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# Concerns on FDA Gastroparesis Guidance
- URL: https://www.fdaweb.com/concerns-on-fda-gastroparesis-guidance/
- Published: 2019-10-22T12:00:00.000Z
- Updated: 2026-09-15T01:58:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145310

The Gastroparesis Clinical Research Consortium says it agrees with many statements in a recent FDA guidance on gastroparesis that “provides much needed information for conducting clinical trials for pharmaceutical companies for drug approval for gastroparesis.” The consortium’s comment [letter](https://www.regulations.gov/document?D=FDA-2015-D-2479-0013&ref=fdaweb.com) raises concerns in these areas: 

- FDA is sending a conflicting message about use of a single symptom endpoint;
- it may not be realistic to do a randomized controlled trial of safety lasting for a year for ethical, practical, and economic reasons;
- regular opioid users should not be studied as they bring in patients with predominant pain and the opioids can delay gastric emptying and produce gastrointestinal symptoms; and
- there is a need for a daily assessment of gastroparesis symptoms.

Vanda Pharmaceutical [says](https://www.regulations.gov/document?D=FDA-2015-D-2479-0015&ref=fdaweb.com) the “recommendations outlined in the guidance are narrow and restrict innovations for no apparent scientific reason.” Vanda says the guidance presents a development plan that is neither optimal nor does it represent a critical path for development of new gastroparesis treatments. And it says the guidance states that there are no validated scales to measure symptoms in this indication, “dismissing the extensive scientific literature on gastroparesis evaluation scales” as unnecessary and wasteful.

Finally, the International Foundation for Gastrointestinal Disorders offers line-by-line technical [comments](https://www.regulations.gov/document?D=FDA-2015-D-2479-0014&ref=fdaweb.com).