As you may have experienced for yourself, some physicians can be quick to prescribe antibiotics to their patients for a wide variety and (sometimes unnecessary) number of reasons. In cases where the patient has presented with a viral infection, such as the common cold, a prescription for an antibiotic is unlikely to be the solution; the vast majority of antibiotics are used to treat bacterial infections, not viral infections.

To complicate matters further, recent trends have shown that some physicians are prescribing the same antibiotics over and over again. The widespread inappropriate use of the same antibiotics can result in the formation of ‘superbugs’ such as the deadly Methicillin-Resistant Staphylococcus Aureus (MRSA) pathogen. These superbugs have become resistant to the most commonly prescribed antibiotics, resulting in what could be a grim outlook for the treatment of infectious diseases. This in itself creates a further challenge; physicians may avoid prescribing stronger antibiotics due to the fear that pathogens may become resistant to those as well. This then leads to further reliance on a select number of antibiotics, creating a vicious cycle.

Introduced in 1992, the Prescription Drug User Fee Act (PDUFA) allowed the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies seeking to achieve fast approval of their drugs onto the market. On June 26, 2012, the US Senate overwhelmingly passed the FDA Safety and Innovation Act (FDASIA), which authorizes PDUFA for a fifth time. Contained in PDUFA V is the Generating Antibiotic Incentives Now (GAIN) act, which is a landmark achievement in the fight against antibiotic-resistant pathogens such as MRSA.

GAIN act provides pharmaceutical companies with incentives to develop new antibiotics. Such incentives include 10 years of patent protection where the antibiotic will be exclusively sold by the maker, a shortened priority review time of 8 months compared with the standard 12 months, and a potential fast track from phase I studies to filing a New Drug Application. Such incentives may accelerate the production of novel drugs to treat infectious diseases.

GAIN is a temporary but necessary solution in the fight against superbugs. The next step is to make a greater effort to educate physicians and patients about the differences between viral infections and bacterial infections, and the appropriate use of antibiotics. Until this predicament is appropriately addressed, measures like GAIN will always be just that; a temporary solution.

Sam Hossaini