Colonis Pharma has been named in advertisements for breaches of ABPI Code.
Colonis Pharma has been named in advertisements for breaches of ABPI Code.
Press Release 25 September 2020
Colonis Pharma – Case AUTH/3239/8/19
For sending a letter that promoted Melatonin 1mg/ml oral solution for off-label use and prejudiced patient safety, Colonis was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 3.2 - Promoting a medicine for an unlicensed indication
Clause 9.1 - Failing to maintain high standards
Colonis Pharma – Case AUTH/3240/8/19
For failing to identify during the approval process that the incorrect prescribing information had been included in a promotional letter about Melatonin 1mg/ml oral solution, Colonis was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 4.1 - Failing to include up-to-date prescribing information
Clause 9.1 - Failing to maintain high standards.
In addition the Code of Practice Appeal Board(2) required Colonis to be publicly reprimanded for its failure to provide complete and accurate information to the Code of Practice Panel.
Notes to Editors:
The public reprimand and case reports are available at www.pmcpa.org.uk.
For more information contact Elly Button ebutton@pmcpa.org.uk 07920 863650
(1) The advertisements will appear in the British Medical Journal and the Pharmaceutical Journal on 26 September 2020 and the Nursing Standard on 30 September 2020.
(2) The Code of Practice Appeal Board consists of an independent, legally qualified, chairman and includes independent members, as well as senior executives from pharmaceutical companies. For the consideration of any matter independent members, including the Chair, must be in a majority. Further details are available in the PMCPA Constitution and Procedure.
The Prescription Medicines Code of Practice Authority (PMCPA) was established by The Association of the British Pharmaceutical Industry (ABPI) to operate the ABPI Code of Practice for the Pharmaceutical Industry independently of the ABPI. The PMCPA is a division of the ABPI. The Code covers the promotion of medicines for prescribing to health professionals and the provision of information to the public about prescription only medicines. If you have any concerns about the activities of pharmaceutical companies in this regard, please contact the PMCPA at 7th Floor, 105 Victoria St, London, SW1E 6QT or email: complaints@pmcpa.org.uk. The Code and other information, including details about ongoing cases, can be found on the PMCPA website:www.pmcpa.org.uk.
The PMCPA is a division of the ABPI which is a company limited by guarantee registered in England & Wales no 09826787. Registered office 7th Floor, Southside, 105 Victoria Street, London SW1E 6QT.