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  • Regulatory NewsRegulatory News

    FDA Delays Implementing Parts of 'Intended Use' Rule

    Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration (FDA) to delay indefinitely the implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used. "This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determi...
  • Regulatory NewsRegulatory News

    Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications

    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? FDA on Wednesday attempted to answer these questions and more with the release of two new draft guidance documents and a 63-page memorandum on public health interests and First Amendment considerations related to off-label communica...
  • Feature ArticlesFeature Articles

    Do Recent First Amendment Court Developments Deal a Blow to the Government?

    This article discusses the Amarin/FDA court settlement, the verdict in favor of Vascular Solutions and other developments relating to off-label promotional communications. Introduction The US Food and Drug Administration has suffered two widely-publicized setbacks relating to off-label promotion oversight. In both cases—one involving a pharmaceutical company (Amarin) and the other a medical device firm (Vascular Solutions) and its chief executive officer—the governmen...
  • Regulatory NewsRegulatory News

    Harvard Professors Call for Science-Based Pharma Marketing

    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.” Background The US Food and Drug Administration (FDA) generally does not allow pharmaceutical companies to promote drugs for unappro...
  • Regulatory NewsRegulatory News

    Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

    • 28 August 2014
    • By
    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. Now the US pharmaceutical industry's largest group, PhRMA, is weighing in on the guidance, giving it rare praise for what it calls the gu...
  • Regulatory NewsRegulatory News

    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...
  • Regulatory NewsRegulatory News

    Legal Group to FDA: Reprint Guidance Violates First Amendment, Existing Court Order

    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. But in the case of a recent response to a new guidance on distributing reprints of scientific and medical literature, one group's message for FDA is a bit more confrontational: Make changes to the guidance— or else . Background In February 2014, FDA released a new draft guida...
  • PhRMA: FDA Labeling Guidance May Run Afoul of First Amendment, Discounts Value of 'Trade Dress'

    The pharmaceutical industry group Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on the US Food and Drug Administration (FDA) to make several changes to a recent guidance for industry document intended to reduce medication errors by standardizing the way information is displayed on labels and cartons-not just the labeling itself. Background The guidance document, Safety Considerations for Container Labels and Carton Labeling Design to Minimiz...
  • New FDA Staff Policy Manual Defines 'Major Amendments' to Generic Drug Submissions

    The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD) has released a new guideline for its internal review staff on how to handle amendments to generic drug applications. The Manual of Policies and Procedures (MAPP), Reviewer Determination of Major/Minor Amendments to Abbreviated New Drug Applications , is specifically intended for OGD's chemistry review staff. After submitting an original or supplemental Abbreviated New Drug Application (ANDA), ...
  • Researcher: Regulations Banning Gifts Unlikely to Pass Constitutional Muster

    • 14 June 2012
    • By
    Is a free donut an expression of free speech? At least one expert thinks so, and the strength of her argument could have a wide-ranging impact on the ability of states to regulate gifts from the pharmaceutical and medical device industry to physicians and academia. Writing in the June 2012 issue of the Journal of Health and Biomedical Law , Marcia Boumil, JD, an associate professor at the Tufts University School of Medicine, argues recently-established judicial preceden...
  • PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

    The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech. FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, " New FDA Draft Guidance on DTC Television Advert...
  • Ruling on Tobacco Products Could Have Broader Implications for FDA

    A ruling by the DC Circuit Court of Appeals could have broader implications for the US Food and Drug Administration's attempts to regulate products by mandating uniform labeling. In a decision, Judge Richard Leon ruled that FDA was not lawful when it required cigarette companies to label their tobacco products with graphic, shocking images . "The government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that t...