Direct-to-consumer (DTC) advertising of prescription medications has been an issue since the late 1990s when the large pharmaceutical companies greatly increased their DTC advertising of their new drugs. Prior to the 1990s, the drug companies mainly focused their marketing efforts on those who prescribed drugs for consumers, i.e., physicians.
In 1997, FDA guidelines regarding DTC advertising were finalized regarding TV and radio advertising of drugs. The intended purpose of the guidelines was to assist consumers by making them aware of new drugs and to encourage them to visit their physicians to obtain further information regarding the new drugs.
The guidelines helped DTC advertising to increase to $4.7 billion in 2008, which was almost 25% of all money spent by drug manufacturers on drug promotions. Most of the promotional money was spent on new drugs, which raises some concerns because adverse effects, side effects, and other potential safety concerns of new drugs may not show up in the smaller-scale testing but may show up when larger numbers of people begin using and continue using the new drugs. Another concern is that heavily DTC advertised new drugs will increase the costs of the new drugs and/or increase the use of the new drugs that may not be more beneficial or only marginally more beneficial than older, less costly drugs used to treat the same ailments. In light of these and other concerns it has been suggested by some that drug companies not be allowed to promote new drugs directly to the public for at least two or three years after the FDA approves the new drugs for sale. However, a counter-argument is based upon studies that found that DTC advertising has caused consumers to seek medical treatment when they might not otherwise and that DTC advertising may also improve consumer drug compliance.
The Congressional Budget Office (CBO) has studied some of the issues of DTC drug advertising by looking at 366 brand-name drugs that were promoted to physicians and other health care providers during the first two years after the FDA approved the drugs for sale. Of the 366 brand-named drugs, 73 were also DTC advertised. The drug companies spent on average $71 million on DTC advertising for the 73 drugs during the first two years after FDA approval. For the 366 drugs, the drug companies spent on average $54 million to promote the drugs to physicians and other prescribing health care providers during the same two year period, and the average number of prescriptions written for newly-approved brand-name drugs with DTC advertising was 9 times greater that the average number of prescriptions written for newly-approved brand-name prescriptions without DTC advertising. There appears to be strong evidence that drug companies spend much more money on DTC advertising new drugs than they do on promoting new drugs to physicians and other prescribing professionals.
Drug companies often justify DTC advertising of new drugs by stating that such advertising permits consumers to become more aware of their drugs and thereby schedule a visit with their physicians to discuss whether the new drugs would be appropriate for them. Studies have shown that the top-selling drugs are frequently among the drugs with the largest amounts spent on DTC advertising. And the sales of drugs with DTA advertising were greater than the sales for brand-name drugs without DTC advertising (between 2004 and 2008, the brand-name drugs with DTC advertising that were studied by the CBO had on average nearly 14 times more prescriptions written annually than the brand-name drugs not DTC advertised).
Between 2004 and 2008, there was a declining number of brand-name prescriptions and also a declining share of the prescriptions representing new drugs (new drugs accounted for 7% of brand-name prescriptions in 2004 but less than 2% in 2008 — the brand-name drugs studied by the CBO showed a decline in the total number of prescriptions from about 1 billion in 2004 to about 700 million in 2008 while the total number of prescriptions for generic drugs increased greatly — the number of newly-approved brand- name drugs without DTC advertising fell from 19 million in 2004 to 5 million in 2008 and the number with DTC advertising fell from 61 million in 2004 to 7 million in 2008).
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