Tag: First Amendment

First Amendment

DTC Advertising

Appeals Court Questions CMS Rule for DTC Ad List Prices

Appeals Court Questions CMS Rule for DTC Ad List Prices

Jan. 20, 2020 — A three-judge panel in the U.S. Court of Appeals for the District of Columbia sounded skeptical of the Trump administration’s position when it heard oral arguments last week in the government’s appeal of a U.S. District Court judge’s decision that struck down a Centers for Medicare & Medicaid Services (CMS) rule […]

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Courts/First Amendment

Three Manufacturers and ANA File Suit against CMS over Drug Price Disclosure Rule

Three Manufacturers and ANA File Suit against CMS over Drug Price Disclosure Rule

June 17, 2019 – The Trump administration’s final rule mandating that drug companies include the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) television ads for many drugs “exceeds [the Department of Health and Human Services’ (HHS’)] statutory authority, violates the First Amendment, and should therefore be set aside,” according to a lawsuit filed Friday, less […]

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CHC News

Coalition to CMS: Reprints, Medical Texts Are Not Sunshine Act Transfers of Value

Coalition to CMS: Reprints, Medical Texts Are Not Sunshine Act Transfers of Value

Nov. 12, 2018 — As part of the Trump administration’s deregulatory approach, the Centers for Medicare & Medicaid Services (CMS) has opened a period for comments on one aspect of the Sunshine Act—specifically, the reporting requirements for distribution of educational materials to physicians by industry. In its response to CMS, the Coalition for Healthcare Communication […]

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Regulatory/FDA

FDA Calls for Additional Comment on Revised Intended Use Language

FDA Calls for Additional Comment on Revised Intended Use Language

Jan. 15, 2018 – The FDA is delaying until further notice the effective date of a Jan. 9, 2017, final rule describing the types of evidence that may be considered in determining a medical product’s intended use so it can consider the comments and a citizen petition already received on that rule and collect additional […]

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Regulatory/FDA

FDA Study of Promotion Disclosure Needs to Address First Amendment, Other Issues

FDA Study of Promotion Disclosure Needs to Address First Amendment, Other Issues

Sept. 5, 2017 – An FDA-proposed study to determine whether healthcare professionals (HCPs) and consumers can utilize disclosures to correctly frame efficacy claims in prescription drug promotion raises First Amendment concerns about communication and requires fixes to the study construct, according to August comments on the June 14 proposal. “Disclosure is an important topic that […]

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