Category: Courts/First Amendment

Courts/First Amendment

Courts/First Amendment

Three Manufacturers and ANA File Suit against CMS over Drug Price Disclosure Rule

Three Manufacturers and ANA File Suit against CMS over Drug Price Disclosure Rule

June 17, 2019 – The Trump administration’s final rule mandating that drug companies include the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) television ads for many drugs “exceeds [the Department of Health and Human Services’ (HHS’)] statutory authority, violates the First Amendment, and should therefore be set aside,” according to a lawsuit filed Friday, less […]

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Courts/First Amendment

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or off-label uses yesterday by extending the comment period related to the November 2016 hearing on this topic from Jan. 9 to April 19, and by issuing a 60-plus page memorandum that outlines the agency’s position […]

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Courts/First Amendment

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

Courts’ Support for “Truthful and Non-misleading” Speech Has Not Yet Resulted in FDA Policy Change

May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First Amendment protections for commercial speech – including speech about off-label uses – the movement toward a “truthful and non-misleading” standard has not moved the needle on this issue at the FDA, according to Alan Bennett, […]

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The Advertising Coalition Reminds FDA of First Amendment Limits to Advertising Regulation

May 9, 2016 – In an April 29 comment to the FDA on its recent proposal to conduct research on how animation in direct-to-consumer (DTC) prescription drug advertising affects viewer comprehension, The Advertising Coalition (TAC) asks the agency to consider the Office of Prescription Drug Promotion’s mission statement “in the context of a series of […]

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Commissioner of Food and Drugs Califf Lists Advertising, Labeling Among Priorities

April 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner of Food and Drugs Dr. Robert M. Califf stated that the agency’s current priorities include determining when advertising is false or misleading and addressing labeling and patient/consumer communication, among others. He also indicated that the […]

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Jury Says “Not Guilty” to Off-label Charges in Medical Device Case

March 3, 2016 – As the FDA fails to update or further clarify its policy regarding off-label promotion, the courts continue to hear cases that are being decided in favor of allowing.S. District Judge Royce Lamberth has entered an order dismissing the case; it is not subject to appeal. companies to share truthful and non-misleading […]

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Industry More Than Ready for FDA Off-label Communications Guidance

Feb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in 2016 includes four long-awaited guidance documents by the Office of Prescription Drug Promotion (OPDP). “While the agency has been pondering its options, consumers and health professionals are expecting the industry to move forward and participate […]

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Pacira Prevails in Exparel Settlement with FDA

Dec. 16, 2015 – Pacira Pharmaceuticals Inc. announced yesterday that it had reached a settlement with the FDA of a lawsuit it filed in September, which reaffirms the broad indications for Pacira’s non-opioid pain medication EXPAREL, results in the FDA’s rescission of a 2014 Office of Prescription Drug Promotion (OPDP) Warning Letter about the promotion […]

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Which Standard of Truth Will Be Used To Evaluate Non-misleading Ad Claims?

Oct. 5, 2015 – Following numerous First Amendment court cases about promotional speech decided in favor of pharmaceutical companies, it appears that the FDA may have to begin accepting alternative evidence to support truthful and non-misleading promotional claims, according to Douglas Hallward-Driemeier, partner, Appellate and Supreme Court Practice, Ropes & Gray. As demonstrated by the […]

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