Developing the right OTC label can be a long, iterative process. Companies must repeatedly test to determine whether consumers—including
those with limited reading skills—will understand it. FDA's OTC Division may also require special behavioral studies, called
Actual Use Trials (AUTs), to see if consumers will follow label instructions in the real world.
"We need to see AUTs when there are no other drugs with the indication already out there," said Ganley. "In Prilosec's case,
it was the first drug of its kind to go over the counter, so we had to be sure it would be taken correctly and by the right
The Big Event: The Advisory Committee Meeting
Often, FDA will turn to one of its advisory committees for advice on whether or not to switch a drug over the counter. For
companies, that means that, after years of conducting studies and investing millions of dollars, much of the decision about
whether consumers can use a drug safely and effectively without a prescription winds up in the hands of about a dozen people.
Therefore, for companies, making an impression comes down to the FDA Advisory Committee hearing. That is where sponsors present
their rationale and data to support the switch and address any lingering questions from committee members. And, since FDA
usually follows the committee's recommendation—as it eventually did in Prilosec's case—convincing the committee is critical,
and strategic preparation is key.
Start early A successful advisory committee meeting does not just happen by itself. The preparation process should begin as the company
is finalizing its application for FDA review.
"You cannot start the process of preparation too early," said John Dent, former director of R&D at GSK Consumer Healthcare
and leader of the team that successfully convinced an advisory committee to recommend the Rx-to-OTC switch of the weight loss
drug Xenical (orlistat). "In the ideal world, you should start preparing your presentation for the advisory committee hearing
as you prepare your NDA submission."
Other experts agree. "The case must be built brick by brick, from the first pre-IND all the way through post-marketing," said
behavioral scientist Saul Shiffman, who also presented at the orlistat hearing. "Building the Rx-to-OTC case is not just about
the science—you also have to consider the politics, public, and media, because these factors influence how science is seen."
Build an expert team To truly shine at the committee meeting, companies must build a team of expert advisors that includes scientists and academicians,
and regulatory, marketing, and FDA communication specialists. Each of these disciplines offers a unique perspective, and helps
ensure messages are credible, accurate, and resonate with committee members.
"Try to assemble a team with track records of success with advisory committees, and strike a balance between scientific and
marketing experience," said Jerry Gardner, MD, who spent 20 years at NIH and now analyzes data for pharma. "Each specialty
is important and should have a seat at the table."
A balance of internal and external presenters is key. Internal presenters tend to best know and understand the data, while
external thought leaders add credibility to the presentation. "Experienced clinicians provide an objective perspective on
safety, efficacy, and labeling," said David Peura, MD, associate chief of gastroenterology and hepatology at the University
of Virginia Medical School, whom P&G enlisted in the Prilosec switch. "Because they are on the front lines, they can answer
questions from fellow clinicians on the advisory committee."
But working with physician thought leaders and other outside experts can pose challenges. Outside presenters must learn the
data, be willing to participate at meetings and rehearsals, and work closely with FDA communications specialists to develop
their presentations and craft answers to questions the panel members may ask. The entire process usually takes months, and
patience is critical. "It is essential to communicate the likely time requirements to outside presenters up front," says Dent,
"to make sure they can give you the time you need."