Healthy Skepticism Library item: 6604

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: report

Wolfe SM
Testimony: FDA hearing on direct-to-consumer advertising of prescription drugs
1995 Oct 19
www.citizen.org/hrg/

Abstract:

The primary purpose of advertising, either to physicians or to consumers, is to sell drugs and the history of both kinds of advertising demonstrates that such ads are designed to be as misleading and, sometimes, false as thy can get away with. In the area of physician drug advertising, the study by Wilkes and colleagues three years ago (Michael S. Wilkes, Annals of Internal Medicine 1992;116:912-919) demonstrated that a substantial proportion of clearly regulated physician ads-not previously cleared by FDA and going to an audience more knowledgeable than patients-were false or misleading. There is little question that, as exemplified in the tragic case of direct-to-consumer promotion of Lilly’s arthritis drug, Oraflex, patients, armed with misleading information, can greatly influence their physicians’ decision to prescribe a drug. The recent ad from Medical Marketing and Media, shows how eager the media are to convince drug companies that by taking out direct-to-consumer ads in their publications, they can reach, and influence, not only patients but also their physicians. The ad for Virazole, not “voluntarily” sent to the FDA for pre-approval, demonstrates how dangerous it can be to rely on a voluntary approach to regulating such ads. We favour a moratorium on DTC prescription drug advertising until FDA has in place a set of regulations aimed specifically at such ads, rather than using regulations intended to cover physician and other health professional advertising. In the alternative, while such regulations are being promulgated and finalized, FDA should be much more aggressive in insisting on prior clearnace of all such ads and taking appropriate enforcement actions whenever serious violations occur.

Keywords:
*analysis/United States/direct-to-consumer advertising/DTCA/Eli Lilly/quality of information/quality of prescribing/ consumer behaviour & knowledge/ FDA/ Food and Drug Administration/ Opren and Oraflex/regulation of promotion/EVALUATION OF PROMOTION: DIRECT-TO-CONSUMER ADVERTISING/INFLUENCE OF PROMOTION: CONSUMERS AND PATIENTS/INFLUENCE OF PROMOTION: PRESCRIBING, DRUG USE/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION