FDA’s New Enforcement Strategy



9:30 a.m. – 10:00 a.m.


10:00 a.m. – 10:45 a.m.

View from FDA: What Stakeholders Need to Know

Robin Newman, Director, Office of Compliance, CDRH, FDA (invited)

10:45 a.m. – 11:00 a.m.


11:00 a.m. – 12:15 p.m.

Hot Takes on FDA’s Enforcement Strategies: A Closer Look at ORA, CDER & CDRH

For more than five decades, FDA’s Office of Regulatory Affairs (ORA) has been enforcing regulatory compliance by focusing on routine or for-cause inspections of companies. The ORA’s assumption: During an inspection FDA gets the “best case” scenario for a company and its compliance with FDA’s regulations. But some centers have noticed systemic problems with certain companies that tend to be repeated without correction, calling ORA’s approach “whack a mole.” As a result, those centers have begun adopting more targeted approaches to inspections, providing incentives to companies with cleaner records to receive less frequent inspections.

In this panel, ORA’s historic approach will be compared to the latest developments in CDER and CDRH. You’ll find out exactly how the Centers are changing the focus of inspections in 2017.

Paul Gadiock, Partner, Arent Fox
Philip Dejardins, Vice President, Global Regulatory Policy & Intelligence, Johnson & Johnson
Amanda Klinger, Partner, King & Spalding
Julie Larsen, Principal, BioTeknica

Moderator: Jamie Ravitz, Partner, Arent Fox

12:15 p.m. – 1:15 p.m.


1:15 p.m. – 2:15 p.m.

Dealing with Dashboards, Inspections and Recalls

ORA and various Centers are implementing dashboards and other new tools for handling inspections by making results more transparent and available for public viewing. For example, CDER has been working on developing an internal dashboard to figure out hot-button inspection issues for specific products. Meanwhile, CDRH is recognizing that, by identifying specific problem areas for device manufacturers, the industry can better direct its resources to fix systemic issues leading up to specific inspection issues or observations. And, at times, recalls are used as a mechanism to not only protect the public safety but also to make an example out of certain companies or compliance issue to put industry on notice.

You’ll learn just how effective these new enforcement strategies been to incentivize companies, like yours, to not only fix the problems observed by inspectors but deal with underlying problems.

Brian Malkin, Counsel, Arent Fox
Elaine Messa, President of the Medical Device Practice, NSF Health Sciences
Ricki Chase, Director, Compliance Practice, Lachman Consultants

Moderator: Emily Leongini, Associate, Arent Fox

2:15 p.m. – 2:30 p.m.


2:30 p.m. – 3:45 p.m.

Self-Regulation, Whistleblowing, Data and Quality

FDA Center are now enforcing regulations by relying on industry reporting on industry, internal checks and balances, as well as fear that without making certain quality changes, FDA will reject its data. This panel will explore whether these new initiatives.

You learn the real skinny about whether CDRH’s webpage describing how to report regulatory misconduct is having a significant impact on underlying data and quality presented to FDA and what still needs to be done to incentivize companies to self-police rather than to rely primarily on FDA as the “regulatory cop”.

Douglas Stearns, Director, Office of Global Regulatory Operations, ORA, FDA (Invited)
Teresa Gorecki, Practice Lead, Compliance Architects
Michael Gaba, Partner, Holland & Knight

Moderator: Paul Gadiock, Partner, Arent Fox

3:45 p.m. – 4:00 p.m.


4:00 p.m. – 4:45 p.m.

Open Discussion

Paul Gadiock, Partner, Arent Fox
Philip Dejardins, Vice President, Global Regulatory Policy & Intelligence, Johnson & Johnson
Teresa Gorecki, Practice Lead, Compliance Architects

Moderator: Brian Malkin, Counsel, Arent Fox

4:45 p.m.




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