Tag: off-label

off-label

Industry 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 […]

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House Approves 21st Century Cures Act, Bill Now Heads to the Senate

July 10, 2015 — The House of Representatives today passed H.R. 6, also known as the 21st Century Cures Act, by an overwhelming majority of 344-77. The legislation, which includes three provisions that are important to healthcare marketers, now heads to the Senate. The bill’s authors, House Energy and Commerce Committee Chairman Fred Upton (R-Mich.), […]

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House Energy and Commerce Committee Wholeheartedly Approves 21st Century Cures Act

May 21, 2015 – In a unanimous (51-0) vote today, the House Energy and Commerce Committee approved the 21st Century Cures Act, which includes three closely followed provisions on off-label communication and Sunshine reporting. The bill, which stretches over 300 pages, also includes a broad array of amendments related to the National Institute of Health […]

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21st Century Cures Legislation Poised for Full House Committee Vote This Week

May 18, 2015 – Major medical legislation, including closely followed provisions on off-label communication and Sunshine reporting, survived a House Energy and Commerce Committee vote last week, is set for a full committee vote this week, and could be up for a full House vote early this summer. The 21st Century Cures Act, championed by […]

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FDA Plans for Off-label Communication Draft Guidance, Meeting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 […]

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PhRMA Authors Call for FDA to Establish Off-label Communication Safe Harbor

April 27, 2015 – Because “sharing more information rather than less” about the off-label uses of approved drugs “is critical to healthcare delivery,” the FDA should interpret the Federal Food, Drug & Cosmetic Act “in a way that creates a clear, meaningful safe harbor for manufacturers to share with healthcare professionals a much greater amount […]

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Doctor Tells Congress That Communication Is Hampered by FDA, CMS Practices

July 28, 2014 – FDA and Centers for Medicare & Medicaid Services (CMS) policies are barriers to ongoing evidence development and communication, Dr. Gregory Schimizzi told the House Energy and Commerce Committee’s Subcommittee on Health July 22 at a hearing to explore “21st Century Cures.” Schimizzi, a member of the board of directors and past […]

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Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, Coalition for Healthcare Communication Executive Director John Kamp told The Washington Post last week. In the July 9 article, “FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules,” Kamp and […]

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