May 17, 2004

Re: Guidance for Industry, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements, DRAFT GUIDANCE, Docket no. 2004D-0042

Dear Drs Frank and Byrd,

ATAC is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS and broadening access to treatment.

With regards to the proposed guidance on disclosing risk information in direct-to-consumer (DTC) print advertisements, ATAC would like to thank DDMAC for its work on establishing clear principles and a new format for more effective communication of relevant risks and side effects of medications. We would like to address some considerations based on our experience with HIV/AIDS medications and treatments for related conditions, including hepatitis C:

Defining and identifying relevant risks and adverse reactions

We feel that the proposed guidance provides a useful framework for ensuring that the most important safety information about medications is better highlighted and communicated in DTC advertising. We feel strongly that important risk information be highlighted rather than simply buried in lengthy text sections, and welcome the proposed "risk information window" as an appropriate format. Where necessary the risk information window should, as suggested, refer readers to additional text in the body of the advertisement.

In addition, we wish to make the following observations:

• The proposal to list only the 3-5 most common nonserious adverse reactions is in most cases a reasonable guideline, but may be inadequate for some medications. For example, the pegylated interferons (Pegasys and Peg-Intron) used to treat hepatitis C have a wide range of potential adverse reactions experienced with high frequency among patients. For that reason, we urge you to consider an alternative which would base the number of adverse reactions listed on how many exceed a certain threshold of frequency in patients (e.g., those that occur in at least 5-10% of patients), rather than relying solely on an arbitrary cutoff of the 3-5 most common.

• In some cases a particular side effect may not occur frequently overall, but certain patient populations and subgroups (e.g., in those with more advanced forms of a disease or condition, other comorbid conditions, or particular demographic characteristics [sex, age, race/ethnicity]) may experience this side effect with a greater frequency. We feel that where there is a reasonable expectation that a particular mediation will be taken by a significant number of patients in a subgroup at higher risk of experiencing a meaningful side effect, that this information be included in DTC advertising. We also urge the FDA to consider, where appropriate, requiring that precautions include text that notifies consumers when a particular medication has not been adequately tested within particular patient populations that may pose unique or different concerns regarding safety, efficacy, and dosing.

• We recognize that new and important information on adverse events frequently emerges over time, after initial marketing approval, warranting labeling changes and in some cases other interventions (e.g., "Dear doctor" letters) to communicate newly identified risks. Where relevant, this information must be incorporated in DTC advertising in a timely manner. We request that this guidance include a proposed timeframe for the submission and approval of such changes, and that a suitable mechanism within the FDA be identified for ensuring that labeling changes automatically trigger a prompt review of whether and how DTC advertising should be adapted. In situations where serious new contraindications, warnings, and/or precautions have been identified, we ask that the FDA further consider requiring that such new information be flagged in advertising for a 3-6 month period (e.g., with bold or highlighted text that stands out from the rest of the advertisement) to signal new information important to consumers who may already be familiar with prior versions of the advertisement.

Communicating and measuring change

We are concerned that the implementation of the new guidance may lead to some confusion among consumers accustomed to current formats and practices. For example, we can envision situations where a reader sees advertisements for two medications targeting the same condition and within the same class of drugs (e.g., HIV protease inhibitors or statins). If one advertisement follows the proposed Highlights format, while the other advertisement relies on reprinting complete label information, the reader may reasonably but incorrectly assume that the first medication has fewer side effects.

Therefore we request that the FDA consider how to announce, if approved, the proposed guidance to health care consumers and professionals. We ask the FDA to consider requiring a brief statement notifying readers of the new format on advertisements using the proposed Highlights format appearing within a six-month period following adoption of the proposed guidance. We further request that the FDA consider how to develop and implement a broader educational campaign informing consumers and professionals about how to read, understand, and interpret information in DTC advertising. Such a campaign would be a vital component of broader health literacy initiatives. We welcome creative approaches to education, using a range of media, targeted to a range of audiences, and provided in a range of venues. We would also strongly encourage the development of educational campaigns linked to particular conditions (e.g., HIV/AIDS, hepatitis C, heart disease, asthma, diabetes, common cancers, etc.), and would welcome the involvement and participation of health education organizations, service providers, and patient groups in the development of such campaigns.

We also request that the FDA develop a plan to monitor and evaluate the impact of the new guidance, if approved, on patient knowledge and understanding and on communication between patients and health professionals and pharmacists. We would also encourage drug manufacturers and other groups to research these questions. We further urge the FDA and manufacturers to identify or develop and to validate appropriate measurements of reading comprehension to guide the design of DTC advertising.

Access to complete and easily comprehended safety information

We feel strongly that complete safety information, in a format and in language readily understood by non-medical professionals, should be available for all medications. We collectively have substantial experience as HIV/AIDS and hepatitis C treatment educators and advocates with the demands and challenges of individual counseling, group education, community forums, production of fact sheets and newsletters, and participation on guidelines panels and government and industry advisory boards. We commonly hear from people living with HIV/AIDS that "nobody told me about [side effect] when I started this drug." In our experience, the time, resources, and in many cases knowledge of health care professionals and pharmacists advising people with HIV/AIDS on medications is far often too limited to adequately discuss all possible side effects of complex treatment regimens.

While this issue goes beyond the content of the proposed guidance, we do wish to take this opportunity to assert that patients and consumers need access to complete safety information, including infrequent adverse events or those unlikely to be drug-related. We do not feel that DTC advertising is necessarily the best or only vehicle for communicating comprehensive safety information, nor do we believe that professional labeling information-frequently the only source for complete safety information-is adequate or appropriate for non-professional audiences. We view Medication Guides and Patient Information materials as ideally suited to convey complete information. We encourage FDA to consider strategies for promoting the development of such materials, and to view issues regarding DTC advertising within the context of the overall information needs and resources available to consumers.

In that regard, we must insist that complete safety information be available to all consumers, and that DTC advertising provide not only a website but also a phone number for more information.

In conclusion, we support the proposed guidance, but wish the FDA to consider the concerns and requests that we have outlined. We recognize the limitations on the FDA's statutory authority, and welcome future dialogue about strategies to increase the impact and utility of this and other guidance documents. We continue to explore other advocacy options, including legislative and regulatory means, to improve consumer awareness, knowledge, and understanding of medication risk.

Sincerely,

AIDS Treatment Activists Coalition