Brand drug companies impeding generic drug company access to product samples: Estimated prevalence and impact on drug costs

Abstract

Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.