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July 8, 2005
The Honorable William H. Frist, M.D.
United States Senate
Washington, DC 20510
Dear Majority Leader Frist:
Consumers Union, the non-profit publisher of Consumer Reports, strongly supports your call for a two-year moratorium on new drug advertisements and your request for a General Accountability Office (GAO) study of the issue.
We share your concern about the impact of these advertisements on the rapid inflation in cost and utilization of pharmaceuticals. We are also concerned that many new drugs have not been adequately tested on a large enough population to know the true dangers associated with the product. These new drugs therefore should not be widely advertised– until we know more about their safety. Attached is a February 2003 article from Consumer Reports that cites many of the problems relating to direct-to-consumer (DTC) advertising of prescription drugs.
The current Food and Drug Administration process of monitoring drug advertisements does not appear to be working well. Drug companies issue misleading ads, but the FDA generally fails to respond or take action until after the advertising campaign has ended. In just one recent example, the FDA told Eli Lilly and Company to stop running a television ad for Strattera (an ADHD drug) on June 14, even though the company’s ad campaign had stopped on May 22.
In addition, many companies have been cited repeatedly for advertising violations relating to the same drug, and often times the nature of the violation is the same. For example, a June 29, 2005, FDA warning letter to Endo Pharmaceuticals about its ads for Lidoderm skin patches repeats a warning the FDA issued to the company on November 24, 1999. In the case of Claritin, reports show that the FDA issued approximately 11 warnings over a four-year period – raising questions as to why the company could not manage to develop an acceptable set of advertisements, and why the FDA failed to take stronger action.
It may be useful to request the GAO to also look at how many DTC ad warning letters have been issued after a company had already finished running a misleading ad campaign. It also be might be helpful to know how many duplicate FDA warnings have been issued to the same company.
Another area the GAO may want to examine is the rapidly growing movement toward direct-to-patient advertising via the Internet and e-mail. The June 2005 issue of Med Ad News points out this trend, a sophisticated and targeted method of advertising which may make it that much harder for the FDA to ensure accuracy and clarity of these types of ads.
For these reasons, we believe the FDA needs more authority and resources to ensure that drug advertisements are accurate and not misleading. Senators Grassley and Dodd have introduced legislation (S. 930), endorsed by Consumers Union, that would help reform the pharmaceutical advertising process. We hope that Chairman Enzi and the Senate H.E.L.P. Committee will develop similar legislation in the near future, and we hope you can help ensure that the Senate considers the broader issue of drug safety this year.
Finally, we have included a sample of Consumer Reports Best Buy Drugs project, a free, public-education effort to help consumers, with their doctor, identify the most effective, safe and affordable medications. The reports are based on the Oregon-based Drug Effectiveness Review Project, currently used by 13 states to identify the safest and most effective drugs based on comprehensive analyses of the scientific evidence. Consumer Reports then takes that medical evidence, combined with national pricing data, to produce easy-to-understand reports and ‘best buy’ recommendations to help consumers lower their drug costs without sacrificing effectiveness
To the extent that we can encourage state Medicaid agencies, Medicare Part D plans, and others to use this evidence-based approach, we can help the American consumer better understand the medicines they take each day, and to question the often-exaggerated and sometimes inaccurate advertisements disseminated by many in the pharmaceutical industry.
Thank you again for your leadership on this issue.
Senior Policy Analyst