GAO: Drugmakers Say Unclear FDA Guidance Hinders Antibiotics Development

The GAO said a lack of clarity on the role of FDA draft guidances on antibiotic drug development creates uncertainty for drug sponsors.

Unfinalized guidance on the Qualified Infectious Disease Product designation lowers the chances that companies will apply for the designation, because they do not fully understand its requirements and benefits, the GAO cautioned. Incentives available under the QIDP designation include eligibility for fast track designation.

FDA has released 14 updated or new guidance documents on antibiotic development, as required by the Generating Antibiotic Incentives Now Act of 2012 — which created the QIDP designation and required the agency to review and revise guidance documents related to antibiotics. Half of these guidances are still in draft form.