Sustained regulatory compliance is a goal that should be emphasized at all pharmaceutical firms, and for that matter at any firm regulated by FDA. From a post-market perspective, FDA’s Office of Regulatory Affairs (ORA) is the organization that is most likely to interact directly with a firm. ORA comprises the group of FDA investigators, who are stationed throughout the country (and now even internationally). These investigators, individually or in teams, are tasked by ORA to perform inspections; issue a list of inspectional observations (Form FDA 483); write an Establishment Inspection Report (EIR); and classify an inspection for possible regulatory action.
With the advent of the Internet, this process has over the years become much more transparent. FDA’s website provides valuable information that firms can use to understand the regulatory process and achieve inspection readiness. However, it is also important to be mindful of trends, developments and areas of concern that inevitably arise in response to issues and events that occur in the marketplace and within industry sectors. At “Focused Trends from the FDA” presented by the ISPE Boston Area Chapter on September 21, I will review several of these key trends:
- Data Integrity This issue remains an absolute priority for CDER. FDA’s latest guidance and expectations from the March 30, 2017 presentation to the Society for Quality Assurance will be reviewed.
- FDA’s Program Alignment Initiative This program is directed at enhancing ORA’s inspection process. An example of a recent Warning Letter issued in conformance with this model will be reviewed.
- EU/FDA Mutual Recognition Agreement Not only will inspectional findings be leveraged but inspection reports, including non-public, commercially confidential (trade secret) information may be shared between inspectorates.
- Application of the Responsive Corporate Officer Doctrine Using this doctrine, violations of the Food, Drug and Cosmetic Act have resulted in individuals being criminally prosecuted. This year the Supreme Court let stay a 3-month prison sentence handed down for violations of the Food, Drug and Cosmetic Act.
Speaker Bio: Mark Lookabaugh is a 31 year veteran of FDA with broad experience in the operations of ORA, from the perspective of an analytical chemist, a participant in numerous inspections of pharmaceutical firms, a compliance officer and finally as the Director of the Compliance Branch in the New England District Office. Since 2006 he has worked in the Strategic Compliance unit of PAREXEL Consulting actively assisting pharmaceutical and medical device firms dealing with potential and actual regulatory actions, both within the U.S. and internationally.