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The Honorable J. Phillip Gingrey
US House of Representatives
442 Cannon House Office Building
Washington, DC 20515-1011
Dear Representative Gingrey:
The American Society for Microbiology (ASM), the largest single life science Society with over 38,000 members, is pleased to comment on the “Generating Antibiotic Incentives Now (GAIN) Act” (HR 2182), introduced by you on June 15, 2011, and cosponsored by Representatives Gene Green, Ed Whitfield, Diana DeGette, Mike Rogers, Anna Eshoo, and John Shimkus of the House Energy and Commerce Committee. The ASM strongly agrees with the intent of the GAIN Act to provide greater incentives for research and development of antimicrobial products within the private sector.
The ASM has long been concerned about the shrinking industry pipeline of novel antimicrobial drugs and other products, which is exacerbated by drug resistance among microbial pathogens that renders current drugs ineffective. The ASM commends the sponsors of the GAIN Act for recognizing that additional incentives are needed to stimulate industry R&D of antimicrobial products. Unfortunately, infectious diseases persist as significant causes of illness and economic loss in the United States and worldwide. Increasingly, US citizens traveling abroad are acquiring life threatening infections due to multidrug resistant organisms. New diagnostics and therapeutics are indispensible in successful public health efforts to prevent, control, and treat infectious diseases.
Under the GAIN Act, amendments to the Federal Food, Drug, and Cosmetic Act would both expedite product approval processes by the Food and Drug Administration (FDA) and extend the periods of exclusivity given product developers. These targeted amendments specifically provide companies with greater incentives to develop “Qualified Infectious Disease Products” (QIDP), defined as a product for treating, detecting, preventing, or identifying a qualifying pathogen. The qualifying pathogens listed are microorganisms of great concern because of their lethality, including multi-drug resistant tuberculosis, methicillin-resistant Staphylococcus aureus, and multi-drug resistant Escherichia coli species. However, it is highly probable that the qualifying agents will change rapidly due to globalization, changes in healthcare, and other reasons, and we strongly believe that the organisms listed in the legislation be used as examples only.
The ASM agrees that fast track FDA product review and other expedited QIDP related processes, along with the extended exclusivity periods, should create industry incentives. The GAIN Act also correctly requires the Secretary of Health and Human Services (DHHS) to review the FDA guidelines for clinical trials with respect to antimicrobial drugs, to clarify and possibly revise industry requirements for product approval. However, this should be done with input from the Agency and leading scientists from both academia and industry.
The ASM also commends the GAIN Act’s request that the US Comptroller General conduct a study on the need for further industry incentives that stimulate R&D of QIDP products, reporting its results to the Congress along with recommendations on appropriate resolutions to the current shortages in the new product pipeline. In 2009, the Secretary of the DHHS called for a review of its Public Health Emergency Medical Countermeasures Enterprise by the National Biodefense Science Board and the Institute of Medicine. Careful consideration should be given to the findings of these studies. In addition, after 911 Congress attempted to engage industry about what it would take to involve them in development of countermeasures, including new antibiotics. Consideration should be given to the outcome of these discussions, reports and hearings. Even with the large incentives offered by the Biomedical Advanced Research and Development Authority (BARDA), the reviews mentioned above indicate a failure to engage industry in the development of new antibiotics. We believe that prior to granting extended exclusivity and priority review provided in the GAIN Act, there should be some assurance that these incentives will achieve the desired result.
We appreciate this opportunity to comment on the proposed GAIN Act and look forward to being of assistance to the House Committee on Energy and Commerce as it considers legislation to address infectious diseases and drug resistance.
David C. Hooper, M.D., President, ASM
Roberto Kolter, Ph.D., Chair, Public and Scientific Affairs Board
Gail H. Cassell, Ph.D., Chair, Committee on Biomedical Research
Stephen M. Ostroff, M.D., Chair, Committee on Public Health
The Honorable Gene Green
The Honorable Ed Whitfield
The Honorable Diana DeGette
The Honorable Mike Rogers
The Honorable Anna Eshoo
The Honorable John Shimkus