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The Focus Areas: IV. Product Development

New products are not being developed rapidly enough to address increasing microbial resistance. Needed products include not only new classes of antimicrobials able to kill otherwise resistant organisms, but also vaccines and anti-infective devices with the potential to prevent infections as well as improved diagnostic tools to aid in appropriate use of therapeutics. With respect to antimicrobial drugs, each new agent represents a major investment by a pharmaceutical company, which must shepherd the product through pre-clinical studies and clinical testing, followed by large and expensive clinical trials. Pharmaceutical companies may be reluctant to invest extensive resources in the development of drugs, such as those antimicrobials targeted to resistant organisms, which are often given for short time periods to small numbers of patients. Manufacturers are similarly concerned that appropriate use policies may limit sales and profits. On the other hand, when a drug is used widely, allowing recovery of costs and profitability, resistance may develop more rapidly and shorten the useful life of the drug.

Due to these economic realities – as well as to scientific limitations and a lag in the perception of a need for new agents – very few novel antimicrobial drugs have reached the market for several years. A major aim of this interagency effort is to work with the private sector to explore and test innovative ways to address these issues. Approaches to be considered include providing incentives (and overcoming disincentives) to promote and assist the development of important products to address AR.

Product development is also a very important issue for veterinary medicine and agriculture. U.S. agencies and private sector partners must intensify efforts to encourage the development and use of veterinary drugs and agricultural practices that are unlikely to stimulate resistance to important human drugs or spread resistant pathogens to humans. Again, increased attention also needs to be turned to strategies to prevent infections of animals (e.g., vaccines, changes in husbandry) and to the improved use of existing and new products.

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A. Issue: Researchers and drug manufacturers need to be better informed of current and projected gaps in the arsenal of antimicrobial drugs, vaccines, and diagnostics and of potential markets for these products.

1.Goal: Provide a systematic assessment of the current status and projected future needs for AR products.

a. Action Items

  1. TOP PRIORITY ACTION ITEM - Create an Interagency AR Product Development Working Group to identify and publicize priority public health needs in human and animal medicine for new AR products (e.g., innovative drugs, targeted spectrum antibiotics, point-of-care diagnostics, vaccines and other biologics, antiinfective medical devices, and disinfectants). The Working Group will take these steps:
    • Obtain input from stakeholders, including pharmaceutical companies, physicians, epidemiologists, and microbiologists, on which products are needed;
    • Involve experts in the nonmedical disciplines (e.g., engineering and remote sensing, etc.);
    • Model future resistance trends, product needs, and potential markets (particularly for novel and narrow spectrum uses), taking into account AR surveillance data and numbers of patients at high risk of developing drug resistant infections (e.g., increases in immunocompromised patients);
    • Evaluate current market incentives for the development of priority AR products (Related Action Item: Product Development #80);
    • Reassess AR product priorities on a regular basis;
    • Evaluate the availability of currently approved, critical products where shortages or potential for shortages exists and develop an approach to ensure that the supply of such products is adequate to meet public health needs; and
    • Communicate the information and priorities developed by the Workgroup to inform and allow coordination with planning and action efforts in research, prevention and control, and product development.
      Coordinators: FDA, USDA, CDC; Collaborators: NIH, AHRQ
      Timeline: Begin within one to two years

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B. Issue: Existing market incentives and regulatory processes may be insufficient to stimulate the development of certain priority AR products while fostering their appropriate use.

1. Goal: Investigate and act upon potential approaches for stimulating and speeding the entire AR product development process, from drug discovery through licensing.

a. Action Items

  1. TOP PRIORITY ACTION ITEM - Identify ways (e.g. financial and/or other incentives or investments) to promote the development and/or appropriate use of priority AR products, such as novel compounds and approaches, for human and veterinary medicine for which market incentives are inadequate.
    • This process should include consultation with outside stakeholders, economic consultants, and the AR Product Development Working Group (Related Action Item: Product Development #79).
    • All such proposals will require careful economic modeling and analysis. New approaches should be used on a trial basis for appropriate time periods and the costs and benefits of incentives used in these pilot programs should be monitored to assess the return on the public investment.
    • Similar incentives should be explored for ensuring adequate availability of existing products that meet critical public health needs but for which market incentives are inadequate to assure supply. (Related Action Item: Product Development #79).
      Coordinators: FDA, CDC; Collaborators: USDA, AHRQ
      Timeline: Begin within one to two years
  2. Consider, in consultation with academia and industry, whether government has a constructive role to play in discovery of drugs and other products targeted to address areas where market incentives are limited and unmet needs exist (e.g., novel antimicrobial drugs targeted to specific resistant organisms). (Related Action Items: Research Issue B)
    • Such a role could utilize intramural, extramural or partnership type mechanisms. Products developed under such mechanisms could be licensed commercially either with or without specific stipulations regarding use.
      Coordinator: NIH; Collaborators: USDA, FDA, CDC
      Timeline: Begin within three to five years
  3. Continue ongoing approaches that streamline the regulatory process, including clinical trials and enhanced pre-clinical studies (e.g., use of pharmacokinetics, and pharmacodynamics data) to help bring AR products (including drugs, vaccines, diagnostics and devices) to market as efficiently and rapidly as possible, while still assuring their safety and efficacy.
    • This approach might involve use of an expedited process in which certain drugs are considered for approval, in accordance with Subpart E of the Investigational New Drug (IND) regulations. It might also involve defining new surrogate endpoints that indicate a meaningful response benefit over existing treatments for particular infections (e.g., HIV-1 RNA viral loads or CD4 counts as surrogate markers in the treatment of HIV/AIDS), in accordance with Subpart H of New Drug Application (NDA) regulations.
    • In the case of approvals for anti-infective medical devices, AR concerns will be addressed during the pre-and post-licensing review, to ensure that these products reduce infection without engendering significant resistance.
    • For products specifically targeted to serious or life-threatening AR infections, for which there are few therapeutic alternatives, develop approaches for more focused development programs that would streamline product availability. This should be done in consultation with all of the stakeholders in the process.
      Coordinator: FDA; Collaborator: USDA
      Timeline: Initiated

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C. Issue: The development and use of antimicrobial drugs and related products in agriculture and veterinary medicine should be optimized to reduce the development and transfer of resistance to pathogens that can infect humans.

1. Goal: Promote the development and use of new and existing AR products that reduce the risk of the development and transfer of antimicrobial resistance to humans, as well as new approaches to reducing agricultural and veterinary use of antimicrobial drugs.

a. Action Items

  1. In consultation with stakeholders and expert consultants, identify ways to promote the development of new and alternative veterinary treatments and the improved use of existing therapies that are unlikely to stimulate resistance to drugs in human medicine. This action will include consideration of the incentives and approaches listed in Action Items #80 (Product Development), #28 (Prevention and Control), and #78 (Research) and the implementation of pilot programs to stimulate the development of priority products that meet critical animal health needs.
    • Approaches for evaluation should include ways to improve and/or reduce the use of specific antimicrobial drugs, as well as ways to prevent infection, such as vaccines, changes in animal husbandry, and the use of competitive exclusion products (e.g., treatments that affect the intestinal flora of food animals).
      Coordinators: FDA, USDA, NIH, CDC
      Timeline: Begin within three to five years
  2. Streamline the regulatory and approval process for veterinary antimicrobial drugs and related products that are unlikely, now or in the future, to result in transfer of antimicrobial resistance to humans.
    Coordinators: FDA, USDA
    Timeline: Begin within three to five years

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