June 14, 2018 – Although they may not be perfect, the two final guidance documents issued this week by the FDA do provide more information and examples to help pharma companies navigate how they communicate with payors and how they ensure that their on-label communications are compliant. In a June 12 statement, FDA Commissioner Scott […]
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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 […]
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April 11, 2017 – There is no doubt that the Trump administration is likely to change health policy in the near future, but the questions that remain to be answered are exactly what those changes will be and how they will affect healthcare communication. For predictions and insight from an expert panel of FDA and […]
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March 31, 2017 – With Congress in a seemingly permanent state of gridlock, individual states are taking actions that may affect how companies can communicate about their products within state borders. Arizona will soon become the first state to allow industry to communicate truthful off-label information about its products; Vermont has introduced a resolution calling […]
Read more 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 […]
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