July 6, 2021 – The authors of the 21st Century Cures Act, which passed with bipartisan support in 2015, now want to build on its success with new legislation that would improve clinical trials, provide information and training for patients and caregivers, and fund President Joe Biden’s concept for an Advanced Research Projects Agency for […]
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Special Report and Commentary from Jack Angel, Coalition for Healthcare Communication Education Foundation Executive Director Nov. 30, 2016 – As you may have seen, the language proposed for clarifying the intent of the educational provisions of the Sunshine Act have been stricken from the 21st Century Cures Act, which is scheduled for a vote […]
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May 31, 2016 – Although the U.S. Supreme Court and other courts consistently are deciding cases in favor of First Amendment protections for commercial speech – including speech about off-label uses – the movement toward a “truthful and non-misleading” standard has not moved the needle on this issue at the FDA, according to Alan Bennett, […]
Read moreJuly 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 moreMay 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 moreMay 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 moreMay 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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