Advisory Committee Votes
Orlistat “Approvable”
GlaxoSmithKline recently received an “approvable” letter from the FDA for
OTC orlistat – a huge coup for GSK Consumer Healthcare. Alli (OTC
orlistat’s brand name) will be the only FDA-approved weight loss drug
available without a prescription and the first Rx drug to go OTC since
Procter & Gamble’s Prilosec in 2003.
On
the morning of January 23, 2006, Dr. Vidhu Bansal, Director of Medical
Affairs for GlaxoSmithKline Consumer Healthcare, prayed for strength
and wisdom. Boston University obesity expert Dr. Caroline Apovian
prayed she wouldn’t pass out on the podium. And GSK’s Vice President of
Marketing, Steve Burton, arrived at 5AM, surveyed the room, tested the
microphones and carefully arranged four cans of diet soda under his
chair.
The three were among the presenters for GSK Consumer Healthcare at the
FDA Advisory Committee hearing on GSK’s bid to market an
over-the-counter version of Roche’s prescription weight loss drug
orlistat.
“OTC orlistat is potentially
the biggest commercial opportunity ever for GSK Consumer Healthcare,”
said Dr. John Dent, Sr. VP of Research and Development , OTC orlistat
project leader and lead presenter at the hearing. “Naturally we were
feeling quite a bit of pressure.”
“In today’s climate of heightened
concern about drug safety and risk versus benefit, getting approval to
take an Rx drug over-the-counter is pretty difficult in general and
every project has its own unique challenges,” said Dr. Dent.
Recognizing the challenges, Dent began to prepare for the Advisory
Committee hearing seven months before the scheduled date, building a
strong team that integrated both internal and external experts in a
variety of disciplines: scientific, regulatory, marketing and
communications.
“It’s really important to have many different perspectives every step
of the way,” said Burton. “You need to reach early agreement on a
strategy and messaging but be willing to continually anticipate
arguments and be challenged by people who can tell you when you are
‘drinking your own kool-aid’ too much.”
Challenging sponsors on their messages and their answers to tough
questions is part of what 3D Communications does for pharmaceutical and
consumer healthcare clients who are appearing before the FDA or its
advisory committees. 3D helped GSK formulate communications strategy,
messages, presentations and answers to difficult Q&A for the
Advisory Committee hearing, coached presenters on effective delivery,
and - working with Healthstar Public Relations - trained a variety of
orlistat spokespeople for media outreach.
Dr. Saul Shiffman, who presented the data on how consumers would use
orlistat in the real world, said the team’s early outreach to thought
leaders and stakeholders was key to its success.
“GSK acknowledged every concern and addressed each one with data,
expert opinion and plans for education, surveillance and management,”
said Shiffman.
It paid off. The Advisory Committee voted 11-3 to recommend for
approval. Orlistat was the only first-in-class compound to win a
positive recommendation on its first try before an advisory committee
in more than a decade.
“Ultimately, given the obesity crisis and orlistat’s outstanding safety
profile, the panel concluded that the risk-benefit with orlistat was
overwhelmingly on the side of benefit,” said Dent.
So what did they do to celebrate?
Vidhu Bansal went on vacation. Saul Shiffman went to sleep. Steve
Burton went out to dinner with his family. And John Dent? He retired --
and will steer his newly purchased 1970-vintage Lotus Elan around a
racetrack.
“My retirement was long planned, but what a way to end my 25-year
career at GSK,” said Dent. “It’s a wonderful way to move on to the next
phase of my life.”
For more information on 3D Communications’ FDA Communications services, contact Cindy DiBiasi at cdibiasi@3dcommunications.us.
