Reviving the Pipeline of Life-Saving Antibiotics
Exploring Solutions to Spur Innovation
Antibiotic-resistant infections are a growing public health threat. At the same time, antibiotic innovation is waning. Howard Florey, the co-discoverer of penicillin, lived to see 13 new classes of these drugs make it through the pipeline. Since his death in 1968, however, there have been just two.
The Pew Health Group (Pew), the Infectious Diseases Society of America (IDSA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) hosted a one-day conference, Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation, at the offices of The Pew Charitable Trusts in Washington, DC, on September 22, 2011. About 100 attendees, including infectious diseases physicians, pharmacists, economists, pharmaceutical industry representatives, and government officials, explored ways to overcome the challenges that hinder the development of new antibiotics (drugs designed specifically to kill disease-causing bacteria, as opposed to viruses, fungi, and other pathogens).
The conference, moderated by Allan Coukell, director of medical programs at Pew, was divided into three sessions. During the first session, panelists identified the greatest unmet health needs requiring new antibiotics. The second session was aimed at addressing the current regulatory and scientific challenges that hinder antibiotic development. Throughout the third session, speakers and panelists examined economic incentives that could spur greater innovation.
Although the conference was not designed to generate consensus, some common themes emerged:
- Several factors make antibiotic research and development challenging, including drug resistance and the low return on investment compared with other therapeutic areas.
- The greatest immediate public health need is for antibiotics designed to treat infections caused by multidrug-resistant, Gram-negative bacteria, such as Escherichia coli, Pseudomonas aeruginosa, and Klebsiella pneumoniae.
- The U.S. Food and Drug Administration (FDA) should provide clearer guidance to industry about conducting antibiotic clinical trials (i.e., testing in humans), including feasible study designs.
- Faster diagnostic tests are needed to identify suitable patients for enrollment in antibiotic trials. New diagnostics can also guide proper usage of these drugs in clinical practice.
- Drug companies require better financial incentives to develop antibiotics, and a variety of potential policy solutions exist. Panelists emphasized that no single incentive is sufficient to address the multiple challenges impeding research and development.
Download the PDF for more information
- Date added:
- Apr 12, 2012
As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.More info
''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."More info
"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."More info
"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."More info