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The House Energy & Commerce Committee held a hearing regarding the growing alarm over antibiotic resistance and how to bring about new drug development. This, just one day after President Obama announced an executive order to create a new task force and action plan to battle the problem.
Committee Chair and Congressman Fred Upton said in his opening statement, “Make no mistake: we are losing effective antibiotic treatments because the pace of new and novel drug development has not kept up with these organisms’ ability to build resistance to the treatments available today.”
Antibiotic resistance comes about from continued exposure to the overuse of antibiotics. Bacteria and other pathogens then circumvent the antibiotics thus mutating and growing stronger. Much like if a man built a brick house against a cannon and the cannon knocked it down and the man built a house with more bricks and the cannon only could make a dent. Bacteria and other pathogens learn how to get around the treatments. Close to 2 million infections occur each year in the US and 23,000 deaths occur from resistant bacteria.
Director of the Center for drug Evaluation and Research at the FDA is Dr. Janet Woodcock who addressed the problem by bringing to light that the developing new antibacterial drugs is a major challenge. She said, “From a scientific standpoint, many patients with bacterial infections are often very sick and need to begin antibiotic therapy immediately. But enrolling a very sick patient in a clinical trial at the same time can be very difficult.”. In addition she pointed out that antibiotics are generally looked at as less profitable due to their low prices and short duration periods of application.
Dr. Woodcock continued, “The judicious use of antibacterial drugs is at odds with the traditional business models and marketing practices used by the pharmaceutical industry for other drug categories, and serves as just one more disincentive to investment in antibiotics.”. The Dr. also brought up the need for new business models for developing antibiotics that disassociate antibiotic drug sales with companies’ returns on investments or ROI.
Agreeing with Dr. Woodcock is Kenneth Hillan, CEO at biopharma company Achaogen Inc. He urged support for the DISARM Act (Developing an innovative Strategy for Animicrobial Resistant Microorganisms) which is supposedly going to reform reimbursement of antimicrobial products in hospitals by providing a value based pricing instead.
Hillan continued, “This would provide a powerful incentive. By providing separate reimbursement for qualifying antibiotics, the SISARM Act would provide manufacturers with the opportunity to price new antibiotics in a way that is commensurate with the value provided.”