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# FDA Sued Over Human Subject Protections
- URL: https://www.fdaweb.com/fda-sued-over-human-subject-protections/
- Published: 2017-11-30T12:00:00.000Z
- Updated: 2026-09-14T23:04:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140234

The Center for Responsible Science (CRS) is [suing](http://www.crs501.org/images/documents/lawsuits/filed-complaint-crs-vs-gottlieb-2017-10.pdf?ref=fdaweb.com) FDA in DC federal court to force the agency to grant a CRS 6/2014 citizen [petition](http://fdaweb.com/login.php?sa=v&aid=D5129146&searchWords=CRS&cate=S&stid=%241%24e4%2F.P4..%24e3IoX1xnEB.WsfWaEzo7S0&ref=fdaweb.com) on improved protections for human subjects in clinical trials. The petition asked that “FDA ensure every prospective trial participant receives the information necessary to evaluate the real risks posed by the drug trials in which they may participate so they can make an informed decision on whether or not to take part.”

According to a CRS [statement](http://www.crs501.org/news/press-releases/53-after-150-plus-treatment-related-deaths-in-clinical-trials-since-2014-lawsuit-is-filed-against-fda-to-increase-protection-of-human-subjects?ref=fdaweb.com), participants need to understand that the drugs they are being given have been tested largely in animal models, which are acknowledged by FDA to sometimes be unreliable predictors of human response, especially for new biologics coming to market. “Indeed,” the advocacy group says, “preclinical evaluation of human risk in animal experiments for biologics can be difficult, and sometimes impossible due to species-specific reactions, which can expose human subjects to unexpected, potentially catastrophic effects.”

FDA issued an interim response to the petition in 2014, saying it involved “complex issues requiring extensive review and analysis by agency officials,” CRS says. “However, even with the more than 150 clinical trial participant treatment-related deaths since CRS filed the petition, FDA recently provided just a brief response denying it. FDA’s response demonstrates that the agency has undertaken little, if any, review or analysis and has failed to address the serious concerns presented in the petition.”

The group says its request does not inhibit clinical research and the advancement of new medicines. It says it acknowledges that human subjects, whether healthy volunteers or patients, are currently the most powerful contributors in the identification of clinical suitability of new medicines. “The recent documented failure of traditional preclinical testing to weed out deadly toxicities leaves the human recipient as the real arbiter on the safety of new medicines,” says CRS president **Neil Wilcox**. “Those exposed to new therapies with an unknown safety profile are the true guinea pigs.”

The suit and statement contain a chart showing what CRS describes as a “dramatic rise” in treatment-related deaths in clinical trials from 1+ in 2012-2013, to 10+ in 2014-2015, to 143+ in 2016-2017.