Originally Published MDDI January 2005
Despite federal court rulings that decreed FDA went too far in restricting promotion of medical products, the agency hasn't changed its policies on advertising and promotion. Therefore, panelists at a session of the RAPS annual meeting in October said device companies need to treat this issue with caution, especially at the clinical stage.
FDA officials present at the discussion said that it is not appropriate for a device company to conduct advertising or promotion of a premarket approval product that is not cleared for marketing.
Therefore, before approval, public pronouncements about a device's efficacy should be left only to the clinical investigators, as FDA does not regulate discussion of research.
"Publicizing live cases is a good way to disseminate valid scientific information, but the sponsor must remain distant," said panelist Michael Morton, senior director of regulatory affairs for CarboMedics Inc. (Austin, TX), a Sorin Group company. "But the investigator must present science. You want to protect your investigator's reputation."
If a hospital organizes press coverage of an investigational device, that is fine, Morton said. But the device manufacturer must not coach anyone involved or conduct any advertising as part of the effort. The firm should, however, ensure that the device's commercial unavailability is mentioned, along with a disclaimer that the device is being studied for safety and effectiveness.
Displaying an investigational device at a trade show is acceptable as long as the firm mentions that the product is not available in the United States, and that "there are no claims, no preselling, and no prequalification of accounts," Morton said.
A gray area, however, is that while regulations don't allow promoting or test-marketing an investigational device until after FDA approval, "the regulations have no definition of 'promote'," said Robert Klepinski, president of Klepinski & Duval PA (Minneapolis). "And 'you can't say anything' would be unconstitutional," given the court decisions of the past few years.
Device companies, then, may be best served by heeding Morton's advice: "Use your judgment. Make sure what you do makes sense."
Copyright ©2005 Medical Device & Diagnostic Industry