DTC advertising to be tightened up
pharmafile | August 4, 2005 | News story | Medical Communications |
New US guidelines for pharmaceutical DTC advertising will come into effect next year as the industry seeks to address public concern over its advertising practices.
Millions of dollars are spent promoting drugs to US consumers but the fallout from Merck's withdrawal of its painkiller Vioxx last year, one of the most heavily promoted drugs, strengthened fears over patient safety.
Now pharma companies will avoid some of the highest profile television advertising spots in the US, including the next Super Bowl, in a bid to restore public confidence and avoid the threat of a complete ban on DTC advertising.
The voluntary Guiding Principles have been produced by US industry association PhMRA and have the backing of most of the big pharma companies, including Pfizer, Merck, Sanofi-Aventis and AstraZeneca. A number of companies have also indicated their intentions to go further than the new guidelines require.
The new guidance is more stringent than current requirements, though being a voluntary code it lacks a legislative basis, but has been dismissed by industry critic Public Citizen as dangerous and doomed to failure.
It comes into effect in January next year and covers all DTC television and magazine ads. The main points are:
DTC ads must responsibly educate consumers about the medicine and, where appropriate, the condition it was prescribed for, instead of just being used to market drugs
- Pharma companies must spend an appropriate, though undefined, amount of time educating health professionals about new medicines or indications before starting a DTC campaign
- If a product is mentioned by name the ad should clearly state the conditions it is indicated for and any major risks associated with taking it.
- Ads must show a drug risks and benefits in a balanced way
- Ads should be targeted at an audience of an appropriate age
The guidance does not apply to any of the sponsorship activities that pharmaceutical companies engage in and is not so strict as to stifle the industry.
The principles will compel companies to submit all of their new DTC television ads to the FDA for the first time. Currently they only have to do this if requested by the regulators. Existing television DTC ads that have been significantly changed will also have to be sent to the FDA.
Timothy Rothwell, president and chief executive of Sanofi-Aventis in the US, said: "Overall, DTC advertising has been beneficial to both patients and physicians. Can we do it better? Yes. And that's what the guidelines are all about."
PhRMA will set up a new department to receive comments from members of the public and healthcare professionals on any ads by companies that sign up to the new code.
AstraZeneca established its own internal guidelines for DTC advertising early last spring and Merck has a long-standing policy to voluntarily submit new DTC advertising to the FDA for review and comment. Meanwhile, Bristol-Myers Squibb pledged in June to observe a stricter code of conduct in the promotion of its products.
In light of the new guidance Pfizer and Lilly will not advertise Viagra and Cialis, their respective treatments for erectile dysfunction, at the 2006 Super Bowl, in order to avoid programmes considered to be family viewing.
Pharma companies that sign up to the new code will have to send copies of it to their advertising agencies and distribute them internally.
Related articles:
Bristol-Myers Squibb to limit direct to consumer advertising
Wednesday, June 15, 2005
