Clinical Data Integrity: FDA and DOJ Enforcement Priorities
Enforcement action … criminal prosecution … . If your clinical data integrity can’t withstand the increased analysis, this could be your fate.
Thankfully, there’s Clinical Data Integrity: FDA and DOJ Enforcement Priorities.
This management report features insights and advice from three prominent regulatory and legal experts, two of whom are FDA veterans and all well-versed in both data integrity and the FDA’s and Department of Justice’s (DOJ) priorities in enforcing it.
When the FDA resumed on-site domestic inspections after a COVID hiatus, sponsors saw a clear ratcheting up of concern over the integrity, validity and reliability of clinical data.
And the DOJ’s Consumer Protection Branch recently named fraud in the development of clinical data as one of its four key enforcement priorities. Not to mention the multiple news stories about prosecutions of those falsifying clinical trial data.
How will this focus on data integrity impact the development, approval and marketing of your new products? What changes must you make to ensure your clinical data passes muster with both agencies? And what might happen if they don’t?
Clinical Data Integrity will answer all of these questions and then some, guiding you to understand the new expectations and explaining how to prepare for the increased scrutiny and enforcement. All so you can turn your attention to getting your drugs and devices to those who need them.
Management report takeaways:
- How COVID-19 disruption opened the door for unintended and deliberate breaches of the development of clinical data
- Recent trends in FDA warning letters that signal a shift from the agency’s focus during the pandemic to the emerging “new normal” of scrutiny and inspections related to the development of clinical data and its integrity
- Key fact patterns that may trigger a DOJ decision, in collaboration with the FDA, to initiate criminal prosecution of an individual or firm related to fraud or falsification of clinical data used to support an application, as well as debarment by the FDA
- Best practices for spotting and mitigating high-risk issues related to the integrity of the development of clinical data and its uses before and after product approval
FDA and DOJ scrutiny is intensifying. Ensure your clinical data integrity can withstand the most rigorous examination with Clinical Data Integrity: FDA and DOJ Enforcement Priorities.
About the Contributors
About the Contributors
Beverly Lorell, MD is the senior medical and policy advisor in King & Spalding’s FDA and Life Sciences practice. Prior to joining King & Spalding, she was a professor of medicine at Harvard University, served on an FDA advisory committee and NIH panels, and was the chief medical officer of a global medical device company. Dr. Lorell specializes in the areas of clinical trial design and conduct of studies of drugs and medical devices as well as the assessment of issues involving a risk to health or data integrity that are under the spotlight of the FDA and other federal scrutiny. She regularly assists clients in the design and conduct of urgent internal investigations of high-risk issues in global clinical trials related to potential violations of the protection of human subjects as well as clinical trial data falsification and fraud.
Peter Leininger is a partner in King & Spalding’s FDA and Life Sciences practice. He represents medical device, pharmaceutical and biotech companies in FDA regulatory and enforcement matters, with an emphasis on civil, criminal and internal investigations. Prior to joining King & Spalding, he served as an associate chief counsel for enforcement in the FDA’s Office of Chief Counsel. Mr. Leininger’s enforcement practice at the FDA covered the range of FDA-regulated products, often focusing on product quality issues and clinical trial fraud.
Mark Brown is a partner at King & Spalding and the chair of the firm’s FDA and Life Sciences practice. Prior to joining King & Spalding, he was an attorney in the Bureau of Consumer Protection at the Federal Trade Commission, where he concentrated on consumer fraud. He was subsequently an associate chief counsel for enforcement in the FDA’s Office of the General Counsel and a top litigator in FDA enforcement actions.
Who Will Benefit
- Legal leadership and staff
- Regulatory officers and staff
- Compliance officers and staff
- Research and development staff
- Principal investigators
- Data managers
- Clinical research coordinators
- Clinical research monitors
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Beverly Lorell, MD, Peter Leininger and Mark Brown
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