A Survey of Drug Products Removed from the Market

Abstract

A survey of drug product removal from the market was conducted for the years of 1980-1984 covering 24 firms and 95 products. the questionnaires were mailed to 46 firms and covered 200 products, 152 single entities and 48 combination products. Useable responses included 71 single entities and 24 combination products. the percentages of mode of product approval for the final sample were NDA 50%; ANDA, 16%, and grandfather clause, 34%. the mean life span was 20.4 years. the primary reasons for removal of the products were economic, 65%; regulatory, 27%, and other, 8%. There was a significant difference in the approval modes and a marginally significant difference for the reasons of product removal from the market for the two product types. the reason for product removal was different for products approved under the three modes of approval, but this was only marginally significant statistically. the X² test was used for these determinations. More drug products were removed from the market than were added during this time period.

A mail survey of 46 firms covering 200 products yielded responses from 24 firms (52%) and 95 (48%) products. Most of the products removed from the market had been approved under the NDA process (50%) and a lesser number under the ANDA process (16%) and grandfather clause (34%). More combination products were approved under the grandfather clause. the range of life span for the products was 2-49 years with a mean of 20.4 years. Proportionally, more combination products were removed from the market for regulatory reasons and more products approved under the ANDA or grandfather clause were removed for economic reasons. Firms are reluctant to remove products from the market even after they cease to be profitable.