Policy, R&D

To tackle superbug scourge and revive R&D, incentivize FDA antibiotic approvals — drugmakers, health groups urge US lawmakers

As superbugs flourish, the industry players contributing to the arsenal of antimicrobials are dwindling. Drugmakers are enticed by greener pastures, compared to the long arduous path to antibiotic approval that offers little financial gain as treatments must be priced cheaply, and often lose potency over time as microbes grow resistant to them. For one of the biggest threats to global health, the lion’s share of antibiotic development is taking place in a handful of labs of small biopharma companies as their larger counterparts focus on more lucrative endeavors. Existing incentives to entice antibiotic R&D are too feeble to fix this broken system, a group of drugmakers, public health organizations and doctors said in a letter to US lawmakers on Tuesday, urging Senators to take a fresh approach to stimulate antimicrobial drug development by enacting policy measures to increase the value of a marketed antibiotic.

Beyond the incentives already in place to push drugmakers to develop antibiotics, the group urged the passage of “pull incentives,” or policy measures to increase the value of a marketed antibiotic by rewarding drugmakers only after their antibiotic is approved by the FDA.

The group represented in the letter include both big drugmakers (GSK, Merck, Pfizer) and small (Achaogen, Melinta, Paratek, Tetraphase) as well as organizations such as the Antimicrobial Innovation Alliance Antimicrobials Working Group, Infectious Diseases Society of America and The Pew Charitable Trusts.

Other lawmakers have voiced similar concerns and proposed alternative ways to reinvigorate antibiotic R&D. Last month, a UK government report outlined a plan to de-couple price from demand and shift to a more value-based approach that would compel institutions to pay fees based on their need for new antibiotics, akin to a licensing approach that FDA commissioner Scott Gottlieb suggested in recent months.

“(The) future of antibiotic development is grim…Few major pharmaceutical companies remain engaged in antibiotic discovery and development, and small biotech firms, even those that have launched or are close to launching products, struggle to sustain a viable commercial enterprise,” the group wrote, noting that of the current drugs in development, only 11 have the potential to address the most critical Gram-negative pathogens on the WHO’s priority list of antibiotic-resistant microbes.

Meanwhile, there are over 1,000 cancer drugs in development.

Each year in the United States at least 2 million people contract an antibiotic-resistant infection, and at least 23,000 people die, according to the CDC.

The mass exodus of large players, including Allergan, Sanofi and AstraZeneca is now impacting smaller drugmakers. Historically, small companies would shepherd antibiotics through the early stages of development, and then seek a partner with deep pockets to help cross the finish line — but with a paucity of Big Pharma in the field, smaller players are struggling, they wrote.

Achaogen and Melinta, collectively responsible for five recently-marketed antibiotics, have both announced the closing of their antibiotic research and clinical development programs. Several other small companies with recently approved products are in jeopardy of shuttering their operations entirely in 2019. Many of these companies received significant funding to support their R&D programs from U.S. Government funders…If they fail, it is likely to prompt the departure of what little private investment remains in the antimicrobial space, with disastrous consequences for the already inadequate pipeline.


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