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  • In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

    • 04 December 2012
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    In a potentially landmark ruling, the US 2 nd Circuit Court of Appeals has reversed a lower court's finding that a pharmaceutical sales representative was guilty of promoting off-label uses for certain approved drug products, finding that the government's actions had violation the man's right to free speech. Many analysts questioned whether the ruling could eventually lead to a sea change in the way drug promotion is conducted in the US. Currently, companies are not a...
  • Pfizer's Cyklokapron Green Lighted for Off-Label Use by NHS

    The UK's cost containment agency, the National Institute for health and Clinical Excellence (NICE), has published supporting evidence for the off-label use of Pfizer's Cyklokapron by the National Health Service (NHS) for significant severe bleeding following trauma.   The publication is the first edition of what NICE calls the Evidence Summary, which summarizes the published evidence for the off-label use of medicines for indications for which there are no...
  • French Regulators Launch New Prescription Drug Paradigm Aimed at Limiting Off-Label Use

    • 08 October 2012
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    In the wake of a drug safety scandal that brought down an entire regulatory agency, France's new healthcare product regulatory body, ANSM, is moving to fundamentally change the way it regulates the use and surveillance of off-label prescription drug products, reports the New England Journal of Medicine (NEJM) . France's previous regulatory agency, AFSSAPS, was reconstituted in May 2012 as the National Agency for the Safety of Medicines and Health Products (ANSM) after...
  • Abbott Hit with $1.5 Billion Fine for Off-Label Marketing

    Life sciences manufacturer Abbott has pleaded guilty to charges of unlawfully promoting its anti-seizure drug Depakote (divalproex sodium) and will pay a total of $1.5 billion in fines and be subject to a five-year probationary period, the Department of Justice (DOJ) announced on 2 October. Under the settlement, Abbott will pay a $500 million criminal fine, forfeit $198.5 million in earnings and pay $800 million to state and federal government. The fines and penalties...
  • Warning Letter Forms Partial Basis for Corporate Takeover Attempt

    • 14 August 2012
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    A warning letter sent to Forest Laboratories by the US Food and Drug Administration (FDA) is fueling the latest salvo in a long-running proxy battle between activist investor Carl Icahn and the company. Icahn has for months been trying to take control of the company through its board of directors, saying the company has been underperforming to the detriment of its shareholders. On 13 August, Icahn blasted the company , saying it had failed to disclose a warning let...
  • Abbott Slammed with $1.5 Billion Fine for Off-label Depakote Marketing

    Pharmaceutical manufacturer Abbott Laboratories has agreed to pay a near-record $1.5 billion in fines for the off-label promotion of its anti-seizure drug Depakote, with the total to be split between the federal government, states and consumers. In a lengthy statement released by the Department of Justice (DOJ), Deputy Attorney General James M. Cole called the settlement a "strong message to other companies" not to engage in fraud. DOJ explained in its statement that ...
  • Study: Canadian Off-Label Prescribing Common, Lacks 'Strong Scientific Evidence'

    A new study released in the medical journal Archives of Internal Medicines finds nearly one-in-ten prescriptions written "off-label" in Canada lacked "strong scientific evidence" to support their prescribing, reports Health Day News . Off-label prescribing refers to applications for medicinal products that are not approved on its regulatory agency-approved label. In Canada, prescription drugs are regulated by Health Canada. The study, led by Dr. Tewodros Eguale of Mc...
  • Group Calls for EU Pharmacovigilance Regulations to Cover Unlicensed Medications

    A coalition of patient groups is calling for the inclusion of unlicensed medication in the next version of the Pharmacovigilance Directive , reports The Pharma Times . The call, led by the European Alliance for Access to Safe Medicines (EAASM), is in response to reports of adverse events occurring with off-label drugs, including Avastin (bevacizumab). "The Alliance says urgent action is needed to address patient safety issues around the use of unlicensed and off-label...
  • Study: Patients Often Unaware of Off-Label Prescribing Risks

    A study of 150 European patient groups conducted on behalf of the Irish Patients Association (IPA) has found that patients are usually not made aware that the medication they have been prescribed is off label or how to respond to off-label side effects, reports The Pharma Times . Sixty-six percent of groups polled said that their patients were not always aware that the prescribed drug product was off-label, while 12% said that none of their patients were ever aware if t...
  • FDA Releases Order to Protect Antimicrobial Drug From Use in Food Animals

    The US Food and Drug Administration today released an order, titled, " New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition ", that is aimed at prohibiting the off-label use of cephalosporin antimicrobial drugs in certain food-producing animals. The agency found that off-label use of the antimicrobial in food-producing animals was likely to be unsafe and represent a risk to the public. The rule follows an attempt to regulate the antimi...