Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in violation of the Administrative Procedures Act because it deprives stakeholders of fair notice and the opportunity to comment, according to a Feb. 8 […]
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Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the end of 2016, the Office of Prescription Drug Promotion (OPDP) fell short of that goal and apparently will set a very low bar for 2017: It plans to issue only one guidance document in 2017. […]
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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 […]
Read more Dec. 15, 2016 – The FDA announced that it would extend the comment period on manufacturer communication regarding unapproved uses of medical products by another 90 days, further delaying any agency action on the matter after a prolonged wait by industry for guidance. “We are taking this action to allow interested persons additional time to […]
Read more Nov. 10, 2016 – As FDA Commissioner Robert Califf described the issues surrounding the communication of off-label uses as “numerous and complex” and cautioned that there are many instances where unapproved uses are “unsafe and ineffective,” industry speakers at an FDA hearing held Nov. 9 called on the agency to take immediate action and provide […]
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Oct. 31, 2016 – In testimony at the upcoming off-label hearing at the FDA, Coalition for Healthcare Communication Executive Director John Kamp will emphasize that FDA must quickly develop rules that are clear and consistent with the First and Fifth Amendments. The FDA today released the draft agenda for its two-day meeting on manufacturer communication […]
Read more 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 […]
Read moreMarch 3, 2014 – The FDA announced today the availability of a new draft guidance (2014-04560) on distributing scientific and medical publications on unapproved uses that updates a 2009 draft guidance on the topic, provides recommended practices for the dissemination of scientific or medical journal articles and scientific or medical reference texts and, importantly, adds […]
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