Few clues on FDA exhibit rules

Imaging equipment and pharmaceutical manufacturers are waitingwith bated breath for the unveiling of revised Food and Drug Administrationguidelines on industry participation in medical meetings. Withoutmajor revisions, the FDA proposal would restrict equipment exhibitsand industry sponsorship of medical meetings (SCAN 5/20/92).

The FDA has been in the rewrite stages since March after receivingmore than 200 comments on the proposal, according to Mike Shafer,an FDA press liaison.

The guidelines were prompted by concerns about abuses in industry-fundedcontinuing medical education programs. The FDA, which regulatespromotion of medical devices, devised the guidelines to definephysician education versus product promotion.

Initially aimed at pharmaceutical companies, the revised guidelinesare expected to target imaging equipment manufacturers as well,according to Robin Wiley, assistant for legislative affairs atthe National Electrical Manufacturers Association.

The policy would permit industry sponsors to continue to fundCME programs, specialty society meetings, medical journals, videotapesand computer software. But companies must not suggest speakersor topics, or influence content in any way. Nor would they beallowed to distribute materials about products that detail unapproveduses.

A component of the proposal would also restrict exhibits ofunapproved devices at medical meetings. A new FDA branch has alreadybeen established to monitor compliance, according to Wiley. Firmdetails about the new policy remain elusive, however.

"There have been a lot of rumors floating around but wehave yet to see new guidelines coming from the FDA," shesaid. "We do know they are working on ways to include devicemanufacturers in the guidelines."