Arch Pathol Lab Med. 2013 Mar 15. [Epub ahead of print]
US Food and Drug Administration-Approved Laboratory Tests After Caronia.
Source
From the Department of Pathology and Laboratory Medicine, The University of Texas Health Science Center at Tyler.
"Caronia changed the paradigm, freeing drug vendors to speak openly, with First Amendment protection, about FDA-approved and FDA-nonapproved (‘‘off-label’’) uses for drugs and medical devices. The success of ‘‘companion tests’’ has depended on the pre-Caronia environment allowing the FDA to restrict speech about alternative, offlabel tests; however, now that Caronia allows truthful, nonmisleading speech about these other tests, the marketing appeal of the companion test may rapidly wane. Taken in full, the holding could eliminate the newly minted companion test entirely, by eliminating the FDA-produced monopoly incentives that come with a test being labeled a companion test."
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