Infection Control & Hospital Epidemiology (2018), 39, 1499–1504 doi:10.1017/ice.2018.252
Letter to the Editor
The GAIN Act legislation to combat antimicrobial resistance: Where do we stand?
Maroun M. Sfeir1,2 1Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts and 2Department of Pathology, Harvard Medical School, Boston, Massachusetts
worldwide in several ways.3 It obliges the FDA to prioritize the communication and review processes for the sponsor of an eligible new antibiotic. It also grants an extra 5 years of market protection for newly qualified antimicrobials.3 The legislation also provides 6 more months of exclusivity if the sponsor identifies a companion diagnostic test. Between July 2012 and May 2018, a total of 20 new antimicrobial agents including antibiotics, antifungals, and monoclonal antibodies that target bacteria or fungi, have been approved by the FDA compared to 6 new agents for a 6-year period prior to the GAIN Act (Table 1). However, a 2-sample Student t test comparing the mean of number of antimicrobial agents approved 6 years before and after the Act failed to show a statistically significant difference in means, with a P value of 0.06 and a 95% confidence interval of −3.84 and 0.09. Yet there is a need to consider additional incentives that stimulate the development and approval of new antimicrobials. Advancements in antibiotic development are inherently chal-
To the Editor—Antibiotic resistance is one of the world’smost pressing public health problems.1 Per the Centers for Disease Control and Prevention, each year in the United States, at least 2 million people become infected with resistant bacteria and at least 23,000 die as a direct result of these infections.2 Anti- microbial resistance occurs as a natural process in which microbes evolve.1,2 Subsequently, we always need new anti- microbials to sustain with newly emerging resistant pathogens. The Generating Antibiotic Incentives Now (GAIN) Act was passed on July 9, 2012, as part of the Food and Drug Admin- istration (FDA) Safety and Innovation trying to encourage the pharmaceutical industries to return to a specialty that is in dire need of novel drugs.3 Here, I offer an assessment how the GAIN Act addresses barriers to new antibiotic development and to identify the gaps in the Act. The GAIN Act aims to incentivize antibiotic drug discovery
lenging, particularly relative to other therapeutic fields. And the price of antibiotics is often underappreciated compared with other drugs. A main reason is that the drugs pricing in the United States is not tied to the cost-effectiveness or the public health value of the medication. Additionally, infections occur more
Author for correspondence: Maroun Sfeir, MD, MPH,MS, Department of Pathology,
Clinical Microbiology Laboratories, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114. Email:
msfeir@mgh.harvard.edu
Cite this article: Sfeir MM, et al. (2018). The GAIN Act legislation to combat
antimicrobial resistance: Where do we stand? Infection Control & Hospital Epidemiology 2018, 39, 1499–1500. doi: 10.1017/ice.2018.252
© 2018 by The Society for Healthcare Epidemiology of America. All rights reserved.
frequently in developing countries with low insurance coverage where many patients cannot afford expensive antibacterial drugs.4,5 Consequently, pharmaceutical industries would rather invest in developing profitable therapeutic ventures (eg, antic- ancer drugs, which are very expensive and yet often extend a patient’s life only by months) than in developing new antibiotics, which are often used for a short duration, which may lead to unstable demand.6 Thus, a core incentive package (CIP) is necessary for rebalancing the antibiotics market and improving the net present value of antibiotic project development. This CIP must include both push and pull incentives.6,7 Push incentives focus on removing barriers to developer entry.6,7 That is largely accomplished by affecting the marginal cost of funds to the developer for investments in research and development by including tax credits and grants.6,7 These push incentives tend to impact the earlier stages of the drug development process. Meanwhile, pull incentives involve the promise of financial reward only after a technology has been developed.6,7 Pull incentives are largely responsible for funding and supporting the last stages of antibiotic development, including clinical trials, market approval, and commercialization.6,7 Large pharmaceutical industries particularly benefit from pull incentives which help guarantee a defined market for their product. Small and medium- sized enterprises can also benefit from pull incentives that pledge a future return and can help them secure venture capital to fund clinical trials.7 At present, few pull incentives are implemented in the
GAIN Act including the expedited FDA review process of the new antibiotics and the extended market exclusivity.3 How- ever, the Act misses major pull incentives, eg, antibiotics value- based pricing (VBP) and reimbursement plans, advanced market commitments, tax incentives that subsidies firms developing antibiotics, and large market entry rewards.3 Similarly, none of the push incentives which focus on long- term sustainable funding of basic science and preclinical research are tackled by the Act.3 Hence, incorporating into the Act the comprehensive CIP would create a robust competition among manufacturers of antimicrobials and generics and result in price competition. Furthermore, drug pricing is always a complicated process.
For pharmaceutical industries, it is important to make profit on the drugs sales because of the large investments needed to develop a new drug. However, due to the limited budget, and the rising proportion of health spending that is accounted for by pharmaceutical industries, it is important to investigate whether
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124
