Notes
121 C.F.R. § 202; FDA, Guidance for Industry: Consumer-directed Broadcast Advertisements. (Washington, DC: FDA, August 1997).
2Formerly known as Division of Drug Advertising and Labeling before 1991.
3The 10 studies are about format and content in brief summary, effectiveness of print ads, information processing in television ads, addition and wording of toll-free statement in television ads, risk and benefits information in television and print ads, patient and physician relationship, physician prescribing behaviors, gender differences in drug label information processing, and reactions to common terminology in ads.
4The Government Accountability Office, the audit, evaluation and investigative arm of Congress, examines the use of public funds; evaluates federal programs and policies; and provides analyses, recommendations, assistance to help Congress make informed oversight, policy, and funding decisions. GAO's core values are accountability, integrity, and reliability (GAO Mission).
6ALEC is the nation's largest individual membership organization of Democratic and Republican state legislators.
7The FDA only requires reviews of promotional materials from drugs treating serious illnesses or based on animal studies when human testing is not available.
8For example, Bristol-Myers Squibb would not launch consumer ads for a new drug in the first year, allowing the company time to educate physicians. Pfizer would improve its ads to communicate risks and reinforce the doctor–patient relationship. It also promised to invest as much in a campaign addressing important public health issues as it typically spends on ads for a branded drug. GlaxoSmithKline seeks approvals for all drug promotions before release.