Monday, July 11, 2016

A Proposal To Spur Pharma R&D Investment Into Antibiotics For 'Superbugs'

Concern continues to grow over the emergence of bacteria resistant to current antibiotics. Things are getting so alarming that political leaders such as President Barack Obama, German Chancellor Angela Merkel and outgoing UK Prime Minister David Cameron have made antibiotic resistance a top healthcare priority in their respective countries.

Despite this crisis, many major pharmaceutical companies–the very organizations best poised to help solve this challenge–remain on the sidelines. With such an obvious medical need, why are these companies shying away from committing R&D resources to this fight? The answer lies in pharma’s business model. Companies thrive by growing their product sales. But, from a financial perspective, the potential market for new antibiotics is lackluster at best. Physicians are cautious about prescribing such drugs especially if a particular one is the last line of defense against certain bacteria. By using new antibiotics sparingly, doctors try to maximize the time it takes for resistance to develop against a new drug.

However, such conservative prescribing patterns, while important and necessary, don’t help a company’s revenues. As a result, companies prefer investing ads a panel to check on a bacterium’s resistance to an antibiotic in an antimicrobial resistance and characterization lab within the Infectious Diseasin areas like heart disease, diabetes or cancer where an important new drug will be robustly utilized.

There have been a number of proposals put forth designed to solve this problem. These tend to invoke new business models, which would seek to create global structures involving intergovernmental agencies designed to coordinate and prioritize efforts. These are interesting ideas that merit exploration. However, getting all the necessary parties to the table to hammer out the rules to make this workable is going to take a lot of time and will likely add a good deal of bureaucracy.

Perhaps there is a simpler way to encourage companies to reenter antibacterial R&D–one based on a previous precedent. Back in 1997, as part of the FDA Modernization Act (FDAMA), the U.S. Congress enacted the Pediatric Exclusivity Provision (PEP). The PEP allowed an extra six months of patent life for a drug in exchange for carrying out pediatric studies requested by the FDA with the aim of encouraging drug makers to perform clinical trials in children. Before 1997, few drugs were studied in patients under the age of 16. Post-FDAMA, this situation changed, resulting in patients and physicians knowing the pros and cons of many more drugs for pediatric use. It proved to be a win-win for the companies and healthcare.

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