The QMN Weekly Bulletin

GMP violations and recalls that have mounted over the past 18 months have hurt the industry’s image, Doug Boothe, CEO of the U.S. unit of Actavis, recently told the Generic Pharmaceutical Association’s Annual Policy Conference. The industry is speeding the entry of generics into the market by increasing the number of Paragraph IV challenges against weak innovator patents — from 35 in 2001 to 165 in 2008, Boothe said.

He referred to his own company’s problems, including recalls involving products manufactured at its plant in Little Falls, N.J., and a number of incidents involving other generic-drug makers.
Drug GMP Report