FDA recently issued a warning letter to clinical investigator Betty Tuller, PhD, after she purportedly violated several requirements under 21 CFR Part 312 while working at Florida Atlantic University’s Center for Complex Systems and Brain Sciences.
According to the letter, a 2011 FDA Bioresearch Monitoring Program inspection found that Tuller conducted 5 clinical studies of a marketed drug that required compliance with FDA’s Investigational New Drug (IND) regulations—despite the product’s currently-approved status. Among the violations outlined in the inspection report and warning letter, Tuller often failed to obtain informed consent from patients, failed to maintain adequate records, and failed to properly report to an IRB.
The warning letter clearly indicates to Tuller that “by not providing the subjects under your care with the information they were entitled to receive to assist them in making an informed decision about whether to participate in the studies, you compromised the rights, safety, and welfare of those subjects… [and] the IRB was unable to make an informed determination regarding the continued safety of the subjects enrolled in your investigations.”
The lesson here is that clinical studies of approved drugs involving new administration routes or dosage levels that increase the drug’s risks significantly must adhere to FDA’s IND regulations, requirements, and submission processes. That is, oftentimes, clinical research studies involving already approved drugs that are on the market not only need proper IRB oversight, but may also need to be conducted under an IND application.