FDA "consent agreement" with THA investigator

Executive Summary

Confirmed in May 4 letter from FDA Scientific Investigations Division Director Frances Kelsey, PhD, MD, to William Summers, MD. After receiving from Summers a "plan of continued compliance of clinical investigation" on April 10, Kelsey stated: "We consider your plan to represent a consent agreement with the agency, and to indicate our concurrence have signed it." Summers submitted the plan, outlining his intention to conduct investigations in accordance with FDA regs, to avoid being disqualified by the agency as an acceptable clinical investigator. The agency informed Summers of problems in the conduct and reporting of his study in early 1988. Published in the Nov. 13, 1986 New England Journal of Medicine, the study suggested dramatic improvement in patients taking tetrahydroaminoacridine (THA). . . .