On November 1-2, 2005, the Food and Drug Administration (FDA) hosted a 2-day public hearing to provide an opportunity for broad public participation and comment on direct-to-consumer (DTC) promotion of regulated medical products, including prescription drugs for humans and animals, vaccines, blood products, and medical devices.
FDA was particularly interested in hearing the views of individuals and groups most affected by DTC promotion, including consumers, patients, caretakers, health professionals (physicians, physicians' assistants, dentists, nurses, pharmacists, veterinarians, and veterinarian technicians), managed care organizations, and insurers, as well as the regulated industry. FDA sought input on a number of specific questions, but heard other pertinent information from participants in the hearing.
This article summarizes the main points, both pro and con, made by presenters at this meeting and includes commentary from expert members of the Pharms Marketing Roundtable, which met to discuss the issues raised at this hearing.
Topics covered include:
- Pfizer Research into Risk Communication in DTC
- Five Key Learnings of the Research
- Role of DTC in Motivating Consumers to Seek Medical Help
- Pfizer's Recommendations to FDA
- How Much Risk Information is Enough?
- Disease Awareness Ads
- Use of Celebrities
- Pre-Approval of DTCA by FDA
- AstraZeneca's Risky Proposition
- Power of Images