The U.S. - one of only two countries in the world that allows direct-to-consumer advertising of prescription drugs (New Zealand is the other and it is reconsidering) - is poised for Congressional battles over those ads.
The New York Times reports: "Drug advertising aimed at consumers, a fast-growing category that reached $4.5 billion last year, will face hard scrutiny in the new Congress, according to industry critics in both the House and Senate.
The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.
The pharmaceutical industry, which often gets what it asks for from Congress and the executive branch, seeks to renew the law and add a new set of user fees that would be pay salaries for additional F.D.A. employees to evaluate all consumer drug ads, before they are shown on television.
Both the industry and its critics agree that there should be a pause before the advertising starts — to allow time for doctors to learn about a new drug. The companies want the delay to be left up to them, but critics say the F.D.A. should require a wait of up to two years. Criticism of direct-to-consumer advertising has intensified since 2004, after Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.
'From the beginning , everyone, including the company, agreed that not everybody ought to be getting Vioxx,' said Helen Darling, president of the National Business Group on Health, an organization of large employers. 'But the ads implied there was a widespread need for it.' "
Posted by schwitz at January 23, 2007 09:00 AM | TrackBack