Economic Model For Antibiotics Is Broken, AstraZeneca’s Rex Says
A better economic model for anti-infective research would include incentives to start antibiotic R&D, AstraZeneca exec John Rex tells ICAAC, and go beyond current initiatives that provide financial relief after a new antibiotic is developed.
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The biotech’s senior VP for infectious disease and vaccine R&D says prevention must be a part of fighting antimicrobial resistance, but moving the new approach into advanced trials first requires getting a handle on the incidence of hospital-acquired pneumonia in intensive care patients.
FDA asks groups how it can help ensure prescribing is limited for products approved under proposed new pathway, but several say, other than labeling, it may be out of the agency’s hands.
FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.