Letter from the Chair

Dear FDLI Members,

2016 was a year of the unexpected.  Some long-shot events won’t affect the FDA regulatory universe—Brexit, Leicester City, a 5000-1 underdog winning the English Premier League title, and the Chicago Cubs ending a 108-year World Series drought. Others are profoundly consequential: The election of Donald Trump and, in a rare fit of bipartisanship, the passage of the 21st Century Cures Act by Congress.

What will these and other developments mean? We can speculate, but as Yogi Berra reportedly said, “It’s tough to make predictions, especially about the future.” We already know that the Cures legislation and the new administration will affect FDA regulation in significant ways; the combination, along with user fee reauthorizations, will have even more profound impacts. FDA’s putting on hold its long-desired goal of regulating laboratory developed tests is just a small taste of what will come.

This is where FDLI becomes invaluable. For nearly 70 years, FDLI has been a resource for the entire regulatory community: FDA and other government agencies, industry, academia, public interest groups, and other sectors. Through conferences, webinars, the Food and Drug Law Journal, Update magazine, and other resources FDLI provides insights and information to members. (If you haven’t visited fdli.org lately, I suggest you do so, as the staff has been working hard to enhance access, and will continue to do so throughout the year.) Equally important, these same resources give members the chance to express their views and perspectives. I have long felt—and I am not alone—that one of the most valuable aspects of FDLI is the opportunity to meet and informally talk with colleagues at conferences.

FDLI provides a neutral forum where members of the community can exchange ideas, both formally through speeches, webinars, and articles, and informally, at receptions and hallway conversations. In a world where civil discourse sometimes seems to have become a lost art, FDLI is an oasis. People can express widely divergent views, without ridicule or vitriol. The value of that type of exchange should not be underestimated.

What will 2017 bring? I don’t know. But I do know that FDLI will continue to enable members—and the greater FDA community—to learn about new developments and share viewpoints. In my capacity as Chair of the FDLI Board, I look forward to working with our members and FDLI as it continues to play the role it has for decades.