AARP Submits Testimony On DTC Advertising

Main Category: Seniors / Aging
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 12 May 2008 - 6:00 PDT

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Controlling direct-to-consumer (DTC) advertising of prescription drugs has an important role to play in making prescription drugs more affordable for the overall U.S. health care system.

A recent AARP study revealed that, on average, pharmaceutical manufacturer prices for the 220 brand name drugs most widely used by older Americans rose at more than two and one-half times the rate of general inflation in 2007.

Increased spending on prescription drugs is due, in part, to the increase in direct to consumer advertising. In recent years, according to IMS Health, the amount of money spent on direct-to-consumer advertising of prescription drugs has increased rapidly: $4.8 billion was spent in 2006, an over 400% increase from the $1.1 billion spent in 1997, when the FDA first relaxed its guidelines for broadcast advertising.

Overall health care costs increase when patients are prescribed - often unnecessarily - new, heavily-advertised pharmaceuticals as the first-line therapy, rather than older, equally effective but often less-expensive medications.

Many advertisements do not make the drug's safety, use, and efficacy clear. Older consumers are concerned about the value of prescription drugs and would appreciate information regarding the effectiveness of the medication. The most effective ads are those that teach and educate older consumers about a specific condition and that urge a dialogue with their physician.

Direct-to-consumer advertising of prescription drugs can be helpful to consumers to the extent ads provide general information about a specific disease or condition, particularly one that is historically under-diagnosed and/or undertreated (e.g., "help-seeking" advertisements).

Direct-to-consumer advertisements should inform the consumer and provide clear, accurate information. They should also encourage the consumer to have a productive dialogue with their provider about their treatment options, including prescription and non-prescription medicines, generic alternatives, and lifestyle changes, if applicable.

AARP believes that the Congress should examine the benefit of requiring a two-year moratorium on DTC advertising to consumers on all newly-approved prescription medicines. This would permit the FDA to accumulate and evaluate post-marketing safety data based on general population use of the product before it is more broadly advertised to the general public.

AARP believes that the FDA should be granted the authority to mandate that all drug advertising should be subjected to prior approval by the FDA. We would like to see the FDA, working in consultation with other interest groups (including consumers and providers) revise its "Guidance for Industry: Consumer-Directed Broadcast Advertisements" to ensure that advertisements provide clear and accurate information to consumers.

In addition, AARP believes that direct-to-consumer advertising should convey both risk and benefit information -- simply directing DTC viewers to the Internet and magazines for "additional information" is not always practical.

Finally, AARP believes that the U.S. health care system can benefit from a more serious investment in research of comparative clinical effectiveness of prescription drugs.

[I]mproved FDA oversight of DTC advertising would promote better - and often less costly - use of prescription drugs. While AARP will continue to examine how DTC can best educate and inform consumers and health professionals, we will also pursue other ways to promote appropriate and cost-effective prescribing to help consumers make wise choices about their medicines.

http://www.aarp.org