Prepared by the Coalition for Healthcare Communication

Background

In 1991, FDA issued for comment, a draft set of guidelines to define a "safe harbor" in which companies could support educational activities sponsored by industry for healthcare professionals, which might include off-label information, if it was independently prepared and presented. The initial draft guidance was widely criticized and a second "draft" version was issued in 1992. While more acceptable to some, others felt that government should not be involve in regulating scientific exchange of information.

Among them was the Washington Legal Foundation (WLF), which initiated a citizen’s petition and later sued the agency on First Amendment grounds when it did not respond to the petition. It marks the first time since the early 60's that the FDA has been sued over its regulation of communication issues.

The ensuing court decisions are complicated. The U.S. District Court in Washington permanently enjoined FDA from applying two documents governing so called "off label" new uses for approved drugs and industry-supported CME. The court enjoined FDA from in any way limiting any pharmaceutical or medical device manufacturer from disseminating specified journal articles or medical texts and from "suggesting content or speakers" to an "independent program provider" in connection with a seminar or symposium funded by the manufacturer. FDA appealed.

The U.S. Court of Appeals ruling is confusing in that they threw out the FDA appeal but also did not seem to support the lower court's injunction against FDA's CME guidance. FDA claimed the injunction was lifted while WLF claimed that the injunction was in force and FDA was flouting the decision. WLF brought the issue to court and the matter awaits another decision.

In reality, however, the FDA has achieved its goal in that almost all continuing education companies and providers have adopted the guidance issued in 1993, since the agency has informally assured them that programs conducted under the guidance would be acceptable. On December 3, 1997, the FDA updated the guidance in the Federal Register. This document will serve to simplify and spell out the provisions of the 18 page Federal Register Notice.

Overview
The agency acknowledged that the responsibility of overseeing the process of postgraduate and continuing medical education (CME) activities and scientific exchange lies with the scientific and healthcare communities and the accrediting organizations. The agency adds that no single factor (in the guidance) will trigger FDA action but it will look at all factors in determining if the CME program was independent.

Factors in Determining Independence

• Control of content or selection of presenters or moderators
  The provider should have sole control over this process. While speakers can be suggested by the sponsor, final determination rests with the provider. Any company participation in the process of preparing the content or selecting the speakers could be scrutinized by the agency and considered independence.
  
• Disclosure
  Presenters should disclose company funding of the program and any relationship they have with the company. If the talk contains off-label information, it should be noted.
  
• Focus of the program
  A focus on a single drug should be avoided except in cases where it is the only reasonable treatment available. The title of the program should accurately represent the content and the presentation should include discussion of reasonable therapeutic options.
  
• Relationship between provider and supporting company
  The agency will be especially vigilant if the provider is tied in any way to the company or if the provider would not be viable without the support of the company. The assumption is that the company would exert influence over a dependent provider.
  
• Provider involvement in sales and marketing
  Independence would also be in question in situations where the provider is also involved in consultation or marketing of the drug.
  
• Standard provider
  Companies should steer clear of providers with a track record of producing programs that fail to meet standards of balance, objectivity, independence and scientific rigor.
  
• Multiple presentations
  The issue of multiple presentation is still in the guidance language despite earlier criticisms and the fact that HHS sometimes encourages multiple presentations. The agency remains suspicious of "road shows" that may have an unacceptable agenda (our words, not theirs).
  
• Audience selection
  Invitations to the program should not be limited to persons selected by the company that might favorably effect the sales or marketing goals of the company, such as high prescribers or opinion leaders.
  
• Opportunities for discussion
  Simply put, there should be provisions for discussion lest the agency deem that the opportunity to provide balance was stifled.
  
• Dissemination of information
  Any further dissemination of information following the program would be subject to scrutiny except that done by the independent provider or in response to an unsolicited request.
  
• Ancillary activities
  There should be no sales activity in the meeting room of the CME activity.
  
• Complaints
  Complaints on the part of the provider, presenters, or attendees regarding company attempts to influence content would be carefully considered by the agency.
  

The Written Agreement
While the agency has placed less emphasis on the written agreement between the provider and the company, they, nonetheless, continue to believe that an agreement is needed to document steps the parties intend to take in order to preserve independence. The guidance did not propose any format for the written agreement as it had in the draft.

Copies of the complete guidance are available from the Coalition office.