Statement in Response to FDA Action

PHILADELPHIA -- The Institute for Human Gene Therapy (IHGT) at the University of Pennsylvania was notified today (Jan. 21) by the FDA that the agency was suspending eight Investigational New Drug Applications (INDs) previously issued to IHGT and pursuant to which IHGT was conducting five active clinical trials in cystic fibrosis, mesothelioma, melanoma and breast cancer, muscular dystrophy and glioma. In its letter, the FDA said that it took this action in light of its recent inspection related to the OTC clinical trial. IHGT received these findings from the FDA in a Form 483 on Wednesday (Jan. 19). Today's FDA letter said that the inspection had disclosed "...serious deficiencies in the procedures in place for oversight and monitoring of the clinical trials conducted by..." IHGT. The FDA publicly released the letter and the Form 483 today.

In light of this action by the FDA, and the agency's expressed concerns with respect to IHGT's monitoring of clinical trials, University of Pennsylvania President Judith Rodin has asked Provost Robert L. Barchi to appoint a committee of scientists without affiliation to the University to review IHGT's oversight and monitoring of clinical trials and any remedial steps already undertaken by IHGT, and to recommend any additional remedial steps that may be necessary. President Rodin has asked Provost Barchi to seek the assistance of distinguished scientists with extensive experience in clinical research. The committee will report directly to President Rodin.

President Rodin has previously appointed a committee of distinguished members of the Penn faculty, chaired by Provost Barchi, to review "carefully and completely" all aspects of Penn's research using human volunteers. The unaffiliated scientists reviewing IHGT's supervision of clinical trials will operate independently of the University review of research using human volunteers.

President Rodin said that the University has cooperated fully with all aspects of the FDA's investigation and would continue to do so. She has directed IHGT to respond promptly and completely, both to the Form 483 and today's letter from the FDA.