“Drug companies, third party payers and
regulators will continue to push to switch products to over-the-counter
status, especially with 15 blockbuster drugs (annual sales more
than $1 billion) due to lose patent protection through 2008.”
-Tufts Center for the Study of
Drug Development, Outlook 2004
Despite increasing pressure from all stakeholders
to make prescription drugs more accessible to consumers, the FDA
approval process for an Rx-to-OTC switch is as rigorous as ever.
Most proposed switches still have to leap that critical final hurdle:
the advisory committee hearing.
In the second part of a two-part series, (click
here for Part I) a regulatory expert from the
Consumer Healthcare Products Association and a physician-scientist
with 20 years experience at NIH offer frank advice to pharmaceutical
companies. Learn how to prepare for the advisory committee
hearing and increase your odds of receiving a positive recommendation.
..............................................................................................................................
After years of studies, scores of late-night
company meetings and millions of dollars in investments, your
drug is finally ready
to go before an FDA advisory committee, where about a dozen people
will judge whether it can be used by consumers
without a prescription.
The advisory committee is the last
stop before FDA approval or rejection. And since the FDA usually
follows
the committee’s
recommendation, convincing the committee that your drug is safe
and effective is critical to its future. Strategic preparation
is key.
Start early and think broadly
Build a team of experts to help develop strategy
for the advisory committee about ten months prior to the meeting,
just as you’re
finalizing your New Drug Application (NDA) with the FDA.
Your team should consist of scientists and academicians in the
specialty or indication at issue, as well as regulatory, marketing
and FDA communications experts to help focus your messages.
“Try to assemble a team with track records of
success with advisory committees, and strike a balance
between scientific and marketing
experience,” said Dr. Jerry Gardner, a physician-scientist
who spent 20 years at NIH and now analyzes data for pharmaceutical
companies. “Each specialty is important and should have a
seat at the table.”
The scientists you choose to present before the advisory
committee are critical to winning approval. When selecting presenters
from outside the company, make sure they:
- agree with your analysis of the data;
- are good team players;
- actively participate in meetings;
- can give the time commitment
you need.
“Companies commonly run into problems when
outside presenters are surprised by the time involved,” said
Dr. Doug Bierer, Vice President, Regulatory and Scientific Affairs
at the Consumer Healthcare Products Association (CHPA), who was
the team leader for Procter & Gamble on the Prilosec Rx-to-OTC
switch. “It’s best to tell them upfront that preparing
for the advisory committee may take over their lives, especially
in the last couple of months before the hearing.”
But Dr. Bierer emphasized the value of having
an outside voice on your presentation team, for credibility.
P&G enlisted
the help of Dr. David Peura, Associate Chief of Gastroenterology
and Hepatology at the University of Virginia Medical School,
to provide his clinical opinion on the Prilosec switch.
“An experienced clinician provides an objective perspective
on safety, efficacy and labeling,” said Dr. Peura. “Because
they are on the front lines, they can answer questions from fellow
clinicians who are on the advisory committee.”
Know your audience and their issues
FDA advisory committees are a potpourri of specialty physicians,
scientists, statisticians, epidemiologists, toxicologists,
industry and consumer representatives. One of the biggest challenges
is
addressing each of their interests, concerns, and yes, their
biases.
With Rx-to-OTC switches, a sponsor has to win over two advisory
committees working together. One is expert in the drug’s
medical specialty; the other, the Nonprescription Drug Advisory
Committee, or NDAC, is expert in over-the-counter medications.
“One of the biggest mistakes sponsors make
is assuming advisory committee members know more than they do,” said
Dr. Bierer. “They are experts in their fields, but not
necessarily in your drug or your data.”
The experts agree: your presenters must go into the meeting with
a clear set of messages and a convincing story, and be very judicious
in selecting the data they present.
“Since the advisory committee members often
only have time to read the information the night before the meeting,
and you only have one hour to present it, you must be laser-focused
in
your
presentation,” said
Dr. Bierer. “Giving the advisory committee data without
context is a sure path to failure.”
“Great data alone is not enough,” agreed
Dr. Gardner. “You
must guide the panel through the data in a clear, logical and
persuasive way.”
In addition, your presentation must directly address the issues
that the FDA considers most critical.
“The FDA provides the advisory committee with the questions
it wants the panel to answer,” said Dr. Bierer. “Usually
the sponsor may not see the final questions until the night before
the meeting. You have to be ready to scramble at the last minute,
even to the point of changing your presentation, if necessary.”
“Remember, at the end of the day this is an advocacy presentation,
not a typical scientific one,” said Dr. Gardner. You need
to make sure presenters are compelling and convincing, while staying
true to the science.”
“
Scientists underestimate the importance of a strong delivery,” said
Dr. Bierer. “You need to show the advisory committee that
you are confident in your data and passionate about your position
on the issues. If they see that you truly believe in what you
are saying, it will help to convince them too.”
In addition, the experts have the following recommendations
for sponsors.
- Hold at least one Mock Advisory
Committee that includes your team of presenters. Throw
them tough questions for
a “reality
check.”
- Practice, practice, practice. Deliver the presentations,
both individually and together as a group.
- Visualize the big day. Show presenters a
diagram of the room, where they’ll be standing, where
their audience is positioned, etc.
- Prepare a Q&A book and drill on questions
and answers for weeks before the hearing.
“You can win or lose on Q&A,” said Dr. Gardner. “I’ve
seen companies go down in flames because they responded to the
questions with confusing data dumps. You’ve got one shot
to answer the question clearly and get your point across.
For more information on FDA advisory committees go to: http://www.fda.gov/oc/advisory/default.htm
Dr. Jerry Gardner can be contacted at:
gardnerj@scifororg.com
Dr. Doug Bierer can be contacted at:
dbierer@chpa-info.org
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