CME Notes The Food and Drug Administration (FDA) has released its final guidance letter for industry-supported scientific and educational activities. It is a far cry from the original 1992 draft letter. Important differences (direct quotes from the guidance are presented in quotation marks):
*Pharmaceutical firms may suggest speakers for CME activities--as long as those speakers aren't, and haven't been, actively involved in promoting the company's products, and have not been the subject of complaints or objections for giving misleading or biased presentations in the past.
*When presenting different treatment options, speakers are not required to give each product precisely equal emphasis. "Emphasis on a newer or, in the view of the presenter, more beneficial treatment modality should be provided in the context of a discussion of all reasonable and relevant options."
*The language about not having promotional activities in an obligate path to the education sessions is gone. Promotional activities going on in the same room as the education are not allowed.
*The FDA does not require, but strongly recommends, a written agreement between industry supporter and CME provider.
*The FDA has made plain that no single violation of its guidelines will make a program subject to regulation. "These factors will be considered as part of an overall evaluation. . . No individual factor is likely by itself to stimulate an action based on lack of independence."
Copies of the guidance are available at www.fda.gov/cder/guidance/isse.htm.
The price of success: Attendees at this year's Alliance for CME conference, held at the Hotel del Coronado, in Coronado, Calif., spent a little more time than usual gazing at the ocean, the gardens, and the other amenities at the property, because they knew they were seeing it for the last time, at least while attending this meeting. "We'll never be able to meet in a place like this again," sighed one Alliance board member. "We've outgrown it." Next year's conference will be at the Atlanta Hilton and Towers, which will be more than filled if the '99 meeting draws the same record-breaking crowd of 1,500.
Team teaching? Or Family Feud? Just as CME providers are starting to demonstrate that physicians will attend meetings with nonphysicians, a feud is erupting between physicians and nurses. In Illinois and Michigan, the state medical societies are lobbying to quash laws that would allow nurses to diagnose disease and prescribe drugs without a physician's supervision. Nursing organizations are lobbying on the opposite side. If you're planning a meeting involving both, success could hinge on a good understanding of any local turf wars over prescribing authority. *