• Regulatory NewsRegulatory News

    New Blood Clot Warnings Added to Labels of Testosterone Products

    The US Food and Drug Administration (FDA) yesterday said it will require manufacturers of testosterone products about an increased risk of venous blood clots, known as venous thromboembolism (VTE)—the latest warning for a class of drugs that has seen no shortage of scrutiny from regulators and researchers alike. Background Testosterone products, commonly used to treat low levels of testosterone in men, or "low-t," have long been associated with higher risks of so...
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    FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

    A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...
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    Second Major Sleep Drug Associated With Impaired Driving as FDA Dials Back Recommended Dosing

    The US Food and Drug Administration (FDA) has again issued a warning about a sleep drug, this time requiring a labeling change for the popular sleep drug Lunesta after data indicated that some patients experienced long-lasting effects that could impair their ability to function, even after a full night's sleep. Background Sleep drugs have long been on FDA's radar, primarily due to their association with impaired driving. The concern has been that some patients respond a...
  • Feature ArticlesFeature Articles

    Book Excerpt: FDA Requirements for Prescription Drug Promotion

    RAPS has just published FDA Requirements for Prescription Drug Promotion, written by John Driscoll, an industry veteran who is now a consultant specializing in drug promotion and labeling. In keeping with the September Regulatory Focus theme of advertising, promotion and labeling, following is "Chapter 1 Prescription Drug Labeling," from the book. For more information on the book and the author, see the i nterview with Driscoll in Under RAPS . Introduction Understandi...
  • FDA Looks to Update, Improve Labeling of Existing Drug Products

    In February 2013, the US Food and Drug Administration (FDA) announced its intent to launch a new initiative aimed at voluntarily converting the majority of currently marketed pharmaceutical and biological drugs to a consistent standard for content labeling, noting that many products have been grandfathered in to outdated standards that put consumers at risk. Now the agency is looking to get that program started, issuing a solicitation to find a partner willing to help it ...
  • Health Canada Calls for New Drug Regulations Emphasizing Labeling Clarity

    Drug labels can be poorly written, confusing or otherwise dangerous - and that's assuming you're a proficient reader literate in health care terminology. In response to the difficulties and safety risks assumed by consumers confronted with unclear prescription drug labeling, Health Canada has announced it will launch a "Plain Language Labeling Initiative" to require drug labeling to be clear to consumers. Background Public health officials around the globe have long fla...
  • FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry recommending changes to the way companies place safety information on container labels and cartons, saying the changes are intended to reduce the number of medication errors. Background A 2006 report by the US' Institute of Medicine (IOM), a government think tank of sorts focused on healthcare, found that a major source of medication errors could be attributed to product labeling. ...
  • FDA Guidance Provides Framework for Testing and Labeling Scored Drug Tablets

    The US Food and Drug Administration (FDA) has published a new final guidance document on the criteria that sponsors of new and abbreviated drug applications (NDA/ANDA) should use to evaluate tablet that have been scored to allow for the product to be split into two or more pieces. Background Many products have scoring marks to allow consumers or their healthcare practitioners to split a tablet, thereby allowing the consumption of the product at controlled, lower doses w...
  • Repeat Deficiencies Form Basis of Warning Letter to Veterinary Pharmaceutical Manufacturer

    • 13 December 2012
    A number of recurring deficiencies form the basis of a warning letter sent to a St. Louis veterinary drug manufacturing facility. The company, Performance Products Inc (PPI), was accused of "significant deviations of Current Good Manufacturing Practice (CGMP) regulations" in the 20 November 2012 letter. PPI manufactures a number of products aimed at bovine and equine species, with most of those products being probiotic in nature. The company's website boats about it...
  • In Landmark Ruling, Court Sees Off-Label Marketing as Protected Free Speech

    • 04 December 2012
    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
    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...