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. 28, 2016 – Although President-elect Donald Trump was not who the Coalition for Healthcare Communication was preparing for in 2017, the organization will stay true to its mission of promoting and protecting the free flow of healthcare information under the Trump administration, according to Coalition Executive Director John Kamp, who spoke at the recent […]
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 […]
Read more Nov. 8, 2016 – When the votes are counted, expect many discussions on what will happen next. One thing is certain – there is change ahead. To get the real skinny on what will happen to medical marketing, attend the Coalition for Healthcare Communication post-election meeting next Wednesday and Thursday in Washington. Speakers from throughout […]
Read more
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
Oct. 3, 2016 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued just four enforcement letters in 2016, it remains focused on enforcement through other means, such as issuing guidance documents, and reviewing draft product labeling and launch materials to promote voluntary compliance, according to OPDP Director Tom Abrams. Abrams, who spoke […]
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 more