With the current pipeline of antibiotics in development insufficient to meet the growing threat of bacterial resistance, the U.S. Government Accountability Office (GAO) found that one of the biggest impediments to expanding the pipeline is a poor return on investment for drug companies due to the low prices of older generic antibiotics and a limited patient population. While Health and Human Services (HHS) and the Department of Defense have provided financial premarket incentives to support antibiotic R&D, more postmarket incentives are needed, the GAO said in a report on antibiotic resistance that was issued Wednesday. Unless HHS develops a strategy to further incentivize the developments of new treatments for drug-resistant infections and gets the authority and funding to implement them, “more drug companies may exit the antibiotic development sector, and the pipeline of new treatments may continue to decrease,” the GAO warned.
The FDA’s Center for Drug Evaluation and Research (CDER) Thursday posted a new manual of policies and procedures (MAPP), Collaborative Identification, Evaluation, and Resolution of a Newly Identified Safety Signal (NISS), which went into effect immediately. The MAPP explains NISS, the center’s new process for tracking and managing the resolution of postmarket drug safety signals. Along with the MAPP, CDER introduced the Lifecycle Signal Tracker (LiST) workflow tool to capture and manage all safety signals for marketed drugs. “LiST will provide accountability, flexibility and transparency across the drug lifecycle and support collaboration across CDER,” center Director Janet Woodcock said. Besides supporting CDER’s PDUFA VI commitment for timely and effective evaluation and communication of postmarket safety, the MAPP and LiST address recommendations made in the 2015 GAO report on drug safety and the FDA’s postapproval oversight.
Australia’s Therapeutic Goods Administration is now publishing both the active and nonactive ingredients of drugs and biologics in the online summaries posted to the Australian Register of Therapeutic Goods (ARTG). In the past, only active ingredients were listed in the ARTG summaries. The inclusion of nonactive ingredients will help “people make better-informed choices about the products they use,” the TGA said.