Should U.S. programs switch to TB generics?
March 1, 2000
Should U.S. programs switch to TB generics?
Quality shouldn’t be an issue, expert says
Here’s a quick question for TB programs that are pinching pennies: Do you like paying top dollar for drugs, or does the idea of paying 20 to 50 times less than the going rate sound appealing?
The interrogator isn’t a shifty-eyed used car salesman, but rather a drug-policy analyst who thinks U.S. TB control programs aren’t especially smart shoppers when it comes to buying TB drugs.
"Since the 1980s, prices of TB drugs that are off patent have been increasing in the United States at a dramatic rate; the result is that now, U.S. prices are anywhere from 20 to 50 times higher than the generic equivalent in the world market," says Richard Laing, PhD, associate professor in the School of Public Health at Boston University and a speaker at the recent Vancouver conference of the International Union Against Tuberculosis and Lung Disease.
The principal reason, Laing thinks, is simply that American customers seem willing to keep buying at American-style prices, so international manufacturers don’t bother to pursue the U.S. market. "State public health departments purchase in the U.S., and they aren’t looking internationally," he says. "International manufacturers don’t consider the U.S. for that reason. The result is that the U.S. is paying far and above the true price for both first- and second-line TB drugs."
Overseas drug makers in India or Korea, where a robust generic industry has sprung up, are probably reluctant to register their products here because the cost of registering a drug runs to about $10,000. But if public health programs banded together and formed a procurement pool, there would certainly be a big enough market to justify the cost. Plus, Laing suggests, purchasers or even governments could decide to refund the fees once registration is complete.
Nor should issues related to quality and bioavail ability be a sticking point, Laing says. For example, the International Dispensary Asso ciation (IDA), a humanitarian agency based in Amsterdam, has bought and distributed generic drugs for developing countries for the last 25 years with no ill effects. "The IDA has a very good quality-assurance program, with pharmacists who go out and visit factories twice a year," he says. "A lab in Amsterdam does the quality-assurance testing." Could not the same sort of arrangement work for U.S. purchasers as well?
The notion strikes Walter Q. Paige, executive director of the National TB Controllers Associa tion, as one worth pursuing. After all, some U.S. TB programs already have allied to form drug procurement groups, he notes. In addition, as Laing notes, some generic TB drug manufacturers abroad already are registered in the United States, though only as suppliers of raw materials so far. Unless they’re inspired by what Paige calls a "buy-America" sentiment, there’s no obvious reason for programs not to shop elsewhere, he adds.
Paying retail prices isn’t the only nutty aspect of TB programs’ drug-buying habits, Laing says. Why, for example, don’t all programs switch at once — as the IDA did long ago — to buying only combination-tablet formulations? Such a move would work for the better, especially abroad because problems in drug supply no longer would result in patients taking just one drug but not the other or others. That, in turn, would help diminish the creation of new drug resistance, Laing says.
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