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

An FDA inspection of Dr. Elizabeth E. Houser, MD, in Austin, TX, was conducted from December 6, 2010, to January 6, 2011. This initial inspection focused on two clinical protocols under an Investigational New Drug (IND) application, specifically reviewing drug dosing, accountability, IRB approvals, informed consents, monitoring, data integrity, and adverse events. The inspection was carried out under the regulatory framework of 21 CFR Parts 50, 56, and 312, governing human subject protection, Institutional Review Boards, and investigational new drug applications, respectively. At the inspection's conclusion, an FDA Form 483 was issued with six observations. The primary issue involved a study coordinator from a contracted Site Management Organization (SMO) conducting protocol activities and dispensing investigational drug for a subject at an unauthorized off-site location not listed on the FDA Form 1572. Other significant violations included enrolling and dosing subjects before receiving required laboratory results and allowing subjects to participate while taking prohibited concomitant medications, thereby failing to adhere to protocol-specific inclusion/exclusion criteria. Dr. Houser acknowledged the observations, expressing serious concern for subject safety, and stated her intent to submit a written response within ten business days. The FDA also highlighted potential enforcement actions, including civil and criminal penalties or debarment, if these issues remained uncorrected in future trials.