[governance] US Food and Drug hearings

[Sylvia Caras]

FDA has established public docket FDA- 2009-N-0441 to receive public 
comment on promotion of FDA-regulated medical products (including 
prescription drugs for humans and animals, prescription biologics, 
and medical devices) using the Internet and social media tools.

"Although FDA has not comprehensively addressed when Internet
promotion of prescription drugs and medical devices is labeling versus
advertising, the agency has jurisdiction over all prescription drug and
biologic product promotion as well as all restricted device advertising
and all device promotional labeling when conducted by or on behalf of a
manufacturer, packer, or distributor. There are no regulations that
specifically address Internet promotion separately from the other types
of promotion discussed above, nor are there any regulations that
prohibit the use of certain types of media to promote drugs and medical
devices. Although no rule has specifically addressed Internet
promotion, it is fairly clear that some promotional efforts are
substantially similar in presentation and content to promotional
materials in other media or publications. At the same time, FDA
recognizes that the Internet possesses certain unique technological
features and that some online tools that may be used for promotion
offer novel presentation and content features. Another emerging issue
involves the reporting of adverse event data because such information
may initially be revealed using social media platforms in the context
of Internet promotion for FDA-regulated medical products."

<http://edocket.access.gpo.gov/2009/E9-22618.htm>http://edocket.access.gpo.gov/2009/E9-22618.htm 

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