By Paul G. Ambrose
The prevalence of hospital-acquired superbugs has reached an all-time high, claiming the lives of as many as 70,000 people per year. Yet, at the same time, drug development for new antimicrobial agents is at a historic low point. Recognizing the health risk posed by this disconnect, the World Health Organization and the Infectious Diseases Society of America unveiled separate strategic plans in April calling for increased surveillance of antibiotic-resistant microbes, more responsible use of existing antimicrobial medicines and incentives to create new drugs. But even with these calls to action, drug companies have been reluctant to make the large investments needed into antibiotic research and development (R&D) because of the high risk and low return compared to drugs for other diseases.
In an effort to change the R&D calculus, on 15 June lawmakers led by US representative Phil Gingrey, a Georgia Republican and a physician, reintroduced legislation called the Generating Antibiotic Incentives Now (GAIN) Act. The bill, which failed to pass when it was first proposed in September 2010, aims to grant speedier application reviews from the US Food and Drug Administration (FDA) for certain experimental treatments against infectious disease, and, if the drugs are licensed, extend marketing exclusivity by an additional five years (on top of the existing five). Together, these provisions ultimately result in more time for the drugmaker to benefit from its R&D investment.
Although the GAIN Act is a good first step to encouraging the development of new antimicrobial drugs, the bill’s current provisions won’t be enough to attract big pharma investment, nor will it assist smaller and more productive biotech companies that are often venture capital funded. The writing is already on the wall that the drug industry hasn’t been swayed by the proposed legislation. In February, for example, the largest pharmaceutical company in the world, New York–based Pfizer, announced that it was shuttering its antibacterial drug development unit in the US, even though the drugmaker knew that the GAIN Act was close to reintroduction and probable approval. Then, in April, a subsidiary of New Jersey’s Johnson & Johnson—the world’s number-two pharma firm—also decided to drop its antibiotic program.
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