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# GAO Faults FDA on Orphan Drug Records
- URL: https://www.fdaweb.com/gao-faults-fda-on-orphan-drug-records/
- Published: 2018-11-30T12:00:00.000Z
- Updated: 2026-09-15T00:47:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142936

A new Government Accountability Office (GAO) [report](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTgxMTMwLjk4NDMzMjQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE4MTEzMC45ODQzMzI0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDEwODI0JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&105&&&https://www.gao.gov/products/GAO-19-83?utm%5Fcampaign=usgao%5Femail&utm%5Fcontent=topic%5Fhealth&utm%5Fmedium=email&utm%5Fsource=govdelivery) recommends that FDA ensure that information from orphan drug designation applications is consistently recorded in Office of Orphan Products Development (OOPD) review templates and evaluated by OOPD reviewers when making orphan designation decisions. The GAO review found that the agency does not consistently record background information in standard review templates, such as a drug’s U.S. marketing history. “Officials told us this information provides important context, such as whether FDA has experience with a little known disease, critical to ensuring a complete designation application review,” the report says. Consequently, FDA cannot be sure that reviewers are conducting complete evaluations that include all critical information needed for assessing its criteria, it says. In response, the agency concurred with GAO’s recommendation.