Shire Pharmaceuticals Ltd and Roche Products Limited have each breached the ABPI Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry.
Under provisions in its Constitution and Procedure, the Prescription Medicines Code of Practice Authority (PMCPA) advertises brief details of all cases where companies are ruled in breach of Clause 2 of the Code, are required to issue a corrective statement or are the subject of a public reprimand.
Shire – Case AUTH/2528/8/12
For issuing a press release for VPRIV (velaglucerase alfa) (a prescription only medicine) that was misleading, inaccurate, disparaging, implied statistical and clinical significance from exploratory data and effectively promoted the medicine and encouraged patients to ask their health professionals to prescribe it, Shire was ruled in breach of the following clauses of the Code:
Clause 1.8 - Failing to comply with the Code.
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 4.1 - Failing to include prescribing information in promotional material.
Clause 7.2 - Making misleading claims.
Clause 7.3 - Making a misleading comparison.
Clause 8.1 - Making disparaging claims.
Clause 14.1 - Failing to certify promotional material before issue.
Clause 14.5 - Failing to certify promotional material before issue.
Clause 22.1 - Promoting a prescription only medicine to the public.
Clause 22.2 - Encouraging members of the public to ask their health
professional to prescribe a specific prescription only medicine.
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 4.1 - Failing to include prescribing information in promotional material.
Clause 7.2 - Making misleading claims.
Clause 7.3 - Making a misleading comparison.
Clause 8.1 - Making disparaging claims.
Clause 14.1 - Failing to certify promotional material before issue.
Clause 14.5 - Failing to certify promotional material before issue.
Clause 22.1 - Promoting a prescription only medicine to the public.
Clause 22.2 - Encouraging members of the public to ask their health
professional to prescribe a specific prescription only medicine.
Voluntary admission by Roche – Case AUTH/2582/2/13
Roche made a voluntary admission in relation to the distribution of an uncertified, promotional mailing for an unlicensed medicine. Roche was ruled in breach of the following clauses of the Code:
Roche made a voluntary admission in relation to the distribution of an uncertified, promotional mailing for an unlicensed medicine. Roche was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 3.1 - Promoting a medicine prior to the grant of a marketing authorization.
Clause 9.1 - Failing to maintain high standards.
Clause 14.1 - Failing to certify promotional material before issue.
Clause 3.1 - Promoting a medicine prior to the grant of a marketing authorization.
Clause 9.1 - Failing to maintain high standards.
Clause 14.1 - Failing to certify promotional material before issue.
The full case reports were published in the PMCPA May Code of Practice Review and are also available at www.pmcpa.org.uk.
Under provisions in its Constitution and Procedure, the Prescription Medicines Code of Practice Authority (PMCPA) advertises brief details of all cases where companies are ruled in breach of Clause 2 of the Code, are required to issue a corrective statement or are the subject of a public reprimand.
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