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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pinesIndustry More Than Ready for FDA Off-label Communications Guidance
Feb. 2, 2016 – The FDA’s recent announcement regarding which new and revised guidance documents it plans to publish in 2016 includes four long-awaited guidance documents by the Office of Prescription Drug Promotion (OPDP). “While the agency has been pondering its options, consumers and health professionals are expecting the industry to move forward and participate […]
Read moreFDA Plans for Off-label Communication Draft Guidance, Meeting
May 11, 2015 – With off-label provisions in the 21st Century Cures legislation in the works and the courts bearing down on the FDA regarding First Amendment protection of industry’s truthful, non-misleading speech about off-label uses of approved products, it appears that a bridge between the agency’s long-held positions and industry’s desire to speak to […]
Read moreFDA and Industry Priorities Do Not Always Match Up, Say D.C. Coalition Meeting Speakers
Oct. 8, 2013 – Although the Food and Drug Administration (FDA) has moved aggressively to approve new drugs recently, the FDA’s marketing policy priorities and its interpretation of the First Amendment do not always mesh with industry’s priorities, according to speakers at the Coalition for Healthcare Communication members meeting held recently in Washington, D.C. “Attendees […]
Read moreFDA States Keywords Do Not Have To Be Reported on Form 2253s
Sept. 3, 2013 – An FDA official’s statement during a recent enforcement Webinar that online keywords do not have to be submitted to the agency on FDA Form 2253s confirms – in the absence of explicit guidance from the FDA regarding Internet issues – what most in industry already had inferred from enforcement actions taken […]
Read moreOPDP Untitled Letters on PR Materials Surprise Industry
Nov. 27, 2012 – An Oct. 31 enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) to Cornerstone Therapeutics Inc. for CUROSURF Intratracheal Suspension sent a strong message to medical public relations professionals because it was one of two enforcement letters issued within a two-week period that cited press materials, not the advertising […]
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