US drug industry's guidelines on advertising too limited, say critics
BMJ 2005; 331 doi: https://doi.org/10.1136/bmj.331.7514.420-b (Published 18 August 2005) Cite this as: BMJ 2005;331:420Data supplement
US drug industry’s guidelines on advertising are too limited, say critics
Canberra Bob BurtonIn the face of growing support for tighter regulations on advertising directly to consumers, the US drug industry’s trade association has released voluntary guidelines of its own.
However, the guidelines fall short of a proposal by the leader of the Republican Senate majority, Bill Frist, for a two year waiting period before any new drug can be advertised directly to consumers. In July Dr Frist told the Senate that "if drug companies don’t clean up their act, I believe Congress will need to act in this arena."
The 15 point guidelines released by the Pharmaceutical Research and Manufacturers of America (PhRMA), which are scheduled to take effect in January 2006, propose that signatories "should spend an appropriate amount of time to educate health professionals about a new medicine or a new therapeutic indication before commencing the first DTC [direct to consumer] advertizing." Bristol-Myers Squibb has opted for a one year waiting period and Pfizer six months.
The trade association will refer any complaints over compliance with the code to the sponsoring company. PhRMA says it will release "periodic" reports on the "the nature of the comments and the signatory companies’ responses."
While Dr Frist said the guidelines should have "gone further," Rob Schneider, the director of a prescription drug reform project of the Consumers Union, said they were designed "to pre-empt Congress requiring the Food and Drug Administration to do significantly more on safety and transparency and consequently requiring more disclosure in any advertising."
"Legislation before the house proposes much tougher restrictions on new drugs and drugs with outstanding post-market approval studies that have not yet been completed," Mr Schneider said. A Food and Drug Administration spokesperson told the Washington Post that the agency would review its current policy on drug advertising. The American Medical Association was unavailable for comment.
In Australia, where direct to consumer advertising is banned, the Australian drug industry’s voluntary code covers unbranded "disease awareness" advertising. However, despite providing for fines of up to $A200 000 (£85 000; $154 000; €125 000) and the expulsion of signatories, the code has been criticised by health professionals.
Last month the code of conduct committee of Medicines Australia, the group representing the country’s drug manufacturers, found that seven advertisements placed by six companies in Australia’s most widely used prescribing software breached the standards. Ken Harvey, a senior lecturer at the School of Public Health at La Trobe University, Melbourne, first raised questions about the advertisements (BMJ 2005;331:177, 23 Jul).
Most of the offending companies were directed only to revise the advertisements. "Companies can make millions from selling drugs, but when their advertising is found to be in breach of the code they escape without penalty," Dr Harvey said.
"I was prepared to give a voluntary code the benefit of the doubt, but it must be judged against some minimum performance standards. It is time it was abandoned as an experiment that failed and regulatory measures introduced," he added.
PhRMA’s Guiding Principles: Direct to Consumer Advertisements About Prescription Medicines is accessible at www.phrma.org
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