Academic Programs
Reprinted with permission of the Food and Drug Law Institute from Update magazine, June-July 2018.
Careers in Food and Drug Law
by Dale Cooke
On Wednesday, March 28, I moderated a Food and Drug Law
Institute Careers in Food and Drug Law panel discussion at
the Drexel University Thomas Kline Institute of Trial Advoca-
cy. Although I have been involved with FDLI for more than a
decade, it was only after I enrolled in law school that I learned
about FDLI’s extensive program dedicated to new food and
drug lawyers (NFDL), including law students.
This event was the first step in bringing that program to
students outside the Washington, DC metro area. In DC, the
program has been vibrant for several years. Nearly 40 students
from Philadelphia area law schools and a few local FDLI
members registered for the program.
The evening kicked off with an overview of FDLI from Amy
Rick, the president and CEO of FDLI. Laura Brown, FDLI’s
educational programs director, then provided an overview of
FDLI’s academic programming and the benefits available to
students including:
• Student Writing Competition
• Volunteer Opportunities to Attend Conferences for Free
• Training and Networking Events
Following these presentations, a panel discussion featuring
attorneys working in the food and drug area shared career
advice with the attendees. Rick shared her impression based on
being an attorney in Washington for more than 30 years that in
general, food and drug attorneys are happier than other prac-
tice areas in part because the work by its very nature involves
issues that affect everyone’s lives. “Everybody eats,” she said.
Friends and relatives can understand the role of food and drug
Dale Cooke is the president of
PhillyCooke Consulting, which helps
prescription product marketers adopt
21st century communication tools
while complying with FDA regulations
written in the 1960s.
40 Update June/July 2018
attorneys, whereas other attorneys frequently find it difficult to
explain their work and its importance.
Paul Savidge, the US General Counsel at Spark Therapeutics,
spoke about what it is like to work in a start-up environment on
cutting-edge scientific developments, particularly working in
the area of orphan diseases.
Marlene Shea, Senior Counsel, Regulatory Law for Johnson
& Johnson, spoke about her decision to move from a law firm to
working in-house, and the differing quality of life.
Commander Gayle Lawson, the pre-approval manager for
pharmaceuticals at the Philadelphia District Office of the Food
and Drug Administration, discussed the relationship between
government service and the public health, what it is like to
actually work with companies to rectify issues identified during
a site inspection, and the excitement and challenges associated
with being part of the Public Health Service.
Yvonne McKenzie, formerly a partner in a law firm and now
at Merck & Co., Inc., talked about the need for food and drug
attorneys to always be interested in learning because of the ev-
er-changing nature of the law in this area and ongoing scientific
developments. In response to a student question about some of
the hot areas where change is expected, McKenzie talked about
the Food Safety Modernization Act (FSMA). Although signed
into law seven years ago, FDA continues to roll out new aspects
of FSMA. Such ongoing changes (which are merely a fact of life
for food and drug attorneys) mean that clients need to pick up
the phone to talk to their attorneys to ensure legal compliance.
During the reception following the panel, students and
panelists exchanged contact information and continued the
discussion. Rick mentioned her desire to build on the success of
the evening’s program with future events in other cities, thereby
continuing the outreach to the next generation of food and
drug lawyers. FDLI
www.fdli.org