"Levulan as manufactured by Dusa Pharmaceuticals meets very strict guidelines. But many people are using compounded aminolevulinic acid (ALA) and telling patients they're getting Levulan," says Vic Narurkar, M.D.
When he treats patients with the real thing, he adds, they quickly realize they'd previously been cheated.Dusa has been aware of the compounding problem for about three years, reports Scott Lundahl, the company's vice president of regulatory affairs and intellectual property.
"We find there's a lack of education in the medical community about some of the issues associated with compounding, with respect to both quality issues and Dusa's patent position," he says.
In fact, he says some physicians actually tell Dusa's sales force they're using compounded products. "Another way we learn about them is through promotional materials distributed by compounding pharmacies, which should know better," Mr. Lundahl adds.
Most compounding pharmacies appear to respect Food and Drug Administration's (FDA's) position on compounding commercially available pharmaceuticals, he says. However, he states, "There are a number [of pharmacies] that seem to make their business out of essentially knocking off other people's products."
While such pharmacies know Levulan's active ingredient, adds Mr. Lundahl, "They don't necessarily know what's in the vehicle, so they make up their own formulation. Not only that, but it's not clear where a lot of compounding pharmacies are getting their ALA," which creates concerns for purity and potency.
Fortunately, he says, "Levulan has an extremely safe product profile. It's very difficult to induce serious harm with the drug," although he's heard of occasional burning and peeling reactions to compounded Levulan.
Patients recover from these mishaps, says Mr. Lundahl, "But does one really want to put patients in that position in the first place?"
Due to the nature of Dusa's patent (method of use), he says the company's battle against illegal compounding sometimes begins at the physician level. "We want to educate the medical community" about concerns including compounded pharmacies' lack of quality control. "That can give one's product a bad reputation," Mr. Lundahl states, "even though one had nothing to do with it."
Simultaneously, he says, "We're going after the compounding pharmacies and the manufacturers that supply them." At press time, the company had reached a settlement with one such supplier, he adds. FDA also has sent a warning letter to this company.
Furthermore, although Dusa prefers not to sue doctors, Mr. Lundahl says, "There are times when we have no choice." More specifically, he says the company has prevailed through settlements in each of the dozen or so cases it has pursued.
"FDA has been working on the compounding issue for quite some time because they basically agree with us" that compounding pharmacies must not overstep their bounds and become small-scale drug manufacturers, Mr. Lundahl says.
But while the FDA's efforts have yielded a mixed bag, he says Dusa's education and patent enforcement efforts are "definitely making progress."
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