By Helen Mooney
1 London
The head of the panel that monitors the marketing of drugs in the United Kingdom has defended its system of regulation as being "very strong," despite persistent offences by one company.
Procter & Gamble Pharmaceuticals UK was reprimanded in October 2009 for breaching the voluntary code of practice of the Association of the British Pharmaceutical Industry for using marketing material with the strapline "Confidence in colitis." However, the Prescription Medicines Code of Practice Authority, the arm’s length body that enforces the code of practice on behalf of the association, had to take action against Procter & Gamble again this monthover the same offence.
Heather Simmonds, the authority’s director and chairwoman of its code of practice panel, told the BMJ that sanctions levied against drug companies that breached the code were "very strong."
She said that Procter & Gamble voluntarily admitted that it was in breach of the code a second time. "The second breach of code was down to human error and was not acceptable. This led to us issuing a clause 2 ["bringing discredit upon and reducing confidence in the pharmaceutical industry"] sanction and advertising the details of the breach. The original sanction led to the company having to withdraw the material it had produced as well as it bearing the cost of having to fix it," she said.
Solvay Healthcare and Pfizer were also found to have breached the code.
The authority found that Solvay failed to ensure that grants given as a cheque to a GP to carry out an audit of patients’ cardiovascular risk factors and review their long term management constituted a "bona fide" medical and educational good. It said that the company had given the doctor an "inducement to prescribe" Omacor, a preparation of omega 3 acid ethyl esters used to regulate blood lipids.
The authority also concluded that Solvay had brought discredit on and reduced confidence in the drug industry, and the company has been publicly reprimanded by the authority’s code of practice appeal board.
Pfizer was found to have made misleading claims about the nicotinereplacement treatment varenicline (marketed as Champix) that it could not substantiate. The authority said that Pfizer had made claims and comparisons that were misleading and not sufficiently complete for readers to form their own opinion of the drug’s therapeutic value, had used data that could not be substantiated, and had failed to maintain high standards.
Under provisions in its constitution and procedure the authority advertises brief details of all cases where companies have been ruled in breach of clause 2 of the code. Companies are also required to issue a corrective statement or are the subject of a public reprimand. The advertisements publishing these breaches appeared in the 10 April print edition of the BMJ. Solvay has also been publicly reprimanded.
Ms Simmonds claimed that these actions were sufficiently damaging to companies to deter them from breaching the code. She said, "A major sanction on pharmaceutical companies is the detailed publication of the outcomes of the case and in some cases the advertising of these cases; this has a serious affect on reputation. In the UK we publish much more detail of cases than in other countries and this is much more effective."
Drug companies are not subject to fines for breaching the code of practice in the UK, unlike in the United States, but Ms Simmonds said that the publication of the findings of the cases "does really hurt."
"Publicising the outcome can affect share price and dealings with other organisations, and it can make a difference to the company’s reputation with clinicians," she said.
Cite this as: BMJ 2010;340:c1970
The full case reports are available at www.pmcpa.org.uk.
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