Category: Off-label Promotion

Off-label Promotion

Amarin Federal Court Decision: FDA Off-Label Marketing Rules Violate the First Amendment By John Kamp

Aug. 10, 2015 – Late last week the U.S. District Court for the Southern District of New York granted Amarin Pharma Inc.’s request for an injunction to stop the FDA from enforcing rules that prohibit companies from communicating to physicians truthful and non-misleading information about the off-label uses of their products. Below, Coalition for Healthcare […]

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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FDA Plans for Off-label Communication Draft Guidance, Meeting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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In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it “threaten[s] core First Amendment rights,” an amicus curiae brief filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) asks the U.S. District Court for the Eastern District of California to dismiss the case. PhRMA […]

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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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