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FDA investigates 'distracting' images on TV drug commercials

The FDA has revealed it will investigate images used in US television advertisements for drugs to see if they distract consumers from warnings about potential risks.

The FDA has revealed it will investigate images used in US television advertisements for drugs to see if they distract consumers from warnings about potential risks.

The FDA announced their intention on their website and the investigation was probably prompted by a study published in the New England Journal of Medicine (NEJM), which suggested the FDA's direct-to-consumer (DTC) drug advertisement enforcement activities had steadily declined.

The website message says the FDA will examine how 2,000 people react to drug commercials to see if they have a biased, positive impression of products.

In the US, it is a legal requirement that pharmaceutical companies present a balanced picture of a treatment's benefit and risk in television commercials. However, some critics of DTC advertising accuse companies of using overly positive images of fictional people using a treatment to distract from audio warnings about complications. Critics say that in order to achieve a balance, images of the side effects should be shown.

The original NEJM article, which revealed the downturn in FDA scrutiny, claimed the agency sent only 21 warnings to drug companies about misleading DTC adverts in 2006, compared with 142 in 1997. In the same period, spending by the pharmaceutical industry leapt 330 per cent to USD 29.9bn in 2005 from USD 11.4bn in 1996.

The FDA admits that a study is needed to see if some commercials "distract consumers from carefully considering and encoding risk information".

The Pharmaceutical Research and Manufacturers of America (PhRMA) has already issued voluntary guidelines for members on promoting medicines to patients. The guidelines suggest that companies submit television commercials to the FDA for review before they are broadcast to the public. In response, the industry has agreed to pay the FDA USD 80,000 for each commercial to help finance the cost of hiring extra reviewers.

Despite this proposed arrangement, the US Federal government rejected the proposal saying that the FDA finance the regulatory reviews itself. The reasoning behind the block was that if pharmaceutical companies paid for the hiring of FDA reviewers, this could create a conflict of interest situation.

In September 2007, a meeting is scheduled between the Senate and the Lower House to discuss bills that would increase the FDA's DTC enforcement powers.

 

22nd August 2007

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