Pharmaceutical firms call a short truce in legislative battle over substitution
Pharmaceutical firms call a short truce in legislative battle over substitutions
Medicare drug benefit proposals more pressing
Regulating the use of brand-name pharmaceutical drugs, particularly those touted as having a narrow therapeutic range of effectiveness, promised to be one of the burning issues of the 1999 spring legislative season. As state legislatures wind up their 1999 sessions, though, the parties to the would-be legislative duel seem to have moved on, at least temporarily.
"We have found that we are able to educate legislators," says Carol Cox, spokeswoman for generic pharmaceutical manufacturer Barr Laboratories in Pomona, NY.
In late fall, Barr representatives were girding for legislative catfights to maintain or ease the use of anticoagulant warfarin sodium, generic for DuPont Pharmaceuticals Co.’s Coumadin. But for the fiscal year that ended in March, Barr reported that its $1.2 million in "government affairs" expenses was a decline of 14% over the previous year. The company says the decline is directly related to a lower-than-expected number of legislative battles where DuPont Pharmaceuticals has attempted to prevent generic substitution of Barr’s warfarin sodium.
Barr fought over warfarin sodium in about 30 states during the 1997 legislative session, around 15 in 1998, and fewer than 10 in the current year, Ms. Cox says.
The main pharmaceuticals industry lobbying group, the Washington, DC-based Pharma ceutical Research and Manufacturers of America (PhRMA), confirmed the slowdown in state activity over so-called "narrow therapeutic index" (NTI) drugs. Proposals to expand prescription drug benefits under Medicare may have diverted some of the attention away from the NTI drug issue, says PhRMA assistant general counsel Marjorie Powell.
One exception is Massachusetts, where Ms. Powell in late June monitored a spirited committee debate on a proposal to define and regulate the distribution of NTI drugs. The bill, HR 1935, would require the prior consent of the physician and patient before a pharmacist could substitute between the generic and branded version of warfarin sodium and five other products.
"So it appears things are not totally dead in the states," Ms. Powell says.
$500 million at stake
The shift in focus away from the NTI issue in state legislatures may favor the generic firms, because much of the legislative activity in recent years was initiated by brand-name pharmaceutical companies. Mean while, DuPont Pharmaceuticals is maintaining its efforts to protect Coumadin—which brings DuPont $500 million annually in revenue—and its other products. At least part of the company’s strategy will be to make it more difficult for pharmacists to substitute drugs at the point of purchase, regardless of whether the prescribed drug is generic or a branded product, says Thomas Barry, a spokesman for the Wilmington, DE-based company.
"This is not a branded vs. generic issue," he says. "The relevant issue is keeping people on the same product."
Contact Ms. Cox at (914) 348-6808, Ms. Powell at (202) 835-3592, and Mr. Barry at (320) 992-5020.
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