Continuing the Food and Drug Law Institute’s (FDLI’s) Annual Conference on April 20, 2015, a panel then discussed Data Integrity Compliance and Enforcement (please see our earlier post here). Paula R. Katz, J.D., Director, Guidance and Policy, Office of Manufacturing Quality, Center for Drug Evaluation and Research (CDER), noted that the Center sees many data integrity issues, as reflected in many warning letters. Companies that do not have test data that comes out the right way often will find another test and only report the new data or if borderline, retest until test into compliance and only report the one that passed, Katz said, which is a problem necessitating better audit trails. Cathy Burgess, Partner, Alston & Bird LLP emphasized that it is important for companies to address data integrity issues immediately, because corporate officers can be liable, and staff training is critical for regular and unbiased audits and good reporting mechanisms. Anton-Lewis Usala, M.D. President and CEO, CTMG, Inc. said if there is no quality system requirements at the current Good Clinical Practice (cGCP) level, quality data is not assured at clinical site. Usala noted that physicians often do not have access to quality data systems unless they have worked in industry and do not really understand the need for standard operating procedures (SOPs), real-time reporting, or adaptive investigative site management. Usala provided data from a study comparing a site-specific research organization (SSRO) to a CRO, where regular data reporting helps to keep clinical data at a high quality and lower cost, as well as fewer enrolled patients with less reporting errors or Part 11 compliance issues.
The afternoon featured break-out sessions from all of the FDA Centers, leading to lively reactor panels and audience questions, followed by issue-focused breakouts. The CDER Breakout Session was moderated by Brian Malkin, Senior Counsel, McGuireWoods. Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs, CDER, presented a comprehensive look at CDER’s top initiatives. Throckmorton noted that CDER expects more public meetings to drive the next user fee meetings. He expects there will be more interaction with FDA and states to regulate compounding, while preventing duplication, for more consistent results. Phillip Katz, Partner, Hogan Lovells, asked Throckmorton what drives FDA regulation versus guidance or some other communication about policy, which Throckmorton said is a case-by-case decision, e.g., biosimilar product naming would likely be conducted by guidiance. Throckmorton said that CDER believes for quality continuous manufacturing will be “terribly important” but not an expectation. And Throckmorton entertained a number of questions on compliance, asking what would be “carrots” to get it right, for example, reduced inspectional frequency.
On the second day, Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, reflected on Hamburg’s speech six year ago, where she talked about streamlined warning letters, an empowered staff for more proactive recalls, and guidelines for using the “Park Doctrine” to hold corporate officials accountable. Sklamberg said that FDA is still looking for voluntary compliance, as well as “energetically” developing new public health measures under FSMA, such as immediate suspension and recalls, administrative detention, and mandatory recalls. With the Drug Quality and Security Act (DQSA) and the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA is also looking to expand tools for safe and effective drugs– high levels of quality beyond legal minimum–implementing warnings, seizures, recalls, import alerts, and criminal enforcement–as well as tools to inspect firms more aggressively in lieu of inspections, and may block imports if kept from inspecting overseas.
Following Sklamberg, there were panel discussions featuring the top 20 cases in food and drug law to watch, various hot topic round tables, biosimilars, a Federal Trade Commission update on health claim substantiation, and healthcare economics promotion and collaboration. FDLI’s Annual Conference was busy event with something for everyone.