Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
Objectives ⢠New drug approval process ⢠Pricing of new drugs ⢠Off ...
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3/15/13%<br />
On December 3, 2012, a divided Second Circuit held<br />
in United States v. Caronia (“Caronia”) that the<br />
misbranding provisions <strong>of</strong> the Federal Food, Drug,<br />
and Cosmetic Act (“FDCA”) do not criminalize “the<br />
truthful <strong>of</strong>f-label promotion <strong>of</strong> FDA-approved<br />
prescription <strong>drug</strong>s.” The two-judge majority based its<br />
holding primarily on last year’s Supreme Court<br />
decision in Sorrell v. IMS Health, Inc., which held that<br />
“[s]peech in aid <strong>of</strong> pharmaceutical marketing…is a<br />
form <strong>of</strong> expression protected by the Free Speech<br />
Clause <strong>of</strong> the First Amendment.”<br />
http://www.jdsupra.com/legal<strong>new</strong>s/<strong>of</strong>f-label-marketing-questioned-as-a-viab-49267/<br />
20%
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