Zantac

There was a time when everyone was bullish on Rx-to-OTC switches.

Schering-Plough had made the prescription-to-nonprescription crossover with its blockbuster allergy drug Claritin not too long after third party payer Wellpoint petitioned the Food and Drug Administration to forcibly switch the entire class of nonsedating antihistamines, which includes AstraZeneca's Allegra and Pfizer's Zyrtec.

Today, Schering-Plough may be fielding the first over-the-counter blockbuster drug--the company announced in March it had broken the $1 billion barrier with its Claritin franchise across all channels.

With sales of $243.8 million across food, drug and mass (minus Wal-Mart) for the 52 weeks ended March 20, according to Information Resources Inc., Procter & Gamble may have the second true OTC blockbuster soon.

And even though both Johnson & Johnson and Pfizer recently switched maximum-dose strengths of their H2-blockers PepcidAC and Zantac 150--J&J in September 2003 and Pfizer in January 2005, respectively--the climate surrounding switch has chilled of late.

Some are questioning the FDA's ability to separate science from poetics, as Barr Laboratories' switch application for the emergency contraceptive Plan B--approved for sale OTC by an FDA advisory committee in December 2003 by a vote of 23 to 4--still has yet to receive the agency's official stamp of approval. In fact, in May 2004, the company actually received a "not approvable letter in regard to the switch of Plan B.

Barr has since reapplied, but the application has remained more or less in limbo.

Is politics to blame?

"It's pretty clear in this situation," noted Randy Juhl, vice chancellor at the University of Pittsburgh. "There's no concern about the safety and efficacy of this product.... The advisory committee was near unanimous in its recommendation, the scientists inside of FDA made their recommendation to approve it, so it's pretty clear that something else is influencing the situation, and you don't need to be a genius to figure out it has other political ramifications."

Sens. Patty Murray, D-Wash., and Hillary Clinton, D-N.Y., have held up the confirmation of acting FDA commissioner Lester Crawford until a decision has been made regarding the switch of Plan B, further propagating the notion that the FDA's decision will be based on politics rather than science. There were rumors circulating around the Hill that Crawford's confirmation was to have gone through in mid-May, suggesting a decision regarding Plan B was imminent. However, nothing has happened to date.

According to published reports, Barr may pursue legal action against the agency if Plan B isn't switched. Already, the Center for Reproductive Rights tiled suit against the FDA for failing to approve Plan B as an OTC option in January, following the agency's announcement it would delay any decision on the Plan B switch application.

There is more at stake than simply approving the drug for sale over-the-counter, however. In its not approvable letter to Barr, the FDA called into question the appropriateness of this drug for the teen population, citing lack of actual use data among the underage population. Barr has since proposed to voluntarily limit sales of the medicine to women over the age of 16, requiring a prescription for those younger. That would place the onus on the pharmacist to enforce that policy, again on a perceived voluntary basis being as there is no regulatory mechanism currently in place to make a medicine available OTC to one potential patient population but not another.

Even if the FDA were to set precedent and approve Plan B based on Barr's marketing plans, there is a question on whether future private label manufacturers of Plan B would have to follow through on those guidelines.

In other switch news, the FDA is rumored to have sent Merck a not approvable letter regarding the company's January presentation to switch its statin Mevacor. During the two-day meeting before the Nonprescription Drugs and Endocrinologic and Metabolic Drugs FDA advisory committee panels, there was some debate over how to interpret Merck's actual usage data. Merck reported that the number of consumers who self-selected correctly on whether to use Mevacor fell in line with industry standards, while an FDA representative countered that only 3-out-of-209 patients who actually decided to take the statin correctly self-selected.

"You always expect the manufacturer to present themselves in the best possible light," remarked Juhl, who at one time chaired the FDA's Nonprescription Drugs Advisory Committee. The problem with Mevacor may have been in the complexity of instructions for an asymptomatic, chronic condition. "The more steps along the [decision tree] that you have to take, the more opportunity there is for an error on the part of the consumer," he said. "What needs to be done, though, is to examine the potential consequences of those missed decisions. If you look at it that way, I don t think it looks nearly as grim as the FDA reviewer made it sound."

While Bristol-Myers Squibb and Bayer, who have joined forces in potentially presenting a switch application for BMS' Pravachol statin, may be facing an uphill battle, there may yet be an OTC statin on the market, experts are saying.

The Pravachol submission with Bristol Myers and Bayer collaborating, I think will be much more successful, commented Steve Francesco, an expert on OTC medicines and publisher of Switch magazine. Francesco noted that BMS' first go at the statin switch in 2000 was much more successful than was Merck's at that time, and now BMS and Bayer have the benefit of learning from Merck's mistakes. [Merck] should not have presented that [usage] data," Francesco said. "They set back [the] switch [process for statins] because it really looks like a lot of [malarkey]."

"The question of a statin over-the-counter," Juhl posited, "although it's not dead, it's on its last lap. It's either going to make it to the finish line, or it isn't in the next year or two. ... [It] still ... can go either way."

The only other potentially imminent switch on the horizon is GlaxoSmithKline's orlistat, a weight-loss drug currently sold by Roche as prescription-only Xenical. While a history of adverse side effects, such as gas and oily stools, could pose marketing challenges to GlaxoSmithKline, the drug is generally considered safe. However, there may be some concern over how to market weight-loss medicines to a public who continues to seek a diet in a bottle, judging from the continued success of diet aid supplements--the category generated $211.2 million in sales for the 52 weeks ended March 20, according to IRI.

And allegedly not on the switch scene is Sanofi-Aventis' Allegra. Even though Barr recently won approval to sell a generic version of Allegra-D, Sanofi recently affirmed the company does not want to switch Allegra at this time.

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