PE: All over the industry, companies are diving into OTC. What doesn't the industry know about managing OTC products? How is
it different than Rx pharma?
BS: OTCs are different because the way you market them and field brands is a lot different than in the Rx world. You always have
to think about innovations. An innovation in the Rx world may be a new dosage or a new indication for treating a new ailment.
In the OTC world, the innovation could be going from a pill to a liqui-gel; it could be going to an easier dosage spoon or
a swab; it could be a packaging innovation; it could be a marketing innovation. The world in some sense moves a little faster
in OTCs. In general, advertising tends to be addressed more by the FCC than the FDA. You still have boundaries, but you can
move a lot faster and execute a lot quicker in the OTC world than you can in the Rx world.
That said, both worlds can learn a lot from each other, and there's a lot of synergy between the two. There's actually an
opportunity for cross-learning because there are a lot of good things in both units that can be shared and leveraged.
PE: A couple of years ago, there was a lot of interest in Rx to OTC switches, and then Vioxx happened and everyone stopped talking
about it. Where do people stand on that today?
BS: I think the FDA still remains, post Vioxx, a bit cautious on the safety side, even on the OTC switch. But we feel more encouraged.
The switch of Xenical, which became Alli, was a good sign for the industry. FDA seems to be more open to the idea of switching
drugs for chronic therapies, whereas in the past the agency was focused more on acute episodic conditions like headache. That's
all ultimately positive, particularly when you look at some of the chronic medications that are coming close to patent expiration.
Lipitor, for example, which is the world's largest selling prescription drug—that could be a very interesting switch. That
would require a long dialogue with FDA. Of course, J&J/Merck and GSK both tried to switch Mevacor and were not successful.
When Andrew von Eschenbach was commissioner, he did speak about [creating] a third class of drugs: a behind-the-counter class.
But in a sense Schering sells one of the largest behind-the-counter OTC products in Claritin-D, which is Claritin with pseudoephedrine.
PE: Why is that "behind-the-counter"?
BS: It went behind-the-counter primarily because there was concern about people using pseudoephedrine as an ingredient for manufacturing
meth. And so many states and the federal government passed legislation to put pseudoephedrine behind the counter. It's been
a very effective program from our point of view. We feel very good about that program and Claritin-D users know where to find
their medication. There's good checks and balances in place to manage that.
PE: It seems like you're really talking about giving the pharmacist, with these particular drugs, an increased role.
BS: Today there really is a de facto third class [of drugs]. You have pseudoephedrine behind the counter, you have Plan B behind
the counter. So there is a precedent for behind-the-counter. Will the new FDA leadership push for a behind-the-counter class?
It's too early to tell. But I think if the industry moves toward a third class of drugs, the pharmacists will play a more
important role. My grandfather was a pharmacist, and he was very involved with the patients who came into the pharmacy; he
knew them by first name, and helped them treat their conditions.
I'm not suggesting that we're going to go back all the way to compounding drugs behind the counter again, but I think that
pharmacists have historically played a more active role than they do today—and there's probably a bigger role for them in