Janssen-Ortho Inc. and the Patented Medicine Prices Review Board (PMPRB) have reached an agreement to resolve issues involving the price of Risperdal Consta. On June 7, 2007, the PMPRB concluded proceedings commenced in January 2006, by approving a Voluntary Compliance Undertaking (VCU) by Janssen-Ortho

Under the VCU, Janssen-Ortho agreed to a benchmark maximum non-excessive price (MNE) for Risperdal Consta that is significantly below the medicine's introductory price though approximately 50% higher than the MNE initially sought by the PMPRB Staff. Also under the VCU, Janssen-Ortho has agreed to take measures to offset the difference between the prices charged in the past and the new agreed-upon prices by payment of a sum of money for the period of September 2004 to the end of 2006, and will take other measures as necessary to offset any differences in 2007 until the effective date of the price reduction

In the VCU, Janssen-Ortho notes its disagreement with the initial positions of Board Staff and the Board's Human Drug Advisory Panel (HDAP) indicating that Risperdal Consta represents a substantial improvement over existing therapies and it disputed the comparative dosages proposed by the HDAP as being inconsistent with medical practice. Interestingly, Janssen-Ortho notes that Risperdal Consta is priced at a higher level than the comparator medicines proposed by Board Staff in all of the PMPRB's reference countries and that the price initially proposed by Board Staff would have been significantly lower than the lowest price in those countries

This is the second settlement in less than a month announced by the Board. On May 24, it terminated proceedings against 3M Canada Company concerning the price of Airomir (salbutamol sulphate), which is used in the symptomatic management of asthma. In that case, 3M Canada made a VCU to pay approximately $485,000 to the Government of Canada to offset the difference between the actual prices of Airomir and the maximum non-excessive price alleged by Board Staff during the period from 2004 to December 2006. 3M Canada ceased selling Airomir in December 2006 when it sold its rights to that drug to Graceway Canada Company

Of the eight hearings commenced by the Board in the past 18 months, six are ongoing

For more information from the PMPRB on the Risperdal Consta matter, please see:


For information on the Airomir matter, please see:


For the PMPRB's hearing schedule, please see: