The National Consumers League Direct-To-Consumer Promotion of Prescription Drugs Roundtable II Consensus Report

Introduction

The recommendations and conclusions below represent a consensus of opinions of the participants of the National Consumers League Direct-To-Consumer Promotion of Prescription Drugs Roundtable, held on September 28-29, 1998.

Prescription drugs are powerful products with tremendous healing potential that often have serious risks and side effects, and are only available through a health care professional. What product-specific, direct-to-consumer promotion of prescription drugs (DTCP) should encompass and how it should be regulated is an important concern. DTCP is beginning to have a significant influence on the public and may influence drug selection and use decisions by health care professionals and consumers.

DTCP of Prescription Drugs: Information for Consumers

• DTCP is an effective vehicle that motivates consumers to seek information, especially from health care professionals. More needs to be known about health consequences of this form of promotion as well as its affect on the patient-health professional relationship.
  
• Promotion and advertising can only convey a limited amount of information about medications due to time and space constraints. Additional information sources offering a balanced appraisal of the medication's safety and effectiveness must be available for consumers.
  
• Any DTCP campaign may be limited for some audiences, e.g., elderly, less literate, and non-English speakers, and should consider the impact on those populations.
  
• Health care professionals should receive different messages than consumers regarding medications. While health care professionals should receive more technical information, consumers need easy-to-understand, consumer-friendly, useful information about the benefits and risks of the medicine. Consumers also need usable information about their condition and medication when they receive their prescription medicines.

Current Brief Summary

• For print ads, there was agreement that the brief summary, presented in its entirety, frequently written in small type and technical language, does not communicate useful information to consumers.
  
• Information needs to be less detailed and more consumer friendly.
  
• For those consumers who desire more information, it should be made available through alternative sources such as web sites, 800 phone numbers, and pamphlets at physician offices, clinics and pharmacies. When an 800 number is a source of information, the provider should give unbiased and accurate information and should not use the contact for promotional purposes. There should be full disclosure to consumers of any information captured through a web site or 800 number, with an opportunity for the consumer to opt out of the program or not be subjected to follow-up phone calls or mailings.
  
• The FDA should, separate and apart from its Draft Broadcast Guidance, clarify in a Federal Register notice that its drug advertising regulations will not be interpreted to require dissemination of the complete brief summary as part of a print promotion for a pharmaceutical product. However, useful, consumer-friendly information must be disseminated in conjunction with any and all print or broadcast ad campaigns.

Alternatives to the Brief Summary

• For print ads, the current brief summary format used by most advertisers should be replaced with a more consumer-friendly presentation of information. Alternatives include:
  
  • For print ads, the current brief summary format used by most advertisers should be replaced with a modified format with a more consumer-friendly presentation of information. Some of the group suggested eliminating the brief summary requirement, and in its place, incorporating the pertinent information in to the body of the ad itself, similar to broadcast ads. The majority felt this would be insufficient. Others thought print ads should remain separate and distinct from broadcast ads with a more consumer-friendly brief summary as a vital component.
    
  • For print ads, the brief summary should be re-formatted to better reflect its purpose, to provide a summary of the most important usage and safety information in consumer-friendly language. The brief summary format should reflect the recommendations of the 1996 Keystone Committee, which were approved by HHS Secretary Shalala that includes the most serious and most frequent side effects. This uniformly-structured format should provide information about the disease the drug is intended to treat, and what the drug does and does not do. The ads should have a basic framework regarding how the important and necessary information is conveyed, with flexibility for advertisers to design the ads. A useful format is the "question and answer" format with information presented in a consistent, logical order.

Standard Information Messages

• A series of generalized standard messages is desirable, including general information about efficacy, compliance, risk, contraindications, and interactions between drugs and food and drugs.
  
• Messages should rotate frequently to avoid "wear out." They could also be integrated completely in the ad.
  
• A possible approach is to provide very specific parameters for standard information messages and allow manufacturers to design their own. These messages should convey the concept of who should and should not take these medications to avoid unnecessary physician visits or increased expectations about benefits of the medications. But, the physician should make the ultimate decision.
  
• Some participants, but not a majority, believed these generalized statements could replace the brief summary entirely for certain, limited classes of drugs. This was particularly true for "help-seeking ads," which include little or no promotion of particular drug products. Other participants stated these general statements should be included in addition to an abbreviated "brief summary" or whatever risk disclosure replaces it. Another suggestion was that risk information be "set off" in a box.

Broadcast Advertisements

• Some participants concluded that the same standards should apply to print and broadcast media ads. Other participants concluded that requirements for print and broadcast ads should be functionally equivalent, but not necessarily the same.
  
• For broadcast ads, consumers should receive useful, comprehensive information.
  
• Alternatives to providing the drug's full approved labeling are probably useful to most consumers and should be sought. Sponsors should make "adequate provision" for the dissemination of nonpromotional, consumer-friendly information, and it was suggested that it could be the information required in a new brief summary. The full package insert should be made available to any consumers upon request, however, that briefer, more consumer-friendly formats would be acceptable.
  
• Some participants concluded that some broadcast advertising provides an inadequate major statement of a drug's risks and side effects, and that the ads as they are now are too promotional and often oversell the benefits while downplaying risks and side effects. For example, visual images are often at odds with the audio text. All images (both audio and visual) should be complementary. Some participants believed the audio and visual risk information should be presented concurrently, e.g., with scrolled text that parallels the voice-overs.
  
• Other participants concluded that the mechanisms for "adequate provision" need to be more user friendly, and not, for example, difficult-to-understand messages from a toll-free number.

Fair Balance

• Participants favored retaining the "fair balance" requirement.
  
• Some participants called for FDA to make its fair balance decisions and its basis for such decisions more transparent.
  
• Some participants stated that proper context was important and that the overall impression of an ad should not conflict with the approved indications. For example, visual images should not portray activities or illnesses for which the medication is not approved to treat.
  
• Some participants believed that where risks appeared with approximately the same frequency as with a placebo, specific identification of this type of risk information might be unnecessary. In lieu thereof, there should be a general statement such as "There are risks associated with taking all prescription drugs. Speak to your doctor or pharmacist about the risks associated with ...."
  
• DTCP cannot provide consumers with sufficient background information to fully understand the spectrum of risks, safety, and potential effectiveness of drugs.

Recommendations for Consumer Education and Research

• Industry and health care professionals should consider supporting broad public service campaigns to provide consumers with basic information so they can better understand DTCP claims.
  
• There is a need for better and more information regarding disease conditions and the appropriate role of medications.

Research into DTCP is necessary and important in the following areas:

• The extent to which consumers comprehend important health information conveyed in a variety of formats, such as the current brief summary, full package labeling, approved patient labeling, major statements of risks in broadcast advertising, and modified MedGuide.
  
• Whether DTCP improves or lessens public health.
  
• The effect of DTCP on compliance with prescribed medication.
  
• What effect DTCP has on the physician-patient relationship.
  
• Results of such research should be made available through publication in the professional and lay press.
  
• Pharmaceutical manufacturers should provide educational programs for health care professionals prior to or concurrent with promotions in order to complement DTCP ad campaigns to consumers, so that communication about appropriate use of pharmaceuticals between health care professionals and consumers is effective.

Resources for Enforcement

• FDA is working to enforce DTCP requirements and should be adequately funded to monitor ads and continue to protect the public health. FDA is under-funded and cannot fully enforce its regulations because of increased workload responsibilities and inadequate resources.
  
• Agencies such as AHCPR should be funded to study the health consequences and outcomes from DTC ads.