Otsuka Canada Pharmaceutical resolved generic drugs problem
Topics: OTSUKA CANADA PHARMACEUTICAL DRUG
This is the second time the Bureau has looked into branded pharmaceutical companies' refusals to supply samples of brand name drugs - also known as Canadian Reference Products (CRPs) - to generic manufacturers.
The Bureau launched this inquiry shortly after receiving a complaint alleging that Otsuka restricted a generic drug manufacturer from accessing samples of its branded product, Jinarc. The complaint alleged that actions by Otsuka prevented or delayed the entry of competing generic drugs to the market.
Shortly after the launch of the investigation and after the Bureau applied to the Federal Court for an order requiring Otsuka to produce information, Otsuka provided a supply of Jinarc to the generic manufacturer, and in doing so, resolved the Bureau’s concerns.
The Bureau remains very concerned that this sort of conduct has persisted despite its previous investigation and guidance to the pharmaceutical industry.
Branded drug manufacturers should be aware that the Bureau will treat any explanation for a failure to supply CRPs in a timely manner with an extremely high degree of skepticism. Even if CRPs are eventually supplied after an initial delay, the Bureau will take the necessary steps to address past anti-competitive conduct, including seeking administrative monetary penalties. ■