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Case Detail


In re: Communications Regarding Off-Label Uses of Approved Medical Products
Case Date:
11/9/2016
Project Name:
In comments filed on December 30, 2016 in response to FDA’s September 1, 2016 formal request for comments on off-label communications, WLF argued that current restrictions prevent doctors from learning of the latest medical advances and violate First Amendment constraints on the government’s power to suppress truthful commercial speech. Both WLF's comments and testimony before a public meeting at the Food and Drug Administration on November 9, 2016 argue that doctors and other medical professionals appreciate the difference between FDA-approved uses (which must be validated by medical research whose costs often exceed one billion dollars) and off-label uses, and thus are unlikely to be misled by information that truthfully reports the results of clinical studies regarding the safety and effectiveness of off-label uses.
Case Status:
Awaiting FDA response.
More Information and Downloads:

For more on this case, visit:
https://wlflegalpulse.com/2016/11/09/wlf-testifies-at-fda-public-meeting-on-off-label-speech/

11/9/2016: Download Testimony
12/30/2016: Download the Comments
Press Release: WLF Urges FDA to Abide by First Amendment, Lift Restrictions on Off-Label Communications