FDA, NIH working to speed new antibiotics

Share this article:

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.”
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?