In a corollary to its crackdown on drug-company-sponsored continuingmedical education, the Food and Drug Administration may restrictimaging vendors from exhibiting unapproved devices at medicalmeetings. The agency has established a device labeling
In a corollary to its crackdown on drug-company-sponsored continuingmedical education, the Food and Drug Administration may restrictimaging vendors from exhibiting unapproved devices at medicalmeetings. The agency has established a device labeling compliancebranch to monitor the new policy, which will be made formal inthe fall.
The move was not entirely unexpected. The FDA released preliminaryguidelines late last year for drug companies that sponsor CMEand other symposia. Most CME programs funded by corporate sponsorslack well-balanced content, rely too heavily on anecdotal data,fail to disclose study limitations and rarely discuss alternativeproducts, the agency said.
The FDA regulates drug and device promotion--not educationalsymposia. But some CME programs that rely on industry fundingfail to make a distinction between the two, the agency said. TheFDA's policy on CME content bars sponsors from any role in preparingCME presentations and bans speakers from discussing unapproveduses of a sponsor's products.
When the FDA's policy on drug-sponsored CME was first publicized,imaging vendors had little reason to be concerned, according toRobin Wiley, legislative assistant for regulatory affairs at theNational Electrical Manufacturers Association. The more recenttwist in FDA policy, however, will impact both imaging equipmentand drug companies.
Equipment vendors often exhibit their investigative systemsas works-in-progress at trade shows, and include information forgeneral consumption on initial clinical testing. The FDA restrictionsare intended to limit marketing of unapproved products to clinicalinvestigators only, Wiley said.
The American College of Radiology, which accredits educationalsymposia often sponsored by drug companies and imaging vendors,anticipated the new policy.
"Originally they were targeting pharmaceutical companies,but now the FDA is moving toward inclusion of imaging manufacturersas well. This is a very big issue," said Joanne Bresh, directorof CME for the ACR.
The FDA is accepting comments on the proposed policy change,which will include guidelines for devices subject to the 510(k)notification process.
A countersuit challenging Schering's gadolinium-based patentshas also been rumored. Neither Schering nor Sterling representativeshave returned calls requesting confirmation of this report.