Tag: kamp

kamp

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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Pacira Prevails in Exparel Settlement with FDA

Dec. 16, 2015 – Pacira Pharmaceuticals Inc. announced yesterday that it had reached a settlement with the FDA of a lawsuit it filed in September, which reaffirms the broad indications for Pacira’s non-opioid pain medication EXPAREL, results in the FDA’s rescission of a 2014 Office of Prescription Drug Promotion (OPDP) Warning Letter about the promotion […]

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AMA Calls for DTC Advertising Ban

Nov. 17, 2015 — The American Medical Association (AMA) announced today that it would support an advertising ban on direct-to-consumer (DTC) advertising in an effort to make prescription drugs more affordable and address member concerns regarding “the negative impact of commercially-driven promotions and the role that marketing costs play in fueling escalating drug prices.” The […]

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Kaiser Poll: DTC Ads Have High Profile, But Mixed Reviews

Oct. 30, 2015 – The drug industry may have additional work to do to improve the public’s perception of its advertising, according to Kaiser Health Tracking Poll findings reported Oct. 28. Although a high percentage of the public (82 percent) reports having seen or heard a prescription drug direct-to-consumer (DTC) ad, only 51 percent of […]

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Prescription Drug Marketing Targeted by Hillary Clinton

Sept. 24, 2015 – Presidential hopeful Hillary Clinton just announced that she would “demand a stop to excessive profiteering and marketing by denying tax breaks for direct-to-consumer [DTC] advertising and demanding that drug companies invest in R&D in exchange for taxpayer support,” according to a briefing released this week by her campaign. Under Clinton’s plan, […]

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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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