Risk-management plans may be a burden for new drug launches, but they're proving to be a weapon against generic competition, too. As the New York Times reports, generics makers can't buy the supplies they need to knock off a product, thanks to REMS restrictions. So, they have to resort to asking branded drugmakers for supplies--and some of those companies aren't cooperating.
Problem is, that practice is illegal, according to the U.S. government. The Federal Trade Commission is going after drugmakers who engage, the NYT reports, by weighing in on one case and investigating others. Swiss drugmaker Actelion won't hand over its lung drug Tracleer to would-be copycats, and generics makers Apotex and Roxane Laboratories have sued--and attracted backing from the agency. Generics maker Lannett settled a similar lawsuit with Celgene ($CELG), which had withheld samples of its blood-cancer drug Thalomid, but now the FTC has stepped in to investigate.
It's just the latest tactic drugmakers are using to block generic rivals as long as possible. For years, drugmakers have filed citizen petitions at FDA to keep copycats off the market, citing everything from proprietary data on drug labels (AstraZeneca and its antipsychotic Seroquel) to the scores on tablets that make them easier to split (Warner Chilcott and its acne drug Doryx). Reckitt Benckiser tried to block copies of its Suboxone addiction drug, citing a need for child-safe packaging on generic versions.
The practice of denying samples is fairly common, according to the Times. Gilead Sciences ($GILD) restricts access to its lung drug Letairis, instructing pharmacies and other customers to refrain from using it in clinical trials without the company's express permission. And industry consultants have cited "life-cycle management" as a benefit of REMS.
Generics maker Apotex offered a couple of examples. The Canadian generics maker says Novartis ($NVS) wouldn't supply its leukemia drug Tasigna until it threatened to sue; Novartis says it was a misunderstanding, and that "generic companies are free to buy Novartis products through distribution channels." Apotex also complained that Lundbeck, the Danish drugmaker, wouldn't provide samples of Xenazine, a Huntington's disorder treatment. Lundbeck, for its part, says it's asking FDA for guidance because it's not clear whether Lundbeck is allowed to sell the drug "to any person or entity without a prescription."
Actelion cited a more fundamental legal reason for denying Tracleer to generics makers. Companies aren't required to do business with generics makers, it says. "This action concerns the fundamental right of a business to choose for itself with whom to deal and to whom to supply its products," the company said in court documents (as quoted by the Times).
- see the NYT story
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