Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FDA should ban "speaker lists" provided by drug companies to continuing medical education providers rather than eliminate drug company participation altogether in arranging CME programs, Mountain Area Health Education Center CME Director Daniel Dolan, MD, told the agency in comments on FDA's draft concept paper on company-sponsored scientific exchange. By banning speaker lists, Dolan said, FDA would "leave the drug companies free to assist in program production, pay speaker expenses and honoraria, and leave the topic selection and speaker entirely up to the recipient group." This "would remove an immense amount of useless money transferring through a central organization (which would often result in the same speakers speaking on the same topics anyway)," he maintained. The amount of money spent on arranging CMEs is a crucial issue, Dolan indicated. "Smaller medical societies," such as those included in Mountain AHEC, "do not have any administrative staffs" to comply with the proposed FDA guideline's proscription on company participation in setting up CME programs, Dolan stated. Mountain AHEC, an organization designed to bring CME programs to rural areas in western North Carolina, does not have the staff "to bank and dispense the money" provided by sponsoring firms as the guidelines would require, he said. Rural CME groups also rely on sponsors for "arranging flight schedules, meeting and transporting speakers, and arranging meeting and overnight accommodations where necessary." The proposed guidelines already have affected the AHEC program directed by Dolan: "One drug company has already threatened to withdraw completely, put on its own CME programs, [and] call them promotional (with all the trimmings)," he said. Mountain AHEC "has produced a CME network where there was none," Dolan added. "I doubt [the network] can withstand your guidelines" because the "decentralized medical societies" in the AHEC use "more drug-funded speakers than we do locally" at the University of North Carolina-Chapel Hill, where Dolan is a faculty member. At least 104 of 411 CME programs provided by the AHEC were funded by drug companies, Dolan noted. "One group queried indicated they would simply cease activities," he said. Dolan's comments appear to voice a common feeling among the 33 university and hospital CME organizations that commented on FDA's draft guidelines, i.e., that the proposal will have a disproportionate impact on rural CME organizations. Among small hospitals writing to oppose FDA's proposal were Saint Joseph's Medical Center in South Bend, Ind., Hackley Hospital in Muskegon, Mich. and Robinson Memorial Hospital in Ravenna, Ohio. Robinson CME Director Steve Dean, MD, reminded FDA that many small hospitals are under immense budgetary pressures. "I would hate to see anything happen that would jeopardize continuing medical education efforts at the hospital level," Dean said. "As there are more and more regulations, it becomes more difficult to efficiently run an education department." New guidelines from the Accreditation Council for Continuing Medical Education are adequate to address FDA's concerns, many of the university hospital respondents said. The University of Pennsylvania CME department suggested "a period of 'watchful waiting' to see if the other guidelines in place do not serve the FDA's purposes in a less regulatory fashion." The University of Iowa agreed that revised CME guidelines developed by medical associations may meet FDA's goals as far as large CME bodies are concerned. However, Iowa noted, "it is common practice, especially among smaller community hospitals providing continuing medical education, to use drug-sponsored programs that in the past and at present may well violate" the updated guidelines. While the majority of comments from CME organizations generally opposed the guidelines as written ("The Pink Sheet" March 9, p. 5), there is support for the document even from rural areas. North Memorial Medical Center CME Director Seymour Handler, MD, commented: "We have never permitted sponsorship of CME by pharmaceutical companies" at his community hospital in Robbinsdale, Minn. Handler maintained that "sponsorship of CME is a...form of advertising, clearly not in the interest of the patient or objectivity."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts