Potential Solutions

 
Intro
Putting it in Perspective
DTCA History
DTCA Evolves
DTCA Today
Potential Solutions
Cost/Benefit
Recommendation
End Notes
Bibliography

 

A solution to the problems created by DTCA must guarantee that the public is properly protected from prescription drugs, and make certain that the limited amount of information presented in the advertisements results in a benefit to consumers, and does not interfere with the patient-physician relationship.  DTCA currently leads to an excessive amount of confusion between patients and physicians.[1] A solution must reasonably guarantee that DTC ads benefit consumers by providing them with helpful, easy to understand, and comprehensive information.  If consumers are given a more balanced presentation within DTC ads, then their conversations with their physicians will be more informed and beneficial.  Listed below are four potential solutions.

Solution One: Keep the status quo including the requirements of the 1997 "Draft Guidance for Industry and FDA."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 from previous standards, and therefore should not be altered.  Before 1997 reminder ads on television were used much more frequently because the regulations were not conducive to more informative product claim ads.  Reminder ads were extremely vague, stating a drug's name with no additional information. These advertisements did in fact create confusion between physicians and patients.  For example, a president of a major drug company remembers a gynecologist calling him reporting that his patient had asked if she was a candidate for Claritin, an allergy medication.  The patient had no idea what Claritin was for, because reminder ads cannot give that information. She was hopeful that it could solve her non-allergy related problem.[2] Ads such as these provided consumers with little to no helpful information. 

The 1997 "Draft Guidance," however, permitted for product claim advertisements to be broadcast on television.  These ads were able to divulge much more information to consumers.  Proponents of the current DTCA guidelines claim that the pre-1997 standards led to confusion on the part of consumers, and that the current regulations have solved this problem and allowed for the dissemination of beneficial information.

Solution Two: Create a mandatory testing policy for DTCA.

The AMA and many public health groups, such as Public Citizen, have endorsed various sets of voluntary standards for DTCA of prescription drugs.  One such group is Ethicad.  Ethicad is a non-profit organization dedicated to improving DTCA of prescription drugs.  It is the organization's belief that DTCA of prescription drugs can be beneficial to consumers, physicians, and pharmaceutical companies if some adjustments are made.  It recommends a series of tests to guarantee the well being of the public.  Among these suggestions is the use of consumer and physician focus groups that can be used to determine how well a drug's benefits, uses, and side effects are being both retained and understood.[3]

The problems that DTCA of prescription drugs present can largely be solved if the FDA creates a system of mandatory testing based on these standards.  This could be done without increasing the size and responsibilities of the FDA.  The FDA's role could simply be to create a set of research and testing criteria that all prescription drug advertisements must pass.  The drug companies already direct large amounts of their advertising budgets to research, after all they have to be reasonably sure that the ads will result in an increase in sales.  This solution would just force more of their research to be done according to FDA standards.  Insuring that all advertisements adequately inform, rather than persuade, the public will help maximize the informational benefit of DTCA.

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

The problems with DTCA have evolved mainly from the dramatic increase in television ads, which account for 70% of the promotional money spent by the drug companies on advertising.[4]  All ads are required by law to present information about benefits and risks in a balanced manner.  The "Draft Guidance" of 1997 permitted advertisers to meet this standard by, “disclosing the most serious and the most common risks associated with the drug and giving out a toll-free number and or Internet site for consumer access."[5]  It did not, however, give any standard for time requirements or percentages.  In other words, if an ad can present the most serious and most common side effects in 10 seconds then it has met the requirement.  It certainly is true that the whole list of a drug’s side effects and precautions are unable to fit into a 30 second advertisement.  But requiring advertisers to spend at least as much time on risks as they do benefits would certainly come closer to the balanced presentation requirement in the law.  

In order to assure that consumers are being adequately informed of the costs and benefits of a drug, the FDA should require that 50% of an ad is dedicated to risks.  A study done by the GAO showed that the amount of risk information  in a television ad recalled by a consumer is directly related to the amount provided.  In other words, the more risk information presented results in more retained information by the consumer.[6]  If the information within a DTCA is to have an overall benefit for the consumer, then the FDA must change its guidelines to help increase the amount of risk information obtained by the consumer.

Solution Four: Change federal law to disallow DTCA.

The overall effect of DTCA may be harmful to the public.  Rather than educating the public, DTC ads too often persuade the public into asking for prescription drugs that they may not have otherwise have requested or been given.  Prescription drugs have very serious risks associated with them.  The expertise of a physician is needed in order to evaluate these risks for each individual patient.  DTC advertisements are designed to sell products with a series of complicated and technical guidelines, and they are used to persuade non-professional consumers who have little knowledge within the medical field.  Appealing to individual emotions to sell products as technical and complicated as prescription drugs is dangerous and poses a serious threat to the well-being of consumers and the prescription drug process.  For this reason, direct to consumer advertising of prescription drugs should be made illegal by an act of Congress. Next


   

 

 

Jackson Ryan Fisher| jfisher5@naz.edu

Nazareth College Undergrad

History/Political Science Department | Nazareth College