Oct. 19, 2018 — The FDA’s Office of Prescription Drug Promotion (OPDP) issued two enforcement actions in less than a week that focused on alleged safety and risk information infractions for products with Boxed Warnings; both matters were brought to the agency’s attention through OPDP’s Bad Ad program. “These letters are significant not because they […]
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Jan. 22, 2018 – The House Energy and Commerce Subcommittee on Health held a markup Jan. 17 that advances H.R. 2026 (http://bit.ly/2G4cRM1), the “Pharmaceutical Information Exchange Act,” which will clarify how drug and medical device companies can share health care economic or scientific information about investigational drugs or devices with payers and formulary committees. “By […]
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July 14, 2017 – Members of the House Energy and Commerce Health Subcommittee on Health and those providing testimony about two pieces of off-label communication legislation held positions that fell into two camps at a July 12 hearing: (1) Those who believe the current regulatory scenario for off-label communication is nimble and protects the public […]
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May 30, 2017 — In response to former FDA Commissioner Robert Califf’s recent call for the Coalition for Healthcare Communication to establish a code of ethics for members, several industry leaders on the CHC’s executive committee indicated that such a code strikes a responsive chord (see related article at http://www.cohealthcom.org/?p=3586). At the Coalition’s May 15 […]
Read moreMay 18, 2017 – At this week’s information-packed Coalition for Healthcare Communication’s Rising Leaders Conference, keynote speaker and former FDA Commissioner Robert Califf said that “healthcare marketers need to create a code of ethics to promote drugs for truthful and non-misleading uses outside their FDA-approved labels, commonly referred to as off-label promotion,” according to coverage […]
Read more 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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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 […]
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