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Sunday, 11/03/2019 7:47:22 AM

Sunday, November 03, 2019 7:47:22 AM

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A caption from a Medpage Today article from 2016:

"The FDA downplays the larger significance of the settlement but many observers see the start of a major shift away from strict FDA regulation of drugs. "This is a horrible precedent," said Steve Nissen, MD, of the Cleveland Clinic. "Off-label promotion of drugs isn't about freedom of speech, it's about misleading physicians and patients about the benefits and risks of treatments. 'Truthful' promotion of icosapent ethyl [Vascepa] would require Amarin to state that the drug has no proven benefits in patients with moderately elevated triglycerides." (Nissen disclosed that he is chairing a large 13,000 patient trial with a different fish oil drug, Epanova.)"
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