Innovation Is the Key to a Healthy Future
As we reflect on 2016, recent events, such as the Zika virus outbreak, the presence of superbugs in the United States, and the US presidential election, will continue to have a profound impact on healthcare.
The Zika virus will continue to affect the lives of thousands of families for years to come. These families have had to cope with the heart-wrenching effects of an elusive, and sometimes deadly, virus that causes birth defects such as microcephaly and eye disorders. In adults, the virus has been linked to Guillain-Barré syndrome and other neurological complications.
In addition, US healthcare was shaken with the discovery—on US soil—of the presence of a superbug in the form of a strain of E. coli with a colistin-resistant MCR-1 gene. The discovery put a renewed focus on antibiotic stewardship to combat antibiotic resistance.
Innovation is sorely needed to fight these emerging diseases and the Big Business mindset of our new president might be the necessary change to focus on research and development. Arguably, part of President-elect Donald Trump’s campaign to “Make America Great Again” is the notion to “Make America Create Again,” with a look at a bygone era when America was a top producer in the manufacturing space. Any disrupter in the business field will tell you that focus on innovation is needed to stay current and keep the world moving forward. The world’s antibiotic pipeline has all but dried up, and although focusing on antibiotic stewardship programs will help to slow the advance of antibiotic resistance, new technologies are required to truly fight superbugs. Recent legislation to provide “push-and-pull” incentives will hopefully spark research and development for antibiotics.
The Generating Antibiotic Incentives Now (or GAIN) Act, enacted in 2012 by President Barack Obama, provides incentives for pharmaceutical companies toward the development of antibiotics through extra market protection for qualifying drugs, which are “antibacterial or antifungal drug[s] for human use intended to treat serious or life-threatening infections,” and was the start of working toward this innovation. The act also requires the US Food and Drug Administration (FDA) to provide updated or additional clinical trial guidance for pathogen-focused antibiotics and to update every five years a list of “qualifying pathogens” that are deemed a serious threat to public health. But more incentives are needed.
On the heels of the GAIN Act, legislation passed by Congress includes the 21st Century Cures Act, which, at press time, awaits President Obama’s signature. The bills included in this act, such as the Promise for Antibiotics and Therapeutics for Health Act, the Reinvigorating Antibiotic and Diagnostic Innovation Act, and the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act, target all stages of the drug development process and support more government-funded research. This act, if signed into law, would change how the FDA approves new drugs and medical devices that treat serious or life-threatening infections and create tax credits for both antibiotics and antifungals that treat these infections and rapid infectious disease diagnostics.
The Cures Act, if signed into law, could pave the way for the renewed sense of development in the field of antibiotics, giving hope to those who are suffering from drug-resistant infections or the side effects of antibiotics only used as a last-resort mechanism, and bringing with it a much-needed boost for companies in or on the edge of entering the drug development space.
In terms of the status of drug development, in this issue, we focus on the latest drug approvals for 2016, highlighting those that target infectious diseases and featuring what we have learned so far since the approval of the hepatitis C pan-genotypic, Epclusa. Additional articles turn the spotlight on why HIV and tuberculosis are still strong threats around the world and current action to address antibiotic-resistant infections.
If we have learned anything from 2016, it is that change is needed to keep Americans safe and healthy. Well, change is certainly on the horizon. Only time will tell if the ambitious ideas of a new government will come to pass.
Thanks for reading!