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CHC News

Purple Strategies’ Haynes to Keynote at CHC Member Meeting in D.C.

Purple Strategies’ Haynes to Keynote at CHC Member Meeting in D.C.

Sept. 29, 2016 — Bruce Haynes, founding partner and president of Purple Strategies, will give the keynote address at the Coalition for Healthcare Communication Member Meeting to be held in Washington, D.C., on Nov. 15-16. Haynes works with some of the world’s best-known brands in the areas of strategy and message development, research, advertising, media […]

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Off-label Promotion

FDA to Hold Post-election Hearing on Off-label Communication

FDA to Hold Post-election Hearing on Off-label Communication

Sept. 1, 2016 – In the wake of the agency’s recent settlement with Amarin and other rulings that support the “truthful and non-misleading” communication of unapproved uses, industry has been anxiously awaiting the FDA’s next move, especially after the agency stated in May 2015 that it would hold a hearing on this matter. The wait […]

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Medical Associations Support Bill Exempting Journals and Textbooks from Sunshine Reporting

July 15, 2016 – More than 100 medical associations, including the American Medical Association, signed a letter of support for S. 2978, a bill sponsored by Sen. John Barrasso, M.D. (R-Wyo.), that would exempt peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks from being reported as transfers of value under the […]

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Pfizer Gets in Front of Opioid Marketing Issue

July 8, 2016 – As organized medicine, politicians and the public seek to reverse the scourge of opioid addiction, Pfizer made a move that shows a good-faith effort to become a part of the problem’s solution. The company signed an agreement June 30 with the City of Chicago to follow a written code of conduct […]

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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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DeLauro's House Bill to Restrict DTC Advertising Likely Would Violate First Amendment

Feb. 18, 2016 – A bill introduced in the House last week by Rep. Rosa DeLauro (D-Conn.) — the Responsibility in Drug Advertising Act of 2016 (H.R. 4565) – would prohibit direct-to-consumer (DTC) advertising for the first three years following a drug’s approval and allow the Department of Health and Human Services (HHS) to waive […]

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