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# FDA Use of ‘Subjective Evidence’ Questioned
- URL: https://www.fdaweb.com/fda-use-of-subjective-evidence-questioned/
- Published: 2020-07-15T12:00:00.000Z
- Updated: 2026-09-14T16:21:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147199

Four authors from law and medical schools are questioning the FDA reliance on objective evidence in approving medical products, arguing that it is difficult to obtain such evidence in treatments for brain injuries. The *Stanford Technology Law Review* [article](https://papers.ssrn.com/sol3/papers.cfm?abstract%5Fid=3253927&ref=fdaweb.com) says the current agency regulatory approval process for new drugs and medical devices reduces the likelihood that treatments for consciousness disorders will be developed.

The authors say that by demanding objective evidence to support the approval of new treatments, FDA is disadvantaging treatments for disorders of consciousness because the evidence supporting these treatments is largely subjective.

The article says that objective evidence typically includes quantitative measurements, while subjective evidence is often gathered through clinician observations or patient reports. The authors say FDA has not been transparent as to how it weighs subjective and objective evidence and they claim agency practices show a preference for objective measures.

They say that FDA guidances on the drug approval process indicate a preference for objective evidence of a drug’s effectiveness rather than subjective reports and observations. And they say some studies have indicated that the agency prefers objective evidence of a drug’s effectiveness.

The article says the FDA preference is primarily problematic because researchers have not found reliable objective indicators that can be used for determining the effectiveness of treatments for disorders of consciousness. And even if such objective indicators existed, the authors write, researchers would have to use invasive procedures to collect necessary data because the indicators would be within the brain.

Saying that they understand the agency’s concerns about the reliability of subjective evidence, the authors suggest FDA could help resolve the tension between objective and subjective evidence by when possible requiring clinicians to submit multiple forms of subjective evidence in addition to required objective evidence. They say the combination of subjective and objective evidence is particularly useful for disorders of consciousness treatments.