Solution One: Keep the status quo including the requirements of the 1997 "Draft Guidance for Industry and FDA." 

As stated before, many believe that the 1997 interpretation was an improvement over previous standards, and they may be right.  Nonsensical  reminder ads are certainly not as informative as product claim advertisements, which list some of a drug's benefits and risks.  The benefit, therefore in the current regulations is an increase in information.

The cost, however seems to outweigh the benefit.  The 1997 "Draft Guidance" allowed more information to be presented to the consumer.  But this increase in information does not currently seem to be resulting in a benefit to consumers, and certainly not to the patient-physician relationship.  Leaving the current regulations as they are may solve the problem created by a saturation of reminder ads, but it does nothing to address the current problems resulting from such regulations.  Simply allowing for more information to be provided to the consumer does not guarantee that this information will result in a benefit.  An increase in information is not a benefit for consumers if it results in misunderstandings and confrontations with physicians.  Keeping the current regulations, while clearly achievable, does not address the problems created by its implementation.  There is no reasonable  guarantee, or even probability, that such a solution would achieve the stated goals.

Solution Two: Create a mandatory testing policy for DTCA.

A mandatory testing policy for DTC ads would be a major step towards guaranteeing that the ads result in an informational benefit to consumers, and the patient-physician  relationship.  The 1997 "Draft Guidance" emphasizes DTCA regulations with vague language.  It requires that ads (1) "are not false or misleading in any respect," (2) "present information about effectiveness and information about risk in a balanced manner," (3) convey "all of the [drug's] most important warnings, precautions, side effects, and contraindications  in a consumer-friendly-language.[1]  The "Draft Guidance," along with the FDA, however, have provided very few specific definitions for things like "consumer-friendly language," and "balanced manner."  It must be assumed then that the FDA's purpose within this language is to guarantee that the information presented in DTC ads is understandable and accurate for the consumer.  The problem, however, is that no system or specific guidelines exist to make this guarantee.  Without such a system, the FDA is carelessly assuming that the consumer does understand the language within DTC ads, and that it is being received in a fair and balanced way.

A system based on Ethicad's guidlines, whereby DTC ads could be tested in order to guarantee their ability to fall within these regulations would help to ensure that information within DTC ads is beneficial.  Advertising standards could be created by the FDA, in which all DTC ads are required to be tested by FDA approved consumer and physician focus groups.

This solution is also extremely feasible.  In 2000 the drug companies spent $2.5 billion on advertising, a figure that has steadily risen.[2]  A substantial portion of this money is used to test the ad's effectiveness, a normal procedure in large advertising campaigns.  This solution would simply require some FDA oversight into this process.  In addition to meeting current FDA regulations, the ads would have to be tested by FDA approved groups.

The major obstacle to this solution is that a program such as this would require the passing of an amendment by Congress to the Federal Food, Drug and Cosmetic Act.  This, however, is not impossible.  Already, the Vioxx case has made Congress aware of problems within the drug industry.  During the hearings on Vioxx, Senator Chuck Grassley of Iowa remarked: "The health and safety of the public must be the FDA's first and only concern."[3]  Within the last five years a handful of bills have been introduced in the Congress involving DTCA.  Many of them have sought ways to diminish the role that DTC ads play in the prescription process.  One such bill titled "Say No to Drug Ads Act," introduced by Representative Jerrold Nadler of New York, proposed amending the Internal Revenue Code to limit deductions for advertising.[4]  Oftentimes, it can take years for Congress to acknowledge a problem.  It appears, however, that when it comes to prescription drugs, it is already aware.

Solution Three: Create a more rigid and standard form for DTC television ads.

Information in DTC ads will provide more of a benefit to the consumer if they are more appropriately balanced.  Consumers must be aware of a drug's risks in order to be properly informed.  The FDA acknowledges this by requiring ads to be fair and balanced.  Most ads, however, do not seem to have a balanced presentation of risks and benefits.  One study done on physicians found that 94% believed that DTC ads in television lacked a balanced presentation.[5]  Forcing drug companies to literally give a balanced and equal presentation of risks and benefits within ads would help improve this.  After all, the purpose of DTCA is to sell products.  The natural tendency then is to emphasize the benefits of the drug.  This may help sell drugs, but it does not provide beneficial information for the consumer.  If the FDA were to require that 50% of an ad's time be dedicated to risks, it may result in more beneficial information.

Another benefit to this solution is that it appears to be rather easy to implement.  The FDA would simply have to "re-reinterpret" the guidelines and make a 50% requirement mandatory in the fair and balanced criteria.

The problem in this solution, however, is that even if the regulations are changed to increase the amount of risk information, there is still no guarantee that consumers will benefit from the information.  It is possible within this solution that consumers will not understand the risks.  A solution to the problem must do more than provide additional risks; it must guarantee that the whole ad, risks benefits, are providing beneficial information to the consumer that they understand and benefiting the patient-physician relationship.  This solution does not guarantee that.

Solution Four: Change federal law to disallow DTCA.

It is possible that DTCA is too complicated an issue to guarantee its utility to the public.  Banning all forms of DTCA of prescription drugs would stop the flow of information, and therefore guarantee that the consumer would not be harmed.  Many problems and costs, however, coincide with this solution.  First, banning all forms of DTCA would not permit  any information about prescription drugs to be provided to the consumer.  It is hard to argue that a complete lack of information provides a benefit.  There surely is some balance, and method to present information in a beneficial way.

Secondly, the banning of all forms of DTCA may not be possible.  Any type of law banning such advertising would not fare well in the courts.  DTCA is here to stay in one form or another. Next