LONDON, UK (GlobalData) - While the world focused on the fate of the Affordable Care Act, another important piece of healthcare legislation worked its way through Congress, the Prescription Drug User Fee Act (PDUFA) V. First introduced in 1992, PDUFA authorizes the FDA to collect fees from companies seeking approval of new drugs. The FDA uses these funds to hasten the drug review process. PDUFA must be approved every five years, and the fifth iteration has to be renewed by this October. PDUFA V has been approved by both houses of Congress and awaits President Obama's signature. As with most pieces of legislation, PDUFA V is multifaceted, but the Generating Antibiotic Incentives Now (GAIN) Act alone could dramatically influence the pharmaceutical industry.

The GAIN Act outlines enticements for pharmaceutical companies to develop novel antibiotics. Antibiotics have saved countless lives since their implementation in the 1940s, but the emergence of microorganisms that have developed antibiotic resistance has been an escalating medical concern. Drug-resistant infections are difficult to treat and have resulted in an increase in medical costs and mortality. Despite the escalating need for novel antibiotics, Big Pharma has been decreasing, or even eliminating, internal antibiotic R&D. The expensive, lengthy drug approval process, low price and short duration of antibiotic therapy, and competition from generics culminated in pharmaceutical companies shifting their focus to more profitable therapies (e.g. cancer and cholesterol therapeutics). The GAIN Act hopes to buck this trend by outlining various incentives meant to spur antibiotic drug discovery and approval to combat the various drug-resistant pathogens. These pathogens include Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Staphylococcus aureus (VRSA), Vancomycin-Resistant Enterococcus, Multidrug-Resistant Acinetobacter, Multidrug-Resistant Klebsiella, Multidrug-Resistant Pseudomonas, Multidrug-Resistant Escherichia coli (E. coli), Multidrug-Resistant Tuberculosis, and Clostridium difficile (C. diff).

Incentives outlined in the GAIN Act include:
1. Companies developing a novel antibiotic will be eligible for fast track status. This will increase the level of communication between the FDA and the company, decreasing the time required for filing a New Drug Application (NDA).
2. The novel antibiotic NDA would then qualify for priority review, thereby shortening the FDA review period from ten to six months.

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