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  • Regulatory NewsRegulatory News

    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
  • Regulatory NewsRegulatory News

    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...
  • Regulatory NewsRegulatory News

    Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances

    With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label. Introduced in January, the draft Q&A documents detail how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well...
  • Regulatory NewsRegulatory News

    House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors

    While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians. GOP representatives have criticized FDA recently for failing to update its policies on off-label use communications as the agency has lost several recent court cases on the issue , and has questioned the need for loos...
  • Regulatory NewsRegulatory News

    New Report Investigates Drivers of Off-Label Prescribing in the EU

    A lack of incentives to go through the marketing authorization process to extend certain drug labels, as well as pricing and reimbursement issues, were cited as some of the varied drivers of off-label prescription drug use in the EU, according to a new report from the European Commission. “Data from scientific literature reveal that the prevalence of off-label use in the EU within the paediatric population is generally high, covers a broad range of therapeutic areas and...
  • 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...
  • Regulatory NewsRegulatory News

    FDA Questions Need for Looser Off-Label Promotion Restrictions

    Officials from the US Food and Drug Administration (FDA) last week questioned industry arguments for looser regulations on off-label promotion for drugs and devices at a two-day public hearing at FDA's White Oak campus. Currently, FDA limits companies' ability to promote products to their approved indications, and restricts the types of data companies can share that steps outside of the products' approved labeling. Background Earlier this year, FDA announced it was un...
  • Regulatory NewsRegulatory News

    Off-Label Promotion: Researchers Call on Courts to Reject Caronia

    Two researchers are calling for the US Food and Drug Administration (FDA) to take a stand against off-label promotion in light of recent legal proceedings, and urge the courts to reject the precedent set in United States v. Caronia . The call comes during a time of uncertainty for the future of off-label promotion and just one week before FDA's upcoming two-day public hearing on off-label communications. In Caronia , the Second Circuit Court of Appeals reversed the ...
  • 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...
  • Feature ArticlesFeature Articles

    Regulatory Advertising and Promotion: Exploring the Past and Present to Understand the Future

    This article provides a chronological overview of legislative milestones shaping the landscape of regulatory advertising and promotion. It reviews standards for prescription drug promotion and summarizes important cases involving off-label promotion with the purpose of showing that while interpretation for what is considered truthful and not misleading has been changing, regulations defining them have not changed. Introduction For those working in regulatory advertisi...
  • Regulatory NewsRegulatory News

    FDA Begins Process of Overhauling Off-Label Communications Regulations

    The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices. The hearing comes as FDA has come under fire recently for its limiting of what drug and device industries consider to be “free speech.” In March, FDA settled a lawsuit with drugmaker Amarin after the US District C...
  • Regulatory NewsRegulatory News

    Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing

    Illinois Attorney General Lisa Madigan on Thursday filed a lawsuit against Insys Therapeutics for deceptively marketing and selling its opioid Subsys (fentanyl), approved exclusively for the treatment of cancer pain, to physicians treating non-cancer patients for off-label uses like back and neck pain. Madigan alleges that Insys illegally marketed its painkiller to doctors who prescribed high volumes of opioid drugs instead of focusing its marketing on oncologists...