Blog #1: Industry-supported Scietific and Educational Activities

Theresa Seiverd
BW706-Blog 1
1. Name: Industry-supported Scientific and Educational Activities
2. Status: Final Guidance
3. Release Date: December 3, 1997
4. Link to Guidance: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125602.pdf
5. Target Audience: Health care professionals, companies (ie, sponsor of the marketed product), providers, provider (ie, individual or consultant that facilitates the educational activities)
6. Laws and regulations referenced: There are no regulations referenced in this guidance. The FDA (ie, the agency) has not had oversight into company activities that support scientific seminars and educational forums and does not intend to regulate these activities which are considered independent of the supporting sponsor.
7. Summary:
The goal of the guidance is to ensure that industry-supported scientific and educational activities are designed to be nonpromotional and independent of any outside influence from individuals by evaluating programs and presenters by the following factors:
o Control of content and selection of presenters and moderators: The agency will take into consideration whether the sponsor maintained control over the content of the program and selection of speakers.
o Disclosures: The agency will take into consideration the company’s funding and the relationship between the presenters and the sponsor. The agency will also consider if any unapproved uses of the product are planned to be discussed.
o Focus of the program: the agency will take into consideration the content of the program is independent of any commercial influence and ensure the content is provided in the context of relevant and reasonable options or alternative therapies.
o Relationship between the provider and supporting company: The agency will take into consideration the relationship between the company and the provider to ensure the company has no influence over the content being presented.
o Provider involvement in sales or marketing: The agency will consider if the provider that is involved in conducting the scientific or educational activities is not involved in any sales or marketing of the company’s product.
o Provider’s demonstrated failure to meet standards: The agency will take into consideration the provider’s history in conducting educational programs and whether they met the expectation of conducting an independent educational program free of any promotional bias or external influence.
o Multiple presentations: The agency will consider if multiple presentations are being held with the understanding that sometimes multiple presentations are necessary and in the public’s best interest.
o Audience selection: The agency will take into consideration if the sales and marketing departments of the sponsor company were involved in generating the mailing list and invitations for the educational or scientific-supported event.
o Opportunities for discussion: The agency will take into consideration the discussion or questioning period of the program.
o Dissemination: The agency will take into consideration if the information is further communicated after the initial program through an independent provider.
o Ancillary promotional activities: The agency will take into consideration any promotional activities (ie, sales presentations or exhibits) taking place in addition to the education program.
o Complaints: The agency will take into consideration any complaints from the program’s participants, the provider, or presenters with regard to the sponsor influencing the content presented.
8. Rationale:
This guidance seeks to protect the sponsors, providers, health care professionals, and ultimately the patients to ensure educational and promotional activities of a product’s benefits are not potentially jeopardized from false or misleading information be communicated. Information must be presented independently of any bias being introduced by the sponsor such as unapproved uses for the product that are not indicated on the label, and discussions of the product’s use that are misleading or not scientifically proven. This same expectation is applied to a company’s competing products too. Information being communicated must be scientifically supported and indicated in the product label.
9. Resulting recommendation: The agency does not mandate, but recommends there is a written agreement between the company sponsor and provider. The agreement should be reflective of the responsibility of the provider to design and conduct an educational activity that is free from any company or commercial influence.
10. Impact: This guidance offers companies and educational providers a basis for how to conduct educational activities in a manner that is responsible, accurate, and professional for both sides. The considerations put forth by the agency are appropriate and adequate to ensure industry supported scientific and educational programs are communicating information to health care professionals that have the patient’s best interest up front.