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# FDA Should Clarify Antibiotic Guidances: GAO
- URL: https://www.fdaweb.com/fda-should-clarify-antibiotic-guidances-gao/
- Published: 2017-03-02T12:00:00.000Z
- Updated: 2026-09-14T22:09:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138115

The Government Accountability Office (GAO) says that FDA should clarify the role of its draft guidances issued under the Generating Antibiotic Incentives Now (GAIN) provisions of the 2012 FDA Safety and Innovation Act. In its [report](http://www.gao.gov/products/GAO-17-189?ref=fdaweb.com) on implementation of GAIN, GAO also says the agency should develop guidance on the qualified infectious disease product (QIDP) designation.

The report says it is too early to tell if GAIN has stimulated development of new drugs. To look at agency implementation of the provisions, it examined steps FDA has taken to encourage antibiotic development since GAIN and also asked drug sponsors for their perspective on the agency efforts.

It notes that as of 8/2016, FDA had coordinated release of 14 updated or new guidance documents on antibiotic development. However, half the guidances remain in draft form, GAO says.

Ten drug sponsors interviewed for the report said GAIN has facilitated FDA’s review of their drug applications, and eight said there was increased communication with FDA because of GAIN implementation. However, GAO says, several sponsors were uncertain whether they could rely on FDA’s draft guidance or were concerned about the lack of guidance describing the QIDP designation and its requirements.

“The lack of clarity on the role of draft guidance for and the lack of written guidance on the QIDP designation create uncertainty for drug sponsors about how much reliance they should place on these draft documents and could diminish the likelihood that drug sponsors apply for the designation because they do not fully understand its requirements and benefits,” GAO says.

The watchdog agency recommends that FDA clarify the role of draft guidance for and develop written guidance on the QIDP designation to help drug sponsors better understand the designation and its associated incentives. The agency said it agreed with the need for a QIDP guidance and would consider the need for clarifications on the draft guidances.