Working with the private-public Biomarkers Consortium at the Foundation for the National Institutes of Health, FDA is looking at options to ease the development path for antibiotics.
Interviewed on BiocenturyTV in September, FDA drugs center director Janet Woodcock said the agency recognizes “the tension between getting the data and this huge need for new antibiotics.”
She said the collaboration “started with skin and skin structures and we've got the entire community together.”
But drug development is getting harder, Woodcock noted. “Many things have changed,” she said. “The reimbursement environment has changed, the cost of doing clinical trials has gone up remarkably.”
Asked what role FDA should play in comparative effectiveness research, Woodcock noted that comparative data will be required for certain therapies being developed for cancer or other life-threatening diseases.
Giving a Wall Street perspective, Warburg Pincus managing director for healthcare Jonathan Leff said that FDA has “a big enough challenge to balance the risk vs the benefit of new therapies... If you add a cost dimension to that or even a dimension of comparing it to other therapies, you would complicate that equation.”