by Kyle Deighan
On October 14, Par Pharmaceutical, Inc. ("Par") filed a complaint against the United States of America and the Food and Drug Adminstration ("FDA") seeking a declaratory judgment that the first amendment bars the FDA from criminalizing pharmaceutical manufacturers for making statements regarding so called "off-label promotion" of approved drugs. Par argues that "the ongoing threat of prosecution for alleged off-label promotion based on Par's truthful and non-misleading speech to healthcare professionals concerning the FDA-approved use of Par's FDA-approved prescription drug currently chills Par's speech. Par seeks declaratory and injunctive relief to ensure its ability to engage in this protected speech free from the risk of criminal liability."
Par seeks this relief to allow it to discuss "off-label" uses for its drugs, which refers to use of the product outside that approved by the FDA. According to the complaint, off-label use is widespread and widely accepted by healthcare professionals, the U.S. government, and even the FDA. Par states that "FDA itself has recognized that 'in certain circumstances, off label uses of approved products are appropriate, rational, and accepted medical practice. FDA knows that there are important off label uses of approved drugs.'" Further, Par explains that the government encourages off-label use as well, as many off-label uses are subsidized by the federal government under the Medicare and Medicaid programs.