Making the Switch

More companies are using Rx-to-OTC switches to extend a brand's lifecycle. Prilosec did it. Here, experts dish on how you can do it too.
Apr 01, 2007

Doug Bierer, former regulatory chief for P&G
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.

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.

News Flash
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.

John Dent, former director of R&D at GSK Consumer Healthcare
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.

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