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Drug & Device News
Manufacturer Goes to Court to Challenge FDA's Restrictions on Off-Label Drug Use Promotion
In a May 7 filing with the U.S. Securities and Exchange Commission (SEC), the pharmaceuticals manufacturer Amarin Pharma, Inc., a wholly-owned subsidiary of Amarin Corporation Plc, announced that it had filed suit in the U.S. District Court for the Southern District of New York seeking a declaration permitting it to share truthful and non-misleading information about its drugs with U.S. health care professionals, even if the Food and Drug Administration (FDA) considers those declarations non-permissible promotion of off-label drug use. The lawsuit claims that regulation of truthful and non-misleading information is unconstitutional under the First Amendment ' because it curtails freedom of speech ' and under the Fifth Amendment ' because the FDA's regulation is vague as applied to the company's proposed promotion of its drug, Vascepa, a prescription omega-3 fatty acid.
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