The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail certain “objectionable conditions” observed during prior FDA inspections and focus on the activities of the providers’ institutional review boards (IRBs), which are responsible for reviewing clinical trial procedures.
The FDA sent two of its recently published letters to an Indiana-based pain management company, which operates clinics in its home state and in California. The letters set out a number of deficiencies associated with the company’s IRB and a clinical trial of an unspecified medical device. Among other things, the FDA said in the first letter that the company failed to take certain measures to ensure that voting members of the IRB did not have a conflicting interest in the trial being reviewed; failed to implement adequate written procedures governing the functions and operations of its IRB as it related to research review; and failed to adequately document certain of the IRB’s activities. The FDA also identified deficiencies in the company’s informed consent document for the trial, including its failure to state the purpose of the trial and the expected duration of a patient’s participation.
According to the FDA’s second letter, the pain management company failed to submit and obtain FDA approval of an Investigational Device Exemption, or IDE, before treating nine patients in connection with the study. This failure, the FDA said, may have “place[d] study subjects at increased risk of harm and serious illness.” The FDA also noted, among other things, that the company failed to obtain informed consent from participating patients in accordance with federal regulations, noting that the company’s previous action steps to address informed consent issues were inadequate. According to both letters, the company was required to submit written corrective action plans to address the deficiencies identified by the FDA.
The third letter involved an Idaho hospital’s participation in clinical trials of prescription drugs, including atypical antipsychotics. According to the letter, the hospital failed to comply with federally mandated protections for children participating in the studies. According to the letter, the hospital IRB failed to notify the study’s investigators of conditions of approval of studies involving the use of antipsychotics in adolescent patients. The FDA also cited the hospital IRB for, among other things, failing to maintain appropriate written records of IRB activities and failing to conduct certain continuing reviews of its research. Like the letters to the pain management company, the hospital was required to submit a written corrective action plan.