Daily News

Law Professor Lays Out Possible Defense Of FDA's Restrictive Off-Label Policies

October 11, 2017
While courts have struck down FDA's prohibition on off-label promotion based on First Amendment grounds, the agency has good standing to prohibit such actions when considering various canons of statutory construction, one law professor argues in a recently published University of Chicago Law Review article . FDA Commissioner Scott Gottlieb recently signaled FDA would rethink its approach toward off-label communication in light of recent court losses. While Gottlieb did not name cases, most proponents of off-label communication point to...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, news from FDA and much more.