HIGHLIGHTS! ENFORCEMENT, LITIGATION AND COMPLIANCE

The Food and Drug Law Institute (FDLI) is on day two of the Enforcement, Litigation and Compliance conference. The annual meeting always provides excellent insight into the areas of focus, agendas, and opinions of FDA and other agencies, such as DOJ and FTC.

Some of the key take aways are provided here for those of you who could not attend:

• The DOJ Voluntary Self-Disclosure program applicable to corporate criminal prosecution was reviewed. The link to FDA was the DOJs approach to not criminally prosecute those who have come forward in a timely manner to self-report data integrity violations. The acceptable provisions to avoid criminal prosecution are clearly outlined on the DOJ website. https://www.justice.gov/corporate-crime/voluntary-self-disclosure-and-monitor-selection-policies. As data integrity continues to be a hot topic in drug manufacturing and an aggressive pursuit in the case of clinical trial data, it is good to know that "honest" mistakes can be reported and resolved without jail time.

• The DOJ discussion of the Voluntary Self-Disclosure program did not appear to be coincidental give the overarching theme which developed across the two days, that of Clinical Data Integrity (DI). In multiple presentations, enforcement actions against clinical research organizations (CROs), and clinical investigators were highlighted. Furthermore, in the update from the Biomonitoring Program (BIMO), FDA’s education of the investigations force was aligned with their focus on DI. FDA is partnering with the Society of Quality Assurance (SQA), Veeva, Pharmalex and Instem, providers of clinical data management systems, to train Investigators in the use of these systems. When asked if this meant Investigators would be taking “the wheel” during inspections or still looking over the shoulder, Mr. Pittman, Division Director, ORA replied, “taking the wheel”.

• Each of the Centers presented updates to their organizations and highlighted specific areas of focus. The Center for Devices and Radiological Health (CDRH) identified the Case for Quality Voluntary Improvement Program (CfQVIP) as transitioning into a permanent program based on the learnings from the MDIC pilot.

Perhaps more interesting than CfQVIP, CDRH presented areas of focus and the reasons behind them.

• Unique Device Identifier (UDI) – Although the time for full implementation of UDI has long since passed, several manufacturers are still not complying with the UDI requirements. A survey of manufacturers was recently conducted in hopes that prompting manufacturers to respond to questions on UDI will remind them to comply and realize FDA is watching. Two (2) recent Warning Letters highlight UDI non-compliance.

• Post-Approval Studies – The audience was reminded that with many device approvals come requirements for post-approval studies. CDRH has identified that several manufacturers required to conduct these studies either have not performed the required studies or have not reported on them. There will be a focus on ensuring that these studies are conducted as required to maintain the approval.

• Data Integrity (DI) – This was an interesting addition to the CDRH watch list. The probing question was why the guidance has always been so focused on DI in pharma manufacturing and if this focus by CDRH would lead to an expansion and/or revision of the current guidance. No definitive answer was provided but certainly CDRH is looking.

• Pending Rule on 820/13485 Harmonization – When asked if the rule will be signed this year…the answer was, it’s on the docket.

• Reorganization at FDA seems to be routine; however, the recent announcement of intent to move the compliance functions of ORA out of ORA and exclusively into the Centers was a point of discussion. Specifically, the audience was reminded that this is still a “proposal” and that no final decisions have been made. This poses unique challenges for CDRH, who has not had a robust compliance division, unlike CDER, and who has worked with ORA through direct reference authority. If history is a predictor of the future, remember ORA’s Program Alignment (PAG) took over three years to implement once the decision was made to move forward. Stay tuned.

• One breakout session may be of particular interest. The discussion on Consent Decree Negotiation and Compliance. Former FDA counsel Perham Gorji walked the audience through the warning signs, which may seem obvious but are often ignored:

o Warning Letter(s)

o Regulatory Meeting, post Warning Letter

o Multiple inspection in a short period of time

o Multi-site inspections closely timed

o Violative History

Mr. Gorji also addressed some of the common provisions of a negotiated Consent Decree (CD) including, manufacturing stop, third party consultant oversight and/or certification, payment to the FDA for inspections, fines, and naming of individuals as well as the company.

Ms. Anne Miller, Legal Counsel for Medtronic, provided a relevant example of how the Medtronic CD was negotiated with FDA in 2015 and the course of actions that led to the sunsetting of the CD in August 2023. Her keys to success were, look beyond the immediate examples and examine systemic improvements, change culture, ensure cross-functional leadership and participation and use more that one SME and consultancy to evaluate different parts of the CD requirements such as supporting the corrective action plan vs. auditing progress.

This FDLI meeting is an educational conference which is not highly attended by members of industry. I would like to encourage industry members responsible for your regulatory compliance to consider attending in the future. Hearing directly from the law enforcement experts themselves can provide critical information for risk based decision making as well as afford an invaluable opportunity to speak directly to those who develop and pursue the cases across the Agencies.

I’d like to give a special thanks to the Compliance Architects (https://compliancearchitects.com) team with whom I have been partnering for their invitation and sponsorship to attend this important event.