Healthy Skepticism Library item: 6536

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

Pendergast MK
Statement before the Subcommittee on Regulation, Business Opportunities, and Technology Committee on Small Business, U.S. House of Representatives
Rockville, Maryland: Food and Drug Administration 1994 Oct 12

Abstract:

This statement briefly describes the current environment the Food and Drug Adminstration confronts in its efforts to regulate the pharmaceutical industry’s promotional activities. At present, this industry spends upwards of $10 billion annualy on promotional activities. The author goes onto to describe the agencies existing authority and its key activities related to enforcing the drug promotion requirements. Finally, she discusses some of the types of promotional activities they are now encountering and the challenges such activities present to their efforts to protect consumers from false, misleading and unfair prescription drug promotion.

Keywords:
*analysis/United States/Food and Drug Administration/FDA/regulation of promotion/DTCA/direct-to-consumer advertising/labeling/enforcement pyramid/unlabeled indication/corporate funding/continuing medical education/CME/ ghost writing/ pharmacoeconomic analysis/ drug company sponsored research/ATTITUDES REGARDING PROMOTION: REGULATORS AND GOVERNMENT/EVALUATION OF PROMOTION: DIRECT-TO-CONSUMER ADVERTISING/EVALUATION OF PROMOTION: INFLUENCE TECHNIQUES/PROMOTION DISGUISED: CLINICAL TRIALS/PROMOTION DISGUISED: GHOST-WRITING AND JOURNAL ARTICLES/PROMOTION DISGUISED: PHYSICIAN EDUCATION MATERIAL AND GUIDELINES/PROMOTION DISGUISED: POSTMARKETING RESEARCH/PROMOTION DISGUISED: PRESS CONFERENCES AND PRESS COVERAGE/PROMOTION DISGUISED: SUPPORT FOR CME/PROMOTIONAL TECHNIQUES: UNLABELED INDICATIONS/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION