Recent Developments In Pharmaceutical Product Direct To Consumer Advertising

February 2006

In 1997, the FDA changed the rules governing direct to consumer advertising (“DTC”) for pharmaceutical products.  The changes allowed pharmaceutical companies to use television and print ads to inform consumers about their products.  The use of television and print ads came in three forms: 1) Help-seeking ads, which may mention the name of a company but not a particular drug, inform consumers about certain diseases or conditions and recommend seeing a physician; 2) Reminder ads, which mention the name of a particular drug but not any diseases or conditions; and 3) Product claim ads, which name the product and the disease or condition that it is used to treat.  Under current guidelines, reminder and help-seeking ads are not required to contain information about risks associated with a specific product.  On the other hand, product claim ads require a fair balance of risks and benefits associated with the product.   Print product claim ads must inform the reader about the risks associated with the product, while television and radio ads must contain a major statement of all the important risk information related to the product or provide for adequate distribution of this information by referring consumers to websites, print ads or call-in numbers where additional information may be obtained.

With the increase in print and television ads for pharmaceutical products, physicians, consumer watch groups, elected officials, and industry representatives weighed in on the risks and benefits associated with the use of DTC.  Physicians noticed an increase in patients requesting specific drugs for their conditions.  As patients began “self-medicating” by demanding specific advertised drugs, many physicians expressed concern that DTC was disrupting the physician-patient relationship.  For example, a study published in the Journal of the American Medical Association, Vol. 293 No. 16 (April 27, 2005) found that DTC and patient requests for specific drugs had a profound effect on physicians prescribing drugs for major depression adjustment disorders.   At the same time, the study found that DTC averted underuse of drugs for treating the conditions.

Consumer watch groups have weighed in on the risks and benefits of DTC. Proponents of DTC say that it creates more informed consumers, who are able to be more involved and knowledgeable about their health.  In the industry of medical devices and testing, DTC also avoids prolonged periods where the patient has to wait to receive treatment and saves the consumer money by making services and products available directly to consumers without having to go through a physician or hospital.  Opponents of DTC state that it gives patients a false sense of security in the drugs advertised because many consumers believe that the FDA heavily scrutinizes the products that are advertised.  Consumer Reports published an article in its January 2006 issue in which it criticized the role of the FDA in monitoring and reviewing DTC.  In its investigation of regulatory letters to pharmaceutical companies from 1997 through 2005, Consumer Reports found that many ads contained a wide range of misleading and incorrect information, but the number of regulatory letters issued had dropped.  The article also expressed concern that the FDA is understaffed to adequately monitor DTC.  For example, in 2004, the last year analyzed, there were only 40 reviewers covering almost 53,000 promotional materials for drugs.

Elected officials have also weighed in on DTC.  Senate Majority Leader Bill Frist has proposed a two-year moratorium on all DTC.  In addition, in early November 2005, the FDA held a public forum to discuss the risks and benefits of DTC.  Representatives from all facets of the industry were present and participated in the discussions.  Some opponents of DTC recommended solutions from banning DTC altogether to allowing only DTC to take the form of help-seeking ads.  Other groups proposed a two- to three-year moratorium on ads, as well as requiring pre-approval from physicians.

In addition to proponents arguing that DTC benefits consumers, others have expressed concern that banning DTC is censorship directly in violation of First Amendment Rights.  Banning DTC altogether is one more step toward increased censorship and government involvement in the industry.  In fact, the American Medical Association voted at its annual meeting in June 2005 not to support limits on DTC until further study was conducted, in part because of concerns that imposing limitations on DTC would violate First Amendment Rights.  Further, according to industry analysts, it is not unreasonable to conclude that banning DTC could cost the advertising industry over $10 billion.

During the summer of 2005, the Pharmaceutical Research and Manufacturers of America published DTC guidelines for the industry to follow.  As of August 2005, 23 pharmaceutical companies agreed to follow the guidelines.  Many pharmaceutical companies are voluntarily taking further internal steps to address the concern over DTC.  Bristol-Myers Squibb Co. announced in June 2005 that it would implement a one-year moratorium on DTC for its new medications.  In August 2005, officials for Pfizer announced that Pfizer will implement a six-month moratorium on DTC for new medications and will improve information on safety risks in DTC.  Pfizer even issued its own internal guidelines to follow for DTC.  Still, critics of DTC say it is not enough and some continue to lobby for a complete ban on DTC.

Questions and issues continue to be raised and debated on the risks and benefits of DTC.  What is known is that the FDA is looking at the issue more than it has in the past.  It remains to be seen what changes the FDA will implement, if any at all.  In the meantime, many companies concerned about public perception are taking affirmative internal steps to address public concerns and criticisms expressed about DTC.


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