Archives: First Amendment

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Industry Guidance on Unapproved or Off-Label Information Provides Insight Into Issues Under FDA Review

As we recently reported, in the wake of court rulings and settlements addressing the First Amendment in the context of providing truthful, non-misleading speech, including about unapproved (or, “off-label”) use of approved or cleared medical products, on September 1, 2016, the FDA issued a notice that it will hold a public hearing on November 9 and … Continue Reading

FDA Issues Long-Awaited Draft Guidance Documents Concerning Internet/Social Media

Recently, the United States Food and Drug Administration (FDA) released two long-awaited draft guidance documents pertaining to internet and social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices Internet/Social Media Platforms with Character Space Limitations–Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The first draft guidance … Continue Reading

Par Pharmaceutical Pleads Guilty and Agrees to Pay $45 Million to Resolve Off-Label Promotion Claims

On March 5, 2013, DOJ announced that manufacturer Par Pharmaceutical pleaded guilty to a criminal misdemeanor charge for misbranding with respect to its product Megace ES (megestrol acetate).  Par agreed to pay $45 million and entered into a five-year corporate integrity agreement.  The settlement also resolves the suit Par filed against FDA in 2011 concerning … Continue Reading

Harkonen Fails to Shed Light on Commercial Speech Issues

On March 4, 2013, the Ninth Circuit affirmed the conviction of former InterMune President and CEO W. Scott Harkonen for wire fraud.  As we have previously noted, this pharmaceutical promotion case could have clarified commercial speech issues, such as the scope of First Amendment rights for scientific speech.  These issues are relevant not only to drug promotion but also … Continue Reading

Caronia Update: Government Does Not Appeal Significant Second Circuit Decision

The federal government will not appeal the decision of a Second Circuit panel in United States v. Caronia.  The government did not petition for rehearing by the panel or the en banc Second Circuit before the January 16 deadline.  Further, the Wall Street Journal and others are reporting that FDA officials have confirmed that the government … Continue Reading

U.S. v. Caronia: Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a significant opinion in United States v. Caronia, concerning the application of the First Amendment to off-label promotion.  The court held that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act] for … Continue Reading
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