Search Results for First Amendment

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FDA Delays Implementing Parts of 'Intended Use' Rule By Zachary Brennan - Published 12 January 2018

Confusion and concerns over portions of a tobacco-related final rule that could have major ramifications for the medical product industries has pushed the US Food and Drug Administration (FDA) to delay the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: intended use, First Amendment, FDA rule

Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications By Zachary Brennan - Published 18 January 2017

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public, be considered in violation of the law or US Food and Drug Administration (FDA) regulations?

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Labeling, Regulatory intelligence, Regulatory strategy

Tags: off-label drug communications, off-label marketing, First Amendment and pharmaceuticals, FDA guidance

Do Recent First Amendment Court Developments Deal a Blow to the Government? By Alan Minsk, Kelley Nduom - Published 05 October 2016

This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications.

Categories: Features, US, FDA, Advertising and Promotion, Communication, Drugs, Government affairs

Tags: Amarin, Pacira, Vascular Solutions, First Amendment, Off-label promotion

Harvard Professors Call for Science-Based Pharma Marketing By Zachary Brennan - Published 16 March 2016

Two Harvard professors are taking issue with the recent landmark court decision allowing some "truthful and non-misleading" off-label pharmaceutical marketing in a new paper, saying “informativeness in asserting scientific facts, rather than truthfulness, ought to be the gold standard for evaluating commercial speech about pharmaceuticals.”

Categories: News, US, FDA, Advertising and Promotion, Drugs, Government affairs

Tags: Amarin, First Amendment, off-label marketing, pharmaceutical speech

Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further Published 28 August 2014

Earlier this year, the US Food and Drug Administration (FDA) released a much-anticipated draft guidance document which could potentially expand the ways in which pharmaceutical and medical device companies could distribute information regarding the safety of their products, even if that information isn't for an FDA-approved indication.

Categories: News, US, CDER, Biologics and biotechnology, Prescription drugs, Labeling

Tags: PhRMA, Reprint Guidance, First Amendment, Free Speech, Guidance, Draft Guidance

Legal Group to FDA: Reprint Guidance Violates First Amendment, Existing Court Order By Alexander Gaffney, RAC - Published 16 May 2014

Public comments submitted to the US Food and Drug Administration (FDA) regarding its guidance documents are generally tame, referring to matters for preference or a need to clarify vague sections.

Categories: News, US, CBER, CDER, Labeling

Tags: First Amendment, Reprints, Scientific Literature, Guidance

PhRMA: FDA Labeling Guidance May Run Afoul of First Amendment, Discounts Value of 'Trade Dress' By Alexander Gaffney, RF News Editor - Published 30 July 2013

Categories: US, FDA, Labeling

Tags: Carton, First Amendment, PhRMA, draft guidance

Researcher: Regulations Banning Gifts Unlikely to Pass Constitutional Muster By Alexander Gaffney - Published 14 June 2012

Tags: Sorrell, Unconstitutional, Constitutional, Free Speech, Gifts, First Amendment, Latest News

PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights By Alexander Gaffney - Published 21 May 2012

Categories: FDA

Tags: Narrowly Tailored, Free Speech, First Amendment, DTC, PhRMA, Latest News, draft guidance, advertising, guidance

Ruling on Tobacco Products Could Have Broader Implications for FDA By Alexander Gaffney - Published 01 March 2012

Categories: FDA, Labeling

Tags: First Amendment, Leon, Ruling, Court, Latest News, Cigarettes