[Ip-health] On GAIN ACT & Monopoly Protections on Antibiotics

Burcu Kilic bkilic at citizen.org
Wed Jun 20 09:51:58 PDT 2012

>From the American Medical Student Association:
"A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child's scratched knee could once again kill."
- Dr. Margaret Chan, Director-General, World Health Organization speaking of the growing global challenge of antibiotic resistance in Denmark in March 2012

In order to respond to this challenge of antibiotic resistance, existing antibiotics must be conserved and novel antibiotics developed. To preserve the effectiveness of antibiotics for human use, Europe banned feeding antibiotics to livestock for growth promotion in 2006. In Denmark, where such use of antibiotics had been phased out more than a decade ago, drug-resistant pathogens in livestock are down while industry output is up. Yet a bill to restrict such use here -- The Preservation of Antibiotics for Medical Treatment Act -- languishes in the U.S. Congress.

Instead, the Generating Antibiotic Incentives Now, or GAIN, Act has piggybacked into the FDA bill reauthorizing user fees for drug approval. GAIN would provide five more years of monopoly protections for new antibiotics. Already receiving three to seven years of exclusivity, some antibiotics may receive up to 10 years of protection after market approval. This measure defies both the economics and biology of antibiotic resistance.

These GAIN Act provisions, as written, will:
*         Further misalign economic incentives by encouraging firms to increase sales of their antibiotic under monopoly protection rather than to de-link the return on investment from volume-based sales. Other "pull mechanisms" like prizes buying out patents would have delinked the incentive given to drug firms. Extending monopoly protections does not directly address the scientific bottlenecks faced in the antibiotic pipeline.
*         Impose higher prices on consumers, but without any assurance of returns for such monopoly protections.  After all, designating "qualified infectious disease products" based on test-tube and animal studies does not mean there will be clinical benefit for humans, but waiting till phase 3 clinical trials providing such evidence would mean that firms had already committed to bringing that drug candidate to market, so an incentive would not be meaningful.
*         Risk targeting not only ineffective therapies, but also the wrong organisms. For example, the GAIN Act includes coverage of antifungal agents., which every first year medical student knows are not the same as antibacterial agents. The number of antifungal drug approvals for serious diseases has increased over the last decade, and antifungal drugs for serious diseases are prescribed for longer periods of time, often at significantly greater cost (and financial return) per patient. Incentives in the legislation should be limited to those areas in which they are needed, namely antibacterial drugs.
*         Risk bypassing important safeguards on conflict of interest in the approval process. Discussions of the FDA with "medical experts" outside the FDA should be done through the Federal Advisory Committee Act, with appropriate controls for conflicts of interest. Meetings with these experts should be conducted in an open, public forum through the FDA advisory committee process.

Sadly, the multiple alternatives that could address this issue are nowhere to be found in this bill. Amazingly, even Richard Bergstrom, director-general of the European Federation of Pharmaceutical Industries and Associations is quoted in the Wall Street Journal as saying: "We are not convinced that patent term extension, as is essentially the US proposal, will work in practice."
There is a cost to failing to take more meaningful steps to tackle antibiotic resistance. Already the costs of resistant infections to hospitals may reach as high as $4 billion annually. This is no time for complacency. Even with the GAIN Act's passage, this public health challenge will still remain: Tomorrow's infections will not be cured with this expensive placebo.

We cannot afford to waste time or resources in tackling the looming challenge of antibiotic resistance: we need to ask Congress to remove the GAIN Act from the FDA user fee bill. This bill would put the wrong economic incentives in place, putting pharmaceutical company profits over our patients. Please join us in sending a signal to policymakers and the public health community that we urgently must act to tackle this public health problem now with meaningful legislation, both to conserve existing antibiotics and to overcome the scientific bottlenecks in the antibiotic R&D pipeline.


  Anthony So and Robert Weissman, "Generating Antibiotic Incentives Now: GAIN or Just Greed," Huffington Post, July 6, 2012. Available at: http://www.huffingtonpost.com/anthony-so/antibiotic-resistance-_b_1572284.html.

 Public Citizen Letter to Senate on the GAIN Act provisions, April 9, 2012. Available at:  http://www.citizen.org/documents/2017.pdf

Anthony So, Quentin Ruiz-Esparza, Neha Gupta, and Otto Cars.  3Rs for innovating novel antibiotics: sharing resources, risks, and rewards. British Medical Journal 2012; 344(7852): 22. Available at: http://bmj.com/cgi/content/full/bmj.e1782?ijkey=TXeqN1NcCsPpzC1&keytype=ref

 Jean-Pierre Paccaud. Antibiotic drug research and development. British Medical Journal 2012; 344:e2591. Available at: http://www.bmj.com/content/344/bmj.e2591

Burcu Kilic, Ph.D.
Legal Counsel, Global Access to Medicines Program
Public Citizen | Protecting Health, Safety and Democracy
TEL: +1 202-588-7792
1600 20th St NW, Washington, DC 20009
URL: http://www.citizen.org/access
Twitter: @burcuno

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