Dr. Doug Bierer felt like he was in a courtroom, waiting for the jury to render its verdict. It was June 2002, and executives
from Procter & Gamble and its partner AstraZeneca had just finished presenting their bid to FDA's Non-Prescription Drugs Advisory
Committee (NDAC) to market the popular heartburn medication, Prilosec (omeprazole), as an over-the-counter (OTC) drug.
Doug Bierer, former regulatory chief for P&G
The crowd buzzed with anticipation. Reporters shuffled papers as they prepared to record the committee's decision. A sudden
hush came over the room as the panelists began to vote.
"I vote yes."
"Yes, with some reservations."
"Yes for approval."
Bierer, then-regulatory chief for P&G's personal healthcare products, was one of the main presenters at the hearing. He had
spent years working on the Prilosec switch, and months preparing for the NDAC hearing. As the panelists' votes stacked up
in favor of the switch, Bierer knew the effort had been worth it.
The Prilosec Rx-to-OTC switch was P&G Consumer Healthcare's single most important initiative in a decade. It was the first
over-the-counter switch in the proton pump inhibitor drug class, and the first OTC product for the treatment of frequent heartburn.
And since FDA leans heavily on NDAC's recommendations, a "yes" vote with the committee—while not a guarantee—was a good indicator
of eventual FDA approval.
More Rx brands are expected to move over the counter in the next decade. Several forces are driving that trend: With 15 blockbuster
drugs set to lose patent protection by 2008, the industry sees these switches as a way to salvage shrinking profits on big-selling
prescription drugs. Consumers also expect to save money, since OTC products usually cost less than branded pharmaceuticals
(even for patients with insurance). Regulators, too, want to make medications more affordable. FDA has even said that it wants
to increase the number of drug switches by 50 percent from previous years, and will accept foreign safety and efficacy data
in support of Rx-to-OTC petitions.
But experts like Bierer say gaining approval for Rx-to-OTC switches is becoming increasingly more difficult, and that it may
be harder to secure a switch than a FDA approval for an entirely new prescription drug. After all, sponsors applying for an
OTC switch must satisfy both the Review Division, which oversees Rx drugs, and the OTC Division, which reviews all switches.
They must also show FDA that the drug is safe and effective, and that consumers can use it correctly without a doctor's supervision.
There are also new barriers to overcome. Traditionally, marketers of drugs that treat symptomatic conditions, like allergy
and pain, have had the best shot at proving OTC claims, mostly because the symptoms help consumers remember to take the pills.
But tomorrow's OTC marketplace may include newly switched drugs for chronic conditions like high cholesterol, where the symptoms
and subsequent relief are less obvious to consumers. In fact, at least two manufacturers of prescription statins are planning
to apply for OTC status in the near future.
This could make the Rx-to-OTC process even more complex and challenging. This article helps guide pharma companies through
the switch process, and prepare for the main event—the advisory committee meeting.
John Dent, former director of R&D at GSK Consumer Healthcare