From: ALTARNEST@aol.com Sent: Saturday, November 22, 2003 10:29 PM To: fdadockets@oc.fda.gov Subject: Direct to Consumer Advertising #03n-0344 Posted to FDA Docket # 03n-0344 November 22, 2003 As health care professionals, we believe that the direct-to-consumer prescription drug advertising (DTCA) currently offered in our mainstream media can be balanced with objective and sound health-promoting information that includes the consumers as a partners in their own health decision making process. After much research into the issues surrounding DTCA, we submit to you a workable alternative that will address present concerns: DTCA Interpretive Guides 1) In the form of pamphlets, messages on TV and radio, and in websites 2) Created to target various consumer educational levels, learning styles, culture and language differences 3) Content: a) explanation that the purpose of advertisements is to bring about pharmaceutical company profits b) explanation that there are both beneficial and substandard advertisements c) definition of terms commonly used in ads, such as “adverse reaction,contraindication, Gl, GU, CNS, generic, pregnancy categories”, etc. 4) Tips on how the consumer can effectively approach their health care providers the DTCA information learned 5) Life style and behavioral changes that can improve conditions treated by the advertised drugs. 6) Instructions that the consumer seek further treatment information from their health care providers. We see an equitable resource for funding these DTCA Interpretive Guides: Tax Incentives for Pharmaceutical Companies Contributions could be made to an educational fund with revenues received from tax credits given to pharmaceutical companies, based on a certain percentage of their advertising costs. The result will be that companies who spend more on advertising will contribute proportionally to this fund. This design will not penalize the pharmaceutical industry, whose profitability, we do understand, leads to new life saving treatments. The educational fund could be utilized by agencies currently collaborating in the dissemination of public health information, such as the CDC, NIH, or the FDA’s Office of Training and Communication We look forward to hearing your response to our posting. Thank you. Kristin Altar RN BSN, Susan Clark RN BSN, Yonette Exeter RN BSN, and Janelle Stank RN BSN University of Maryland, School of Nursing Graduate Students Participating in NURS6O6 ~Systems in Health Care Delivery— Fall 2003