FDA Senior Staff Members File Incomplete Applications for Outside Work
Most FDA senior staff members who applied for permission to consult, lecture or perform other activities outside of the agency between 2000 and 2003 filed incomplete applications, according to a review by the HHS Office of Inspector General released on Thursday, the Baltimore Sun reports. FDA allows its employees to teach, write and perform outside work after applying to do so and receiving approval. However, incomplete applications can "mak[e] it difficult to determine whether the work created conflicts of interest," according to the Sun.
According to the report, FDA approved 23 of 90 senior staff applications during the years studied. Half of the applications were approved after the activities had already begun. In addition, answers on applications often were short or vague and did not sufficiently describe the nature of the outside work, according to the report.
Senior officials also failed to report their outside activities on annual financial disclosure forms in nearly 50% of cases. Most of the officials had one or two outside activities and did not receive payment for them.
The report states, "The extent and frequency of these deficiencies in the forms we reviewed raise systemic concerns about how FDA collects and reviews information regarding employee's outside activities."
Acting FDA Commissioner Andrew von Eschenbach said the agency has taken steps to address the deficiencies by revising its permission form and ensuring that senior officials report outside work on financial disclosure forms. He added that the agency is writing new policies, automating its application system and developing new ethics training, the Sun reports (Rockoff, Baltimore Sun, 2/10).