FDA's GAIN Act Lags Behind UK Antibiotic Research Efforts, Study Reveals

Despite the enactment of the Generating Antibiotic Incentives Now (GAIN) Act of 2012, the U.S. Food and Drug Administration (FDA) is still lagging behind the European Medicines Agency (EMA) in antibiotic research and development, according to research and consulting firm GlobalData.

Even though the FDA has incentivized research into new antibiotics with GAIN, the GlobalData report showed that the agency still needs to pick up the pace to keep up with progressive regulatory bodies like the EMA. According to the report, the EMA has shown "superior willingness to reform clinical trial design for novel antibiotics and provide guidance that prioritizes clinical feasibility."

In fact, the UK’s Chief Medical Officer Dame Sally Davies released the second part of her annual report in March 2014, which highlighted  the threat of antimicrobial resistance and infectious diseases.

The report noted that, while there have been new diseases discovered, there have been very few developments in the antibiotics field to address these continually evolving diseases.

What has the FDA GAINed so far?

Since taking effect, GAIN has seen its share of successes such as:

• Catalyzing investment from companies in the antibiotics business
• Reinvigorating a stagnant pipeline
• Expediting drug approvals, most recently that of two novel drugs, Sivextro and Dalvance

In addition, it has created discussions between drug companies and the FDA with the aim of improving clinical study designs that "incorporate more relevant endpoints and pragmatic inclusion and exclusion criteria.” Indeed, Marc C. Hansel, Ph.D., GlobalData’s Analyst covering Infectious Diseases, said since releasing its draft guidance for antibiotic development, the FDA has shown a willingness to "engage drug makers in the design of clinical trials for areas of high unmet medical need."

These improvements are all well and good, however GlobalData's research still found a number of unmet needs that still exist within the bacterial infectious diseases area, noting in particular a high demand for novel treatments for multidrug-resistant (MDR) gram-negative bacteria.

What's the FDA to do?

With a new group of superbugs now on the rise and antibiotic-resistant forms of Pseudomonas aeruginosa and Klebsiella pneumoniae plaguing hospitals, there's a lot of work that needs to be done.

Hansel added that the FDA needs to refine its practice to maintain and grow a robust antibiotic pipeline. It is also necessary, Hansel says, that the FDA become more flexible to encourage the targeting of dangerous pathogens and that the agency do more to further Big Pharma's research and development resources by maximizing its commercial viability.