3. Once approved, the antibiotic would receive five additional years of market exclusivity.

These carrots will not be large enough to entice Big Pharma to revive its antibiotic R&D, but they could increase interest in smaller companies with novel antibiotic pipelines. Examples of leading biotechnology companies with promising antibiotics are listed in the table attached. The GAIN Act acknowledges the need for novel antibiotics, but does little to address the underlying issues affecting drug discovery and antibiotic drug resistance.

Pharmaceutical companies decreased antibiotic discovery due to a low ROI. The incentives outlined in the GAIN Act do little to truly increase the profitability of antibiotics. While the FDA review process is hastened, the GAIN Act does nothing to increase the chance of approval for a given antibiotic candidate. Therefore, there is still considerable risk associated with antibiotic drug discovery. Big Pharma had shifted this risk to smaller firms, which has provided a short-term fix. Collaboration between public and private sectors would provide a more viable long-term solution for fostering antibiotic drug discovery. Establishing partnerships between academia and industry would reduce cost, increase access to compound libraries, and broaden expertise associated with antibiotic drug discovery. The GAIN Act also does nothing to prevent the spread or emergence of drug-resistant organisms. Without the implementation of antibiotic stewardship and surveillance, any novel antibiotics developed as a result of the GAIN Act will only provide temporary relief before microbes develop resistance.
Ultimately, the GAIN Act represents a stopgap solution. Establishing a pricing incentive that reflects the high cost associated with bringing a drug to market would increase the profitability of antibiotics. Changing the FDA safety threshold for antibiotics to align closer to other life-threatening indications (e.g. cancer) would decrease review time and cost, increase the probability of FDA approval, and enable doctors and patients to assess risks when treating a deadly, drug-resistant infection. Without lasting reform like the aforementioned examples, the need for antibiotics will only escalate, and Big Pharma will continue to pursue more profitable therapeutic avenues.

-NOTES TO EDITORS-

*Despite Lofty Goals, Generating Antibiotic Incentives Now (GAIN) Act Falls Short

This expert insight was written by GlobalData infectious disease analyst, Dr Brad Tebbets. If you would like an analyst comment or to arrange an interview, please contact us on the details below.

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