• Regulatory NewsRegulatory News

    FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity

    The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity.  “The first type of adverse event involves the fluid-filled intragastric balloon over-inflating with air or with more fluid (spontaneous hyperinflation) in patients’ stomachs, resulting in the need for premature device removal...
  • Regulatory NewsRegulatory News

    Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know

    The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions." FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously ...
  • Are Regulators and Payers Aligned to Allow Manufacturers of Obesity Treatment Devices to Innovate?

    US regulators announced Tuesday that they soon plan to hold a workshop on the treatment of metabolic diseases, a meeting originally scheduled to be held during the government shutdown. Background Metabolic diseases and disorders refer to a broad spectrum of medical conditions which generally result in obesity and other health problems, such as heart disease and diabetes. As one of the fastest-growing health problems in the US and around the world, obesity has commanded ...
  • FDA Wants to Know: Do US Regulations Promote Innovation for Devices Intended to Treat Obesity?

    The US Food and Drug Administration (FDA) is looking to tackle something of an unusual target at an upcoming meeting between the regulator, the American Gastroenterological Association (AGA) and the public: Reimbursement issues. Background It's a relatively uncommon-though not unprecedented-issue for FDA to address given its mission to regulate the safety and efficacy of healthcare products, and not their eventual cost. In recent years a number of entities, including ...
  • Report: FDA Considering New Approval Paradigm for Socially Beneficial Drugs

    • 12 October 2012
    The US Food and Drug Administration (FDA) is considering allowing sponsors of select therapies to conduct smaller, faster clinical trials in return for a more restrictive labeling convention that would initially limit its use to a narrower group of patients, FDA Commissioner Margaret Hamburg told a group of scientific advisors. The remarks, reported by Bloomberg , potentially mark a paradigm shift for FDA, which has historically granted marketing licenses for new pr...
  • FDA Reviewers Explain Agency's New Obesity Drug Paradigm in NEJM

    • 11 October 2012
    Six drug reviewers with the US Food and Drug Administration (FDA) have written an explanation of the safety and efficacy paradigm used to assess new anti-obesity therapies and approve two new obesity drugs-the most approved in one year since a number of high-profile safety concerns resulted in many of the drugs being withdrawn from the market. The graveyard of such therapies is well populated. Aminorex, a stimulant, was withdrawn in 1972 after it was shown to cause pul...
  • After Failures, EMA Calls for Overhaul of Existing Obesity Treatment Guidance

    A new concept paper released by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) seeks to establish an updated framework for anti-obesity and weight control drug products. In its 1 October concept paper, " Concept paper on the need for revision of the guideline of medical products used in weight control ," CHMP looks to a November 2007 guideline on weight control, noting that two weight control products have been pulled from the marke...
  • FDA Approves Vivus' Obesity Weight Loss Drug Qsymia

    The US Food and Drug Administration (FDA) on Tuesday, 17 July approved Vivus Inc's Qsymia, formerly known as Qnexa, for the treatment of obesity. The drug's approval marks FDA's second diet drug approval in as many months after a 13-year drought during which no diet drugs were approved by the agency. The agency said the drug, a combination of phentermine and topiramate extended-release, is intended for the treatment of adult with a BMI of 30 of greater, or 27 of greater ...
  • US Regulators Approve First Obesity Drug in 13 Years

    In a possible shift its existing policy framework, the US Food and Drug Administration (FDA) has approved Arena Pharmaceuticals' anti-obesity drug Belviq (lorcaserin), making it the first anti-obesity drug to be approved in 13 years. The drug was subject to concerns-as are many anti-obesity drugs-about cardiovascular risks to patients, and at least one public advocacy group had urged FDA not to approve the drug based on those concerns. FDA seemed to take those risks...
  • FDA Panels Clear Arena Pharmaceuticals' Obesity Drug, Gilead Sciences' HIV PrEP

    Advisory Committees for the US Food and Drug Administration (FDA) cleared two high-profile pharmaceutical products on 10 May that would, respectively, help patients to lose weight and prevent patients from contracting the Human Immunodeficiency Virus. Arena Pharmaceuticals' Lorcaserin: The New York Times : "Government advisers recommended approval on Thursday of a weight-loss drug developed by Arena Pharmaceuticals, making it likely that a new obesity trea...
  • Fed Up With Medical Device Lag, Some Patient Seek Obesity Treatment in Canada

    A weight loss treatment available in Canada but not yet approved in the US is leading some patients to seek treatment across the border, reports The New York Times . The Times highlights the case of intragastric balloons, which were once available in the US before being taken off the market by its manufacturer, American Edwards Laboratories, in 1988. The devices are implanted in the stomach by way of the esophagus and filled with fluid. The device has since been appr...
  • Obesity Drug Gets FDA Panel Support

    • 23 February 2012
    Advisors to the Food and Drug Administration (FDA) have recommended the obesity drug Qnexa for approval, according to a report by Pharma Times Online . The prescription diet drug manufactured by Vivus is on track to be the first to reach the US market since 1999. The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of the drug, stating the benefits outweigh the risks. Pharma Times Online reported that the panel stressed to the company that ...