May 15, 2007
CME authorities to consider stepping up vigilance
Stronger rules to prevent commercial bias in CME activities may be in the offing following a recent Senate inquiry into sponsored education.
At an upcoming meeting, the Accreditation Council for CME (ACCME)—the main accrediting body in CME—will ponder a number of “tactical responses” to preventing the outcome that the Senate Finance Committee has identified, said Murray Kopelow, MD, ACCME chief executive. “There is much being considered in response to communications we've gotten from the [committee],” he said.
Considerations include placing monitors in audiences, increasing transparency and toughening compliance requirements. These steps could put ACCME in a better position to address a major issue cited by the Senate in its April report: that some CME activities offered by accredited providers are improperly influence by commercial sponsors.
Kopelow added that ACCME has just finished the first round of making accreditation decisions using the updated Standards for Commercial Support: Standards to Ensure the Independence of CME Activities. The SCS were updated in 2004, requiring providers to disclose conflicts of interest. "Those data are being looked at, and we always modify, adjust around this time," he said. "This is exciting timing and will definitely enrich the discussions."
The FDA’s general counsel, Sheldon Bradshaw, said his agency also may rethink its rules concerning companies involved in funding education—encapsulated in a set of 1997 guidelines. “Does the FDA…need to be more vigilant in these areas? Perhaps,” he said.
The problem, according to Montana Democrat Max Baucus and Iowa Republican Charles Grassley—the chairman and ranking member of the Senate Finance Committee, respectively—is that regulatory authorities lack “real-time oversight” and that it can take up to nine years after a non-compliant activity to impose penalties.
As part of its process for determining whether accredited providers operate with the required level of independence, ACCME uses a self-study report, accreditation interview and a sample of CME activities. ACCME does not routinely place monitors in audiences, but that could change.
“Real-time oversight has several options available to it with a continuum of trained observers, using the audience, hired observers,” Kopelow told MM&M.
With respect to the time to enforcement, he said, “it’s true the path to non-accreditation can be long, but the time to correction of non-compliance is rapid.” He was referring to an internal progress report a provider files when it is found to be out of compliance. Such data has never been made public. Asked whether it could become transparent, Kopelow said ACCME will "definitely consider making public accreditation status and compliance findings of accredited providers to the extent that this might be of value to the system." Last year ACCME released composite compliance data, which show that medical education and communication companies (MECCs) are more compliant with SCS than other provider groups.
Another response to the Senate’s findings, Kopelow said, could be to raise the compliance threshold to 100%. Under current rules, an accredited provider can be deemed in compliance with ACCME standards even though 20% of its activities—assessed during the random sample—fail to comply with its standards. "We're being asked to...consider saying to the provider, 'Even in those [20% of] cases, you have not done it right every time, and you must do it right every time.' That’s worthy of our rules, that’s fair to providers and, yes, the board will consider what to do about this 80%.”
What’s motivating the rethink? Last December the Senate asked the ACCME to explain how it ensures independence. As it stands, ACCME still can’t produce evidence to assure the Senate that its activities are free of bias. “That’s a challenge for ACCME, both with respect to transparency and to its processes,” Kopelow acknowledged. But “being able to produce that data is part of the validation of the ACCME process itself and we take that very seriously and want to be able to respond.”
A response will come later this year, after the ACCME board meets July 18-20 in Chicago to set future strategic direction. The board, the governing body of ACCME comprised of 21 individuals who are nominated by seven member organizations and others, also will consider what to do next with comments received to two proposed policies, one of which would expand the definition of a “commercial interest.” This proposal is expected to result in compulsory firewall rules for MECCs, and comments received to the proposal have urged the board to consider applying any new rules to all providers.
The FDA took notice of the Senate report, too. “Certainly the FDA is going to consider that report in determining whether or not, for example, it makes sense to revise the 1997 guidance,” said Bradshaw. Whether its role will change significantly is less likely, though, as the agency maintains a more hands-off approach to education. Beyond providing basic guidance, the agency does not monitor that grants are used for bona fide education, as is spelled out in its 1997 guidelines. Speaking at IIR's Medical Education Congress in Philadelphia earlier this month, Bradshaw said that while the FDA has an interest in making sure CME is not a shill for promotion, “This is a complicated area. The agency itself is walking a delicate line in making sure we’re protecting the First-Amendment rights of [CME] providers."