FDA WARNING_LETTER - Houser, Elizabeth E. MD - January 06, 2011

This Warning Letter to Dr. Elizabeth E. Houser details objectionable conditions observed during an FDA inspection from December 6, 2010, to January 6, 2011, concerning clinical investigations of flibanserin (Protocols #511.75 and #511.84) for Boehringer Ingelheim Pharmaceuticals.

The FDA concluded that Dr. Houser did not adhere to statutory requirements and FDA regulations. Key violations include:

1. **Submission of False Information [21 CFR 312.70(a)]**: For Protocol 511.84, Clinical Global Impression (CGI) of Severity and CGI of Efficacy Index assessments for Subject 27881 (Visits 2, 4, 5, 6, and 7) were falsely attributed to a sub-investigator by the study coordinator, who did not conduct them. This compromises study integrity and data reliability.

2. **Failure to Conduct Investigation According to Plan [21 CFR 312.60]**: * **Off-site Visits and Unqualified Assessors**: For Subject 27881, Visits 2, 4, 5, 6, and 7 were conducted off-site, contrary to protocol. Additionally, CGI assessments for these visits were performed by the study coordinator, who lacked the required credentials (D