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.
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The House Energy and Commerce Subcommittee on Oversight and Investigation held a hearing on Feb 16 entitled "Counterfeit Drugs: Fighting Illegal Supply Chains." Elizabeth Jungman, director of drug safety and innovation testified on counterfeit drugs the importance that newly passed Drug Quality and Security Act will have on the safety of the U.S. pharmaceutical supply chain.
The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform. More info
The Pew Charitable Trusts sent a letter to Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) of qualified support of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them most. The letter was also signed by 31 organizations representing healthcare providers, hospitals, pharmacists, clinical laboratory scientists and medical microbiologists, public health experts, patients and advocates. More info
On January 31, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act and addressed five topics: anticipatory and office stock compounding; quality standards; FDA / state coordination; MOUs to address inordinate interstate shipment of compounded drugs; use of bulk drug substances. More info
On Dec. 12, 2013, a bipartisan bill was introduced in the U.S. House of Representatives to encourage development of antibiotics for patients with serious or life-threatening bacterial infections. The new legislation would direct the U.S. Food and Drug Administration, or FDA, to approve new antibiotics and antifungal drugs for specific, limited populations of patients who have infections for which few or no suitable options exist. More info