Healthy Skepticism Library item: 6784

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

Center for Drug Evaluation and Research
CDER 1997: report to the nation
: U.S. Department of Health and Human Services 1998

Abstract:

In fiscal year 1997, CDER issued 532 advisory letters to companies regarding their promotional materials for launch campaigns. CDER issued 183 regulatory action letters to pharmaceutical companies for prescription drug promotions determined to be false, misleading or lacking in fair balance. There were 240 letters issued in all categories regarding DTCA. The Center continued its research, education and outreach activities in support of providing consumers with easy to read information about their prescription drugs. CDER proposed standardization of over-the-counter drug label formats. Finally, CDER is conducting research to assess the public’s ability to understand risk versus benefit information.

Keywords:
*analysis/United States/Centre for Drug Evaluation and Research/safety & risk information/regulation of promotion/labeling/EDUCATING ABOUT PROMOTION: CONSUMERS AND PATIENTS/EVALUATION OF PROMOTION: JOURNAL ADVERTISEMENTS/REGULATION, CODES, GUIDELINES: COMPLIANCE, SANCTIONS, STANDARDS/REGULATION, CODES, GUIDELINES: DIRECT GOVERNMENT REGULATION