the Limited Population Antibacterial Drug (LPAD) Proposal
The ASM cosigned a April 12 letter to Congress, prepared by the Infectious Diseases Society of American (IDSA), urge Congress to establish a new antibacterial drug approval pathway as part of the upcoming Prescription Drug User Fee Act (PDUFA) legislation.

February 22, 2012 - ASM Cosigns Letter on Antibiotics Pipeline
The ASM cosigned a February 22 letter to Congress, prepared by the Infectious Diseases Society of America (IDSA), which urges the legislators to address the serious and growing problems of antimicrobial resistance and the dry pipeline for antibiotic research and development in upcoming Food and Drug Administration user fee legislation. The letter also asked Congress to incentivize the development of new related diagnostics and to strengthen federal efforts to promote appropriate use of antibiotics. (Senate Version)

February 22, 2012 - ASM Signs Coalition Letters to House and Senate Leadership About Antimicrobial Resistance
The ASM signed onto a letter sent to the House and Senate leadership regarding antimicrobial resistance and the dry pipeline for antibiotic research and development. 

January 25, 2012 - ASM Comments on FDA Cephalosporin Rule
The ASM submitted comments to the Food and Drug Administration on the rule on prudent use of antimicrobial drugs in food animals.

July 1, 2011 - ASM Comments on the GAIN Act
ASM sent a letter commenting on the Generating Antibiotic Incentives Now (GAIN) Act (HR 2182).

April 15, 2011 - ASM Comments on Public Health Action Plan to Combat Antimicrobial Resistance
The ASM submitted comments to the Centers for Disease Control and Prevention on the Public Health Action Plan to Combat Antimicrobial Resistance.

August 20, 2010 - ASM Comments on the FDA Draft Guidance on Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
The ASM submitted comments to the Food and Drug Administration (FDA) on the June 29, 2010 Federal Register Notice, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals."

August 17, 2010 – ASM Submits Comments on “Multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR) bacteria in healthcare settings. Expert proposal for a standardized international terminology."
ASM’s Committees on Laboratory Practices and Professional Affairs submitted comments to the European Centre for Disease Prevention and Control on its draft document, “Multidrug-resistant (MDR), extensively drug-resistant (XDR) and pandrug-resistant (PDR) bacteria in healthcare settings. Expert proposal for a standardized international terminology.”

June 7, 2010 - ASM Comments on Antimicrobial Resistance
The ASM provided comments to the Department of Health and Human Services Trans-Atlantic Task Force on Antimicrobial Resistance at its June 7 stakeholder Listening Session.

November 28, 2007 - ASM Sends Letter Regarding Antimicrobial Resistance Legislation
The ASM sent a letter to Representatives Jim Matheson (D-UT) and Mike Ferguson (R-NJ) and Senators Sherrod Brown (D-OH), Orrin Hatch (R-UT) and Richard Durbin (D-IL) regarding the legislation "Strategies to Address Antimicrobial Resistance Act (STAAR)" (HR 3697, S. 2313).

May 8, 2007 - ASM Letter Supporting Antibiotic Access and Innovation Amendment
The ASM sent a letter to Senator Orrin Hatch (R-UT) supporting an amendment he offered during floor consideration of the Food and Drug Administration Revitalization Act (S 1082). The amendment, Antibiotic Access and Innovation, would encourage the development of new antibiotics and improve the treatment of patients with infectious diseases.

January 5, 2007 - ASM Letter to the Food and Drug Administration (FDA) Regarding Antimicrobial Susceptibility Breakpoints
The ASM sent a letter to the Food and Drug Administration (FDA)in support of a Citizen Petition filed by the Clinical Laboratory Standards Institute (CLSI) regarding antimicrobial susceptibility breakpoints

June 19, 2002 - Preservation of Antibiotics for Human Treatment Act of 2002
On June 15, 2002 ASM sent comments to Representative Sherrod Brown (D-OH) regarding the Preservation of Antibiotics for Human Treatment Act of 2002.

April 3, 2002 - FDA Guidance Document on the Effects of Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal Flora
On March 27, the ASM's Committee on Agriculture and Food Microbiology submitted comments to the Food and Drug Administration in response to the agency's draft guidance for industry, "Assessment of the Effects of Antimicrobial Drug Residues From Food of Animal Origin on the Human Intestinal Flora," published December 27, 2001, in the Federal Register.

June 28, 2001 - Funding to Combat Antimicrobial Resistance
ASM sent a letter to Representative Sherrod Brown (D-OH) in support of his bill, "The Antimicrobial Resistance Prevention Act of 2001" which would provide funding for the coordinated efforts of federal agencies, including the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, the Department of Agriculture and others, to combat antimicrobial resistance.

August 1, 2000 - Draft Public Health Action Plan to Combat Antimicrobial Resistance
The ASM submitted comments to the Centers for Disease Control and Prevention on the Action Plan to Combat Antimicrobial Resistance.

April 8, 1999 -Antimicrobial New Animal Drugs Intended for Use in Food Producing Animals
The ASM submitted comments on the FDA "Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals."

December 14, 1998 - Congressional Round Table Discussion on Antibiotic Resistance
Dr. Gail Cassell, Chair of the Public and Scientific Affairs Board presented a statement and participated in a round table on antibiotic resistance convened by Senators Frist and Kennedy.

December 7, 1998 - Use of Antibiotic Resistance Marker Genes in Transgenic Plants
The ASM submitted a statement to the Food and Drug Administration regarding the draft guidance for industry, "Use of Antibiotic Resistant Marker Genes in Transgenic Plants: Report and Guidance for Industry."

September 5, 1996 - Notice of Filing of Gentamicin Sulfate Petition
The ASM sent a letter to EPA opposing a petition to allow gentamicin sulfate residue on apples. ASM is concerned about the potential for antibiotic resistance if gentamicin sulfate, an antibiotic used in human medicine, is used in agriculture.

July 31, 1996 - Extralabel Drug Use in Animals
The ASM submitted comments in response to FDA's proposed rule - Extralabel Drug Use in Animals. The ASM recommended that antimicrobial drugs that are essential in human medicine, such as fluoroquinolones and glycopeptides, be added to a list of agents who extralabel use is prohibited in animals.

Regulations

October 13, 2000 - Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use
The Food and Drug Administration (FDA) proposed September 19 that all systemic antibacterial drug products intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. Over-prescribing and inappropriate use of antibiotics have contributed to a dramatic increase in drug-resistant bacterial infections. The proposal is intended to encourage physicians to prescribe systemic antibiotics only when clinically necessary. It also encourages physicians to counsel their patients on the importance of taking them exactly as directed. A final rule based on this proposal would become effective one year after the date of its publication in the Federal Register. After that date, all systemic antibacterial new drugs and generic drugs (including drugs that have already been approved and are currently on the market) would have to comply with the labeling requirement.

Federal Agency Resources

ASM Report

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Report of the ASM Task Force on Antibiotic Resistance

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