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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off-labelHouse 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.), […]
Read moreHouse 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 […]
Read more21st 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 […]
Read moreFDA Plans for Off-label Communication Draft Guidance, Meeting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 morePhRMA 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 […]
Read moreDoctor 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 […]
Read moreKamp 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 […]
Read moreHouse Committee Seeks Patient Input on Availability of Treatments
June 3, 2014 – The House Energy and Commerce Committee is seeking public comments from patients, providers and other stakeholders about how they learn about new treatments for their diseases or conditions, a discussion that is likely to fuel the debate over whether and how companies can disclose information about off-label uses for their products. […]
Read moreNew Yorker Article Weighs Sales Rep Free Speech Arguments in Off-label Context
May 22, 2014 – Both sides of the argument over whether sales representatives’ speech about off-label drug uses are protected by the First Amendment are addressed in a May 21 posting in The New Yorker. The author summarizes the recent U.S. Supreme Court decisions in IMS V. Sorrell and in U.S. v. Caronia that could […]
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