September 30, 2015
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1. European biopharmaceutical companies call for incentives, similar to those sought by US industry, for antibiotic R&D
The Biotechs of Europe innovating in Anti-Microbial Resistance (BEAM Alliance), a group of 40 small and medium European biopharmaceutical companies, released its position paper on proposals to reinvigorate antimicrobial investment and R&D on September 30th. Within this paper, BEAM outlines three short-term actions to be implemented immediately and one longer term strategy. The three short-term actions include creating a specific fund to finance early clinical development (preclinical up to phase II studies) of antibiotics for small and medium companies, expansion of various market incentives to increase the return on investment for antimicrobial drug development, and acceleration of regulatory approval pathways within the European Medicines Agency of products combatting antimicrobial resistance. BEAM further calls for the expansion of specific market incentives including tax breaks, market exclusivity extension, and higher prices meant to reflect the collective value of new antibiotics to patients and society. The alliance lauds similar initiatives enacted in the U.S. including the Generating Antibiotics Incentives Now (GAIN) Act, which implemented an additional 5 years of market exclusivity for antibiotics. The pharmaceutical industry has voiced its support for both the GAIN Act and a new US Congressional bill calling for tax breaks for antibiotic development, the Reinvigorating Antibiotic and Diagnostic Innovation Act.

BEAM's recommendations also echo provisions in the U.S. 21st Century Cures Act, passed by the House of Representatives and awaiting a Senate vote this fall. The bill includes a section incorporating proposals from the Antibiotic Development to Advance Patient Treatment (ADAPT) Act that would lower the regulatory standards for FDA approval of antibiotics. For instance, ADAPT would allow for animal and laboratory studies as well as pharmacokinetic data to be accepted as sufficient evidence for FDA approval. Physicians and advocates have
expressed concerns that the 21st Century Cures Act would undermine the FDA’s role in ensuring safety and efficacy in the drug approval process.
2. New report shows alarming global trends in antibiotic resistance 
CDDEP State of the World's AntibioticsThe Center for Disease Dynamics, Economics & Policy (CDDEP) released a comprehensive report on global antibiotic resistance (ABR) and use in humans, livestock, and the environment entitled "State of the World's Antibiotics." The report presents alarming findings about increasing rates of resistance to last-resort antibiotics in bacteria that can cause life-threatening infections. Though high-income countries continue to use far more antibiotics per-capita, antibiotic use is rising rapidly in middle-income countries, especially China, India, Brazil, and South Africa. In these countries, increased prosperity and population growth drives demand for animal protein, leading farmers to transition to intensive agriculture with antibiotics given to animals. In these countries, antibiotics are often easy to acquire over-the-counter, further increasing human antibiotic use. The report predicts that livestock consumption of antibiotics, which far exceeds human use, will increase by 67% from around 63,200 tons in 2010 to 105,600 tons in 2030 - due to both increases in animal population and shifts to intensive farming. 

Low- and middle-income countries where surveillance data have become available are showing rising resistance trends. In India, 57% of infections caused by Klebsiella pneumoniae, a common hospital pathogenic bacteria, were resistant to carbapenems antibiotic in 2014, up from 29% in 2008. Carbapenems, a last-resort antibiotic, is effective against Klebsiella infections in 90% of cases in the US and over 95% of cases in most European countries. The report additionally found that E. coli resistance is high and rising for many drugs globally. Incidence of methicillin-resistant Staphylococcus aureus (MRSA) is rising in sub-Saharan Africa, India, Latin America, and Australia. MRSA incidence has started to decline in countries where stewardship programs have begun, such as in South Africa, Europe, and the US. The report also emphasizes that incentivizing new antibiotic development is not enough to combat ABR because this does nothing to address overuse in the food and healthcare systems, and many new drugs are currently more costly than low- and middle-income countries can afford. Drawing upon globally aggregated data available on CDDEP's interactive ResistanceMap, the report is intended to empower low- and middle-income countries to better understand ABR and take coordinated, evidence-based action. 
3. European Commission releases "Guidelines for Prudent Antimicrobial Use in Veterinary Medicine"
EU
The European Commission (EC) published non-binding guidelines on antimicrobial use intended for member state authorities, farmers, and veterinarians. Providing implementation strategies for principles from their 5-year action plan on AMR released in 2011, the guidelines represent a "One Health" approach to address the threats to human and animal health posed by antimicrobial resistance (AMR).
The guidelines emphasize the importance of avoiding prophylactic use of antibiotics. Veterinary approval is highlighted as a prerequisite to administration of antibiotics, especially those used in human medicine. The guidelines call on meat producers to avoid administering antimicrobials to groups of animals through feed and drinking water. In addition, the guidelines establish practical, species-specific approaches to ensure prudent use of antimicrobials in production of poultry, cattle, swine, pigs, rabbits, and fish. These recommendations include avoiding antimicrobial treatment of eggs or newborn animals, and improving ventilation and housing to reduce disease-promoting conditions. The guidelines call on member states to provide data, analyzed by species and age group, to the European Surveillance Veterinary Antimicrobial Consumption project to allow for harmonized monitoring across the European Union. Lastly, the EC guidelines urge countries to develop and implement national AMR strategies that are multisectoral in nature. 
4. CDC Calls for improved oversight of antibiotic use in nursing homes
Centers for Disease Control and Prevention (CDC) Director Tom Frieden recently issued a press release announcing new federal priorities to crack down on antibiotic use and oversight in nursing homes. The Centers for Medicare and Medicaid (CMS) have proposed a requirement for all nursing homes to develop antibiotic stewardship programs to regulate inappropriate administration of medications, an issue that plagues many long-term care facilities. These federal actions follow a study published last month in the New England Journal of Medicine, which found a significant association between high rates of antibiotic use in nursing homes and increased risk of antibiotic-related harms for residents of these high-use homes. According to the study, even residents who do not directly receive antibiotics are at an increased risk for experiencing antibiotic-related adverse effects. These effects include infection by C. difficile, allergic reactions, gastroenteritis, and colonization of resistant organisms which can lead to multidrug-resistant infections. Nursing home residents are particularly vulnerable to these adverse outcomes, as their age and other health complications make it difficult to recover from an infection.  Many of the antibiotic prescriptions in high-use nursing homes are unnecessary, with more than half of residents taking at least one antibiotic in a single year, and 25-75% of these prescriptions failing to meet clinical prescribing guidelines. 

The study is one of the first to call attention to the dangers of antibiotic overuse and misuse in nursing homes.  Many U.S. hospitals and acute care clinics have integrated antibiotic stewardship programs into their review processes, but this has not been the case for most nursing homes. The CDC is taking the lead on ensuring that these long-term care facilities initiate or expand upon stewardship practices with its publication of the
Core Elements of Antibiotic Stewardship for Nursing Homes. This guide provides a practical stepwise program for improving antibiotic oversight in nursing homes, incorporating the following core actions: 
  • Leadership commitment: Demonstrate commitment to safe and appropriate antibiotic use
  • Accountability: Identify leaders who are responsible for overseeing antibiotic stewardship activities 
  • Drug expertise: Establish access to experts with experience or training in improving antibiotic use
  • Action: Take at least one new action to improve the way antibiotics are used in the facility
  • Tracking: Measure antibiotic use and adverse complications in the facility
  • Reporting: Share information with healthcare providers and staff about antibiotic use and outcomes
  • Education: Provide resources to healthcare providers, nursing staff, residents and families to learn about antibiotic resistance and opportunities for improving antibiotic use.”
5. New report rates top U.S. restaurant chains on antibiotic policies & practices
Chain Reaction

On September 15, a coalition of public interest groups led by the Natural Resources Defense Council (NRDC) and Friends of the Earth released Chain Reaction, a report evaluating the antibiotic use policies of America’s top fast food restaurant chains. Other contributors to the report included Keep Antibiotics Working, Consumers Union, the Center for Food Safety, and Food Animal Concerns Trust. Chain Reaction highlights the issue of routine administration of antibiotics to livestock and its contribution to growing levels of antimicrobial resistance.

The report includes a scorecard assessing the 25 largest U.S. fast food chains regarding their policies on antibiotic use and transparency in their meat and poultry supply chains. The scorecard was developed from targeted surveys of restaurants as well as public statements released by the chains. “Grades” were assigned based on the criteria of antibiotics use policies, implementation, and transparency. 

Of the 25 fast food chains, only 5 have adopted a policy to limit routine antibiotic use in their supply chains. Only 2 chains, Chipotle and Panera Bread, reported serving a majority of their meat produced without routine use of antibiotics. Popular chains including Subway, Starbucks, Burger King, and Olive Garden were among those that received a failing grade, largely due to the fact that these companies provide no public information on their policies regarding use of antibiotics in their meat products. 
 
The report was released in tandem with
a letter sent to the CEOs of top restaurant chains from 109 organizations representing the areas of public health, environment, and consumer interest. Letter signatories urged companies to:
  • Publicly commit to an antibiotics policy that prohibits the routine use of antibiotics in livestock growth other than in cases of treatment for sick animals; and 
  • Communicate with their meat and poultry suppliers to establish these expectations for a policy of antibiotics stewardship.
"This scorecard addresses a huge disconnect: consumers are concerned as never before about the health impacts of how their meat is produced, but the biggest actors in the marketplace by and large offer consumers little to no information that addresses those concerns," said David Wallinga, a physician at NRDC. "The scorecard therefore fills an important need - it lets consumers send the market a clear message around antibiotic resistance, voting with where they choose to eat and spend their food dollars."
6. FDA finalizes rules on food safety preventive controls for human and animal food
The US Food and Drug Administration (FDA) released the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food and Animal Food, which enacts stronger measures to prevent the 48 million foodborne illnesses that occur annually in the US. The rules require facilities to establish and monitor a written food safety plan with hazard analysis and preventive controls. The FDA can then evaluate these systems and their outcomes to more effectively prevent and respond to food safety problems. The rules also update FDA current good manufacturing practice (cGMP) regulations on manufacturing, processing, packing, and holding food.

Previous provisions involving education and training of employees are now binding. At the same time, flexibility has been built into implementation of supply chain programs. A facility is not required to have a supply chain safety program if the facility or another entity in the supply chain uses hazard preventive controls. In response to criticisms from the produce industry about the possibility of inconsistently exempting certain food producers, the FDA revised its definition of a "farm." The definition now includes "primary production farms," operations that grow and harvest crops and/or raise animals, and "secondary activities farms", which harvest, pack, and/or hold agricultural commodities. Under this definition, more farms are exempted from the preventive controls rule, though many fruit and vegetable farmers will not be exempted due to the Rule for Produce Safety, set to be finalized in October 2015.

The new rules have generally been praised by certain civil society organizations and industry groups. The National Sustainable Agriculture Coalition praised the revised definition of farms to account for the diversity in food producers. Meanwhile, the American Feed Industry Association praised the phase-in approach of the cGMP regulations. David Plunkett of the Center for Science in the Public Interest praised the rule, but expressed disappointment about the number of businesses exempted. In addition, the FDA has expressed concern about exemptions for vertically integrated animal feed mills, which meet the definition of a farm. With five more proposed rules to be finalized, the FSMA faces a funding shortage of $276 million that may create barriers to full implementation.
7. Announcement of public consultation on antimicrobial resistance rapid, Point-of-Care Diagnostic Test Challenge
BARDA Logo
The US Department of Health and Human Services (HHS) has announced a prize competition for delivery of rapid point-of-care diagnostics to identify bacterial infections. The prize will be up to $20 million, subject to the availability of funds. The National Institutes of Health (NIH) and the HHS Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition, with technical and regulatory assistance from the FDA and CDC.
The competition is intended to incentivize development of rapid diagnostics for resistant bacteria, as set forth in the March 2015 National Action Plan for Combating Antibiotic-Resistant Bacteria. Such diagnostics would guide healthcare providers in identifying infections, deciding whether to prescribe antibiotics, and choosing the appropriate antibiotic if such treatment is called for. Improved diagnostics could also facilitate clinical research on new antibacterial products. The NIH is currently seeking stakeholder comments on the technical criteria and performance characteristics of the diagnostics. A public consultation will be held on October 7, 2015 in San Diego, and written comments can be submitted from October 1st to 6th. 
8. The World Health Organization announces first World Antibiotic Awareness Week and new lead for AMR Secretariat
World Health OrganizationThe WHO World Health Organization has announced the first World Antibiotic Awareness Week, a campaign that will take place on November 16 to 22 to raise awareness about antibiotic resistance and encourage best practices among the public, healthcare professionals, and policymakers. The campaign, entitled "Antibiotics: Handle with Care," will convey the message that antibiotics are a valuable resource to be preserved. In particular, the WHO will emphasize that antibiotics should be used only for bacterial infections under prescription from a certified health professional. The campaign will also urge the importance of not sharing antibiotics and completing treatments rather than saving antibiotics for later use. The WHO will release resources to support the campaigns of member states and health partners.

The WHO has also appointed Dr. Marc Sprenger to the position of Director of the AMR Secretariat, who led the implementation on the recently adopted Global Action Plan on AMR. Prior to this position, Dr. Sprenger served as Director of the European Center for Disease Prevention and Control (ECDC) in Stockholm, Sweden. Before working at the ECDC, Dr. Sprenger also served as the Director-General of the National Institute for Public Health and Environment (RIVM) in Bilthoven, Netherlands. Dr. Sprenger has trained in both medicine and medical microbiology, also having received a PhD in epidemiology. He will lead the AMR Secretariat in coordinating the WHO’s technical assistance in implementing the global action plan.
9. The White House announces members of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
On September 15th, the U.S. Department of Health and Human Services (HHS), U.S. Department of Agriculture (USDA), and U.S. Department of Defense (DoD) announced the members and organizations of Presidential Advisory Council on Combating Antibiotic Resistant Bacteria. This multidisciplinary group from academia, industry, and other organizations will work on various efforts to combat antibiotic resistance. The members will provide recommendations policies and programs to ensure the continued efficacy of existing antibiotics, strengthen surveillance, prevent the transmission of antibiotic-resistant bacteria, advance new research, and improve coordination. This work will also complement other government initiatives including the National Action Plan for Combating Antibiotic-Resistance Bacteria and National Strategy for Combating Antibiotic Resistance. 

The council will be chaired by Dr. Martin J. Blaser, M.D. who is Director of the Human Microbiome Project and Professor of Microbiology at New York University School of Medicine. Previously, he served as President of the Infectious Disease Society of America, Chair of the Board of Scientific Counselors of the National Cancer Institute, Chair of the Advisory Board for Clinical Research of the National Institutes of Health, member of the Scientific Advisory Board of the Doris Duke Charitable Foundation and the Institute of Medicine. Other voting members of the Advisory Council include:
  • Lonnie J. King, D.V.M., M.S., M.P.A., A.C.V.P.M.; Dean, College of Veterinary Medicine, Executive Dean, Health Science Colleges, Ohio State University (Vice Chair)
  • Michael Apley, D.V.M., Ph.D., D.A.C.V.C.P.; Professor, Department of Clinical Sciences, Kansas State University College of Veterinary Medicine
  • Helen Boucher, M.D., F.A.C.P., F.I.D.S.A.; Director, Infectious Diseases Fellowship Program and Associate Professor of Medicine, Tufts University School of Medicine
  • Angela Caliendo, M.D., Ph.D., F.I.D.S.A.; Professor and Executive Vice Chair of Medicine and Director of the Division of General Internal Medicine, Alpert Medical School of Brown University
  • Alicia R. Cole; Founder, Alliance for Safety Awareness for Patients (ASAP)
  • Sara Cosgrove, M.D., M.S.; Director, Antimicrobial Stewardship Program, The Johns Hopkins Hospital, and Associate Professor of Medicine, Division of Infectious Diseases, Johns Hopkins University School of Medicine, and Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health
  • Peter Robert Davies, B.V.Sc., Ph.D.; Professor of Swine Health and Production, University of Minnesota
  • Kent E. Kester, M.D., F.A.C.P., F.I.D.S.A., F.A.S.T.M.H.; Vice President and Head, Translational Sciences and Biomarkers, Sanofi Pasteur
  • Ramanan Laxminarayan, Ph.D., M.P.H; Director and Senior Fellow, Center for Disease Dynamics, Economics and Policy
  • Aileen M. Marty, M.D., F.A.C.P.; Professor, Infectious Diseases, Department of Medicine, Family Medicine, and Community Health, Director, Health Travel Medicine Program and Vaccine Clinic, Florida International University
  • John H. Rex, M.D.; Senior Vice President and Head of Infection, Global Medicines Development, AstraZeneca Pharmaceuticals
  • Thomas R. Shryock, Ph.D.; Chief Scientific Officer and Managing Member, Antimicrobial Consultants L.L.C.
  • Randall Singer, D.V.M., M.P.V.M., Ph.D.; Professor of Epidemiology, Department of Veterinary and Biomedical Sciences, University of Minnesota
  • Robert A. Weinstein, M.D.; Former Chair, Department of Medicine, Cook County Health and Hospitals System, Chief Academic Officer, The C. Anderson Hedberg, M.D. Professor of Internal Medicine, Rush Medical College
Besides these members, the Advisory Council also includes non-voting representatives from various human and animal health organizations including:
  • National Pork Producers Council (NPPC)
  • National Association of Directors of Nursing Administration in Long Term Care (NADONA/LTC)
  • Animal Health Institute (AHI)
  • Association of State and Territorial Health Officials (ASTHO)
  • The Pew Charitable Trusts
In response to this announcement, Representative Louise Slaughter (D-NY) as well as other organizations and academic centers including the Natural Resources Defense Council (NRDC), Center for a Livable Future at Johns Hopkins Bloomberg School of Public Health, and Food Animals Concerns Trust released a statement expressing their concern that the selection of members to the Advisory Council is “unbalanced”. In this press release, the Congresswoman and organizations state that there is a lack of representation from groups engaged in efforts around the misuse of antibiotics in agriculture. Representative Slaughter also notes the number of representatives from both the pharmaceutical and agribusiness industries on the Advisory Council, creating a conflict of interest and favoring the routine use of antibiotics in agriculture. Others quoted in the statement further question the credibility of the Advisory Council should it continue to have inadequate representation of opposing opinions around the use of antibiotics in agriculture. The Advisory Council hosted its inaugural meeting on September 29, 2015, which was open to the public.
10. Nordic ministers in joint stance against antibiotic resistance
Flags of the Nordic Council
The Nordic Council, consisting of representatives from Denmark, Finland, Iceland, Norway, and Sweden, made a joint declaration early this month to pursue a One Health approach to antimicrobial resistance (AMR). The declaration agrees to strengthen Nordic collaboration to maintain a low level of AMR and prudent use of antimicrobials in the Nordic countries. Specifically, the declaration calls for the establishment of a "One Health" strategic group to support the exchange of best practices and efficient use of resources for AMR and antimicrobial consumption.
This group will have several roles. It will support national action plans on AMR and promote guidelines for hygiene, sanitation, and prevention. In particular, the One Health group will support antimicrobial surveillance and incentives to encourage prudent use. The declaration also emphasizes raising awareness and understanding about AMR. The declaration also commits the Nordic Council to support international cooperation on AMR with the EU, WHO, FAO, and OIE. This declaration comes as a follow-on action to The Future Nordic Co-operation on Health report, which identifies AMR as a key priority.
11. US Department of Health and Human Services begins partnership with AstraZeneca to develop new antibiotics
The US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) has entered into a partnership with biopharmaceutical company AstraZeneca to develop new antibiotics. As discussed in an HHS press release, this partnership will support development of a portfolio of drug candidates with dual uses in treating illness caused by bioterrorism agents and antibiotic-resistant infections. Though BARDA traditionally supports development of single products, developing multiple drug candidates increases the likelihood that one will advance to FDA market approval. The partnership involves a cost-sharing agreement to manage and fund this drug portfolio over the next 5 years. Initially, BARDA will provide $50 million towards product development, and may provide up to $170 million for development of additional products in the portfolio. The first candidate is ATM-AVI, a drug that combines the antibiotics Aztreonam and Avibactam. ATM-AVI is intended to expand the currently limited treatment options for Gram-negative bacterial infections. The European Union Innovative Medicines Initiative (IMI), a partnership between the EU and the European pharmaceutical industry, is supporting Phase 2 clinical studies of ATM-AVI under their COMBACTE-CARE project. The IMI will join BARDA and AstraZeneca in funding additional clinical studies needed for regulatory approval of ATM-AVI. This is the second partnership of this nature for BARDA, following a partnership on antibiotic development with GlaxoSmithKline that began in 2013. The BARDA-AstraZeneca partnership resulted from the US National Action Plan for Combating Antibiotic-Resistant Bacteria of March 2015, which included a recommendation that BARDA create at least one additional public-private partnership to develop new antibiotics.
Other Recent Developments in AMR
Food and Agriculture Organization adopts resolution on Antimicrobial Resistance
The Food and Agriculture Organization of the United Nations (FAO) passed a resolution in June 2015 on antimicrobial resistance. Recognizing the transmission of AMR between animals and humans in the food system and environment, the FAO resolution sets forth recommendations for member states. The resolution urges member states to increase political leadership on AMR to ensure access to antimicrobials through prudent agricultural use. The FAO recommends that member states strengthen AMR monitoring and support developing countries in developing AMR surveillance and management. The resolution calls for strengthening analysis and sharing of scientific evidence on AMR in food, agriculture, and the environment. The resolution further recommends increased awareness and information-sharing among stakeholders. To reduce the risk of disease and prevent unnecessary antimicrobial use, member states are asked to develop sustainable food systems that take into account social, economic, and environmental aspects. The FAO recommends that member states create or strengthen national strategies and international collaboration for surveillance and containment of AMR.
The resolution also encourages research and development for new antimicrobials and alternative therapies, and diagnostics to facilitate responsible antimicrobial use. With respect to FAO activities, the resolution requests that the organization provide capacity-building assistance for establishing sustainable production systems, increase tripartite collaboration with World Organization for Animal Health (OIE) and World Health Organization (WHO), explore with the UN Secretary-General options for high-level initiatives and meetings, and support implementation of the
WHO
Global Action Plan on Antimicrobial Resistance. Further information on FAO efforts against AMR can be found on their AMR theme page.
Researchers discover transient antibiotic resistance mechanism, indicating need for improved resistance testing
In a study published in EBioMedicine, researchers at the University of California Santa Barbara have discovered that bacteria may become temporarily antibiotic-resistant under conditions that simulate the intracellular environment of host organisms. Their finding calls into question current lab-based testing for antibiotic resistance, which uses growth media that may not be representative of the human body's cellular environments. The researchers found that Salmonella enterica Typhimurium exhibited antibiotic resistance when grown in mildly acidic conditions that mimic organelles within white blood cells where Salmonella resides. Under these conditions, Salmonella continued to grow in the presence polymyxin B, an antibiotic, at doses well above those used in existing lab tests for resistance. This effect was observed for some, but not all of the antibiotics tested. Similar tests using Yersinia pseudotuberculosis, an extracellular pathogen, showed that transient resistance was possible but under a different set of environmental conditions.

Taken together, the results for Salmonella and Yersinia suggest that a variety of bacterial species may have a mechanism for transient resistance. Transient antibiotic resistance is both rapid and rapidly reversible. This effect can allow bacterial populations to persist and then evolve permanent resistance through mutational mechanisms. These results suggest that resistance tests need to take into account the influence of the host's bodily microenvironment. Testing for resistance under host-conditions would help physicians avoid situations where patients have a persistent infection, but treatment with the same antibiotic is continued because a conventional test does not indicate resistance - which would then facilitate growth of resistant bacteria. More robust resistance testing of this nature would in turn aid the development of treatment guidelines.
Bipartisan legislation to incentivize antibiotic and diagnostic development introduced to US Congress with support from 40 groups
The Infectious Diseases Society of America circulated a sign-on letter to support bipartisan legislation that would provide tax credits for development of new antibiotics, antifungals, and rapid diagnostics. Introduced to Congress by Representatives Charles Boustany (R-LA) and Mike Thompson (D-CA) on September 17th, the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act of 2015 creates a "push" incentive that would reduce costs during the development stages. The READI Act tax credit would cover 50 percent of clinical testing expenses in phase 2 and 3 trials. Developing antibiotics comes with unique economic challenges because continued use of an antibiotic leads to resistance, making the drug ineffective. In addition, antibiotics typically have low prices and short use durations, making them less profitable than drugs such as those intended for chronic disease. The READI Act would complement the Generating Antibiotic Incentives Now (GAIN) Act, passed in 2012, which created a "pull" incentive by rewarding companies with 5 years of market exclusivity for bringing new antibiotics or antifungals to market. The letter expresses how the combination of push and pull incentives will most effectively stimulate development of new antibiotics in the face of infections that cannot be treated with existing drugs. A total of 40 groups signed the letter, showing broad international support for new antibiotic development incentives from civil society groups, pharmaceuticals, and professional societies.
New study finds antibacterial soap with triclosan no more effective than plain soap
According to a study published in the Journal of Antimicrobial Chemotherapy, researchers found that antibacterial soap containing triclosan was no more effective than plain soap at reducing bacterial contamination. Triclosan is one of the most common ingredients in antibacterial soaps. In response to a rule proposed by the FDA in 2013 to test the efficacy and safety of antibacterial soaps, the researchers tested 20 bacterial strains using 0.3% triclosan soap and plain soap at room and warm water temperatures to simulate typical hand-washing conditions. The study also tested antibacterial soap for human test subjects artificially inoculated with Serratia marcescens bacteria. This study adds to recent pushback against antibacterial soap, given evidence in previous studies suggesting triclosan can contribute to antibiotic resistance. The state of Minnesota passed a law in 2014 mandating the phase-out of triclosan containing soaps by 2017. This year, the US Food and Drug Administration (FDA) additionally proposed a rule this May to require that manufacturers provide additional in vitro and clinical data on the safety and antimicrobial properties of antiseptic ingredients.

Note: The ARC Newsletter will periodically capture key meetings and developments, as well as news and resources, on antibiotic resistance for Coalition members and partners. This newsletter is prepared and published through ReAct North America and the Program on Global Health and Technology Access at the Sanford School of Public Policy at Duke University. The ARC Declaration on Antibiotic Resistance can be found here. Please share items for consideration for inclusion in future newsletters by writing to Reshma Ramachandran at reshma.ramachandran@duke.edu.