HHS Report Criticizes FDA’s Human Subject Protection Efforts and Lack of Site Audits
The U.S. Food and Drug Administration (FDA) audited fewer than 1% of investigative sites, the inspector general of the Department of Health and Human Services (HHS), Daniel R. Levinson, found in a report released Friday.
The 41-page report said the FDA has just 200 specially-trained inspectors to audit an estimated 350,000 investigative sites. Others estimate that the number of sites is much lower.
The report found that federal health officials did not even know how many clinical trials were being conducted in the U.S. According to CenterWatch, an estimated 59,000 drug trials, phases I, II and III, were being conducted worldwide in 2006.
The Office of Inspector General (OIG) investigated after receiving a congressional request to review FDA’s oversight of clinical trials a series of news articles highlighted vulnerabilities, the OIG report said. “The series identified problems with FDA’s oversight of clinical trials, including insufficient informed consent procedures, inadequate training and certification requirements for IRBs, limited Federal regulations, and FDA’s failure to enforce existing regulations,” the OIG report added.
The report said FDA “views its protocol review before a clinical trial commences as the most important step in protecting human subjects. We recognize the important role that FDA’s protocol review plays in protecting human subjects and made several changes to our report to reflect this point. We do note, however, that this report addresses another important part of the system for protecting human subjects: oversight of the trials once they are actually underway.”
Levinson’s report said that when those overburdened inspectors found serious problems in clinical trials, their superiors in Washington downgraded their findings 68% of the time. And the report found that in the remaining cases, the FDA almost never followed up with inspections to determine whether the corrective actions that the agency specified had been done.
“The report issued today by the Department of Health and Human Services Office of Inspector General offers valuable insight into FDA’s program to protect clinical trial participants. The agency agrees with the report and is already acting on all its recommendations. Volunteers play a critical role in making treatments available that help millions of patients and FDA is committed to ensuring strong oversight to protect participants,” said Heidi Rebello, spokesperson for Office of the Commissioner at the FDA.
As its mission has grown, FDA has been widely criticized as underfunded in numerous areas beyond clinical trials, such as drug importation and food safety.
The HHS’ inspector general found the FDA disqualified investigators from conducting clinical trials 26 times from 2000 to 2005 and disqualified their data only twice even though the agency found serious problems at trial sites 348 times during that period.
The inspector general also recommended that the agency create a registry of continuing clinical trials, launch a registry of research ethics boards, build a database to track its research inspections and get more authority to regulate research assistants.
OIG identified five steps that could take to improve its system of oversight:
- Develop a comprehensive internal database of all clinical trials,
- Create a registry of IRBs,
- Create a cross-center database that allows complete tracking of FDA inspections,
- Seek legal authority to provide oversight that reflects current clinical trial practices; and
- Establish a mechanism to provide feedback to FDA district office staff on their inspection reports and findings.
Read the OIG report here.