Anglo-Swedish drugmaker AstraZeneca has submitted a proposal to the US Food and Drug Administration (FDA) suggesting that all direct-to-consumer advertisements should undergo a review and receive approval by the agency, before they can be shown to the public.
The company made its proposal in written testimony during a two-day FDA advisory committee meeting on DTC advertising.
AstraZeneca said it already applies its own set of in-house guidelines on DTC advertising, and also complies with the principles set out by US Industry body the Pharmaceutical Research and Manufacturers of America (PhRMA), which are due to come into effect early next year [[23/08/05b]] [[25/07/05b]]. PhRMA’s guidelines stop short of asking for an FDA review of each advertisement, though, and are based on discussions with physicians before the launch.
“The PhRMA guidelines are a solid first step, but the proposals we're making today make clear that AstraZeneca views the PhRMA principles as a floor, not a ceiling," said Tony Zook, senior vice president, commercial operations, for AstraZeneca Pharmaceuticals in the USA.
AstraZeneca’s proposals would require all DTC advertisements t be reviewed, but only if the FDA has resources available to deliver a verdict within a specific timeframe.
The Industry has been prompted into action on DTC advertising by criticism of its past practices, and is now seeking to put its house in order before any drastic measures, such as a ban on the practice, are set in place. In the USA, House Majority Leader Bill Frist called in July for a two-year moratorium on advertisements for new drugs because it caused ‘inappropriate prescribing’ and could put patient safety at risk [[04/07/05c]]. Meanwhile, there have been a number of cases where companies have been found to have overstepped the mark in campaigns [[18/04/05c]].
Consumer groups in the USA are also gunning for the Industry on the DTC advertising issue, insisting that there needs to be a way to enforce standards by law. In the meantime, they have taken the mater into their own hands; last month a group of consumer bodies, along with a union health plan, filed a lawsuit against Pfizer alleging that it had mis-promoted cholesterol-lowering drug Lipitor (atorvastatin) to patients who have not been proved to benefit from the product [[30/09/05c]].
In an interview with the Financial Times, AstraZeneca chief executive David Brennan said the company had already shifted the emphasis of its advertising towards patient education and away from branding, but he insisted that voluntary measures to prevent mis-promotion should be tried in the USA before any legislative change is undertaken.
IMS Health estimates that, in 2004, drugmakers spent an estimated $4.15 billion on DTC advertising.
Meantime, AstraZeneca said it has committed to fund the first large-scale consumer research study on the use of fair balance in television commercials. Results are expected to be available to the public in early 2006.