Table 2.

Factors Used by the FDA to Determine Independence

Control of content: Has there been scripting or other actions by the supporting company designed to influence content?

Disclosure: Has funding for the program and any legal or business relationships between the company, providers, and presenters been disclosed, particularly for an off-label discussion?

Program focus: Is the educational discussion fair and balanced? Does the title accurately represent the presentation?

Provider’s sales or marketing activities: Are provider employees also producing marketing or promotional programs?

Provider’s demonstrated failure to meet standards: Does the provider have a history of biased programs?

Multiple presentations: Do repeated presentations serve the public health interest?

Audience selection: Is the audience generated by a sales or marketing department in order to achieve marketing goals?

Opportunities for discussion: Is an opportunity for meaningful discussion provided?

Dissemination: Does the supporting company distribute additional information after the activity (unless requested by the participant and then provided through an independent provider)?

Ancillary promotional activities: Are promotional activities occurring in the same room as the educational presentation?

Complaints: Have there been complaints about the sponsoring company by providers, faculty, or others?

Modified from From Malone P, et al. (eds). Drug Information: A Guide for Pharmacists, 3rd ed, 2006. With permission from The McGraw-Hill Companies.⁶