If You Don't Succeed, Try Again
Even with all this preparation, the Advisory Committee may not decide in favor of the switch. But losing with NDAC doesn't
mean a company should stop trying. It took the Prilosec team two appearances before the committee to win a positive vote.
The first time, in 2000, the panel asked for more data. The second, in June 2002, the vote was an overwhelming 16-2 in favor
of recommending approval.
"We definitely learned from the first time around," said Bierer. "The second time, our team started preparing earlier, defined
our OTC target population more clearly, sharply focused our messages, and drilled on Q&A five times as much."
All the work paid off. FDA approved Prilosec OTC in June 2003—one year almost to the day the advisory committee voted "yes."
Penny Daniels, Carmie McCook, and Jim DiBiasi are principals of 3D Communications, an agency in Bethesda, Maryland that consults on regulatory issues. They can be reached
at
http://www.3dcommunications.us
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