Emergency preparedness

Why FDA Commissioner Gottlieb thinks licensing antibiotics can stimulate R&D

Borrowing a page from the software industry, FDA Commissioner Scott Gottlieb believes that licensing rather than selling certain antibiotics could help address the crisis of multidrug resistant pathogens. He is hoping to work with CMS to test the idea in Medicare.

The licensing proposal aims to change what all parties agree is a broken commercial model for antibiotics by de-linking revenue from unit volume.

Antibiotic stewardship to counter infections that are resistant to existing drugs and prevent development of resistance to new ones causes hospitals to hold new antibiotics in reserve, especially those with a new mechanism of action.

This stewardship results in little to no revenue in the traditional payment system based on units sold -- a huge disincentive to pharma and VC investment in antibiotic R&D.

“What this can do is change the paradigm so you can actually create a natural market for these kinds of drugs.”

Scott Gottlieb, FDA

Under the proposal Gottlieb outlined in a June 12 statement, hospitals would purchase an annual license for a defined number of

Read the full 1684 word article

User Sign In