• 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
    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...
  • New House Bill Would Allow Manufacturers to Label Products 'Cancer-Free'

    Newly-proposed legislation introduced in the US House of Representatives would allow companies to submit to a voluntary process to label their products "Cancer-Free" if they do not contain known carcinogens. The bill, The Cancer-Free Label Act of 2012 , was introduced by Rep. Ted Deutch (D-FL) and would establish a program within several federal agencies-including the US Food and Drug Administration (FDA)-to "permit the labeling of covered products that do not conta...
  • FDA Issues New Draft Guidance for Products Containing Acetaminophen

    The US Food and Drug Administration (FDA) has released new draft guidance pertaining to over-the-counter drug products containing acetaminophen, saying it will allow exceptions to a labeling rule under limited circumstances. Acetaminophen is commonly used in internal analgesic, antipyretic and antirheumatic (IAAA) drugs to relieve pain, but had also been associated with liver injury and stomach bleeding if used at high dosages. As a result of the associated adverse event...
  • 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 ...
  • Australia: Draft Guidance on Evidence to Support Indications for Low Risk Medicines

    Australia's Therapeutic Goods Administration (TGA) is seeking comment from interested parties on draft guidance Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants) . The draft specifies the type of evidence required to support indications made for listed (low risk) medicines (including weight loss products) and is intended to replace the Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for...
  • TGA Calls for Comments on Evidence Needed to Support Low-Risk Claims

    Australia's Therapeutic Goods Administration (TGA) announced 23 April it is looking for comments on its draft guideline outlining the types of evidence needed to support indications made for low-risk medicines. TGA's guideline, Evidence Required to Support Indications for Listed Medicines (excluding sunscreens and disinfectants) , is intended to replace an earlier guideline entitled, Guidelines for Levels and Kinds of Evidence to Support Indications and Claims for N...
  • 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: Poor Health Literacy Detrimental to Patient Health Outcomes

    A new study in the British Medical Journal has found that limited health literacy was associated with higher rates of death among study participants. The study tracked nearly 8,000 patients over the age of 52, and sought to understand the effects of health literacy on patient health. To do this, the study asked patients to read the label of a medicine bottle and answer four simple questions, such as the maximum number of days a medicine may be taken and situations req...
  • 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 Calls for Proposed Industry Labeling Standards

    The US Food and Drug Administration is proposing to study how to best standardize medical device labeling by polling healthcare providers and is calling on industry to generate recommended labeling formats and contents. FDA opened a comment period on the proposed study back in November 2011, and received comments from industry group AdvaMed questioning the utility of the study, the accuracy of the estimated burden, the validity of the methodology and the subject to be ...