Tag: off-label

off-label

WLF: FDA’s Revised Reprint Draft Guidance Violates Injunction and First Amendment

May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles and medical texts that contain off-label information, the Washington Legal Foundation (WLF) stated that as written, the draft guidance violates a 1999 federal court injunction that prohibits the agency from preventing manufacturers from disseminating peer-reviewed […]

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FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in line with the most recent First Amendment case law, according to FDA senior officials who spoke recently at the Food and Drug Law Institute’s Annual Meeting held in Washington, D.C. On April 23, Leslie Kux, […]

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Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label uses is a “baby step” forward, Coalition for Healthcare Communication Executive Director John Kamp told The Wall Street Journal (WSJ) last week. In a March 25 WSJ “Corporate Intelligence” blog post written by former Pharmalot […]

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Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to participate in this year’s CMS/FDA Summit, produced by the editors of The RPM Report. Among the most interesting panel presentations was that titled “Beyond the Label,” featuring Mit Spears, General Counsel of the Pharmaceutical Research […]

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MIWG Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information

Sept. 16, 2013 – The Medical Information Working Group (MIWG), a coalition of medical product manufacturers seeking to improve the regulatory and enforcement environment for communications about new uses for approved or cleared products, has asked the FDA Center for Drug Evaluation and Research’s (CDER’s) Medical Policy Council to take “immediate action … to assure […]

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Kamp in MMM: Off-label Is on the Table

May 14, 2013 — In a Medical Marketing and Media (MMM) column posted May 1, Coalition for Healthcare Communication Executive Director John Kamp said that “although the FDA has been able to cling for decades to the idea that the approved label constitutes virtually the only truth about an approved product, good common sense and […]

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Federal Appeals Court Reverses Conviction of Detailer for “Off-label” Promotion

Regulation of Pharma Speaker’s Truthful Message Violates the First Amendment Dec. 3, 2012 – The U.S. Court of Appeals for the Second Circuit released a long-awaited decision today reversing the conviction of Alfred Caronia, a detailer for Orphan Medical Inc., who admitted that he intentionally promoted Xyrem for uses not approved by the FDA. The decision […]

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