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  • Feature ArticlesFeature Articles

    Regulatory Issues in Digital Pharmaceutical Communications in the EU--Part 1

    • 25 April 2013
    The use of eHealth systems and services-defined as healthcare practice using the Internet-offers great potential to enhance patient safety by avoiding medical errors and improving communications, while reducing costs and inefficiencies in areas such as record keeping. 1 Because of this potential to improve health systems, the use of eHealth technology to aid in medical diagnosis and treatment and support pharmaceutical communication will likely become increasingly commo...
  • Rare Multi-Agency Warning Letter Slams Flu Product

    The US Food and Drug Administration (FDA) has issued a rare multi-agency warning letter to a marketer of a product claiming to give patients protection against the influenza virus. The letter, sent on 24 January 2013 to Flu and Cold Defense LLC ('FCD'), was sent in conjunction with the Federal Trade Commission (FTC). Both FDA and FTC regularly work together on matters related to advertising, but the joint warning letter is extraordinarily rare, as FTC ordinarily defers...
  • 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...
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    Comparative Claims: Learning from FDA Warning and Untitled Letters

    Many promotional materials contain comparative statements that suggest one product is superior to others on the market. These presentations often involve comparisons of the products' efficacy or safety profiles, but they may also compare indications, dosages, patient preferences, price and so on. Use of comparative claims is not without risk, however. In recent years, more than a third of all Warning and Untitled Letters issued by the US Food and Drug Administration's (...
  • FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

    • 23 October 2012
    The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc . after regulators said an inspection found deficiencies that caused the products to be adulterated under federal law. AN calls itself an international, specialist manufacturer of all-natural nutritional supplements. FDA's warning letter, sent 16 October 2012 and published on 23 October, largely concerns violations of federal c...
  • Under Fire, Abbott Suspends Marketing Program in India

    • 17 October 2012
    Officials with Abbott Laboratories have announced the suspension of a controversial policy that has stoked controversy with critics who claim the company is buying favors from prescribing physicians by lavishing them with valuable gifts, reports Reuters . In an email obtained by the news organization, Abbott Healthcare, a subsidiary of its North American counterpart, said it would henceforth only distribute approved literature to prescribing physicians. "No brand ...
  • Crackdown on Cosmetic Marketing Claims Expands as Avon Sent Warning Letter

    The US Food and Drug Administration (FDA) has taken aim at another of the cosmetic industry's giants over the use of marketing claims reserved for approved pharmaceutical products-its fourth warning to such a company in the last two months. The agency had previously sent warning letters-advanced notices of intended regulatory action-to L'Oreal subsidiary Lancôme USA , Nevada-based Andes Natural Skin Care and New Jersey-based Janson Beckett , all of which were a...
  • Feature ArticlesFeature Articles

    FDA Regulation of Healthcare Product Advertising on Social Media

    Social media offers exciting new approaches to marketing products, but the medical products industry has been slow to participate. Social media communications can be daunting for many reasons: it is public, continuous, interactive and global, and there are often extreme space limitations. Many in the medical device industry point to a lack of US Food and Drug Administration (FDA) guidance 1 as one of the main reasons for caution. In a survey by Massachusetts trade asso...
  • FDA Untitled Letter Chides Genentech Promo for Inadequate Substantiation of Claims

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Genentech over marketing materials used to promote its drug Tarceva (erlotinib), used to treat metastatic non-small cell lung cancer (NSCLC). OPDP's letter references a visual aid entitled, " Improving Outcomes in First-Line Advanced Pancreatic Cancer ." The advertisement depicts an adult and child in a mostly-horizontal hourglass on a beach, loungi...
  • New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland

    Pharmaceutical and medical devices industries doing business in Ireland may soon find it more difficult to market their products under new guidance developed by the Irish Medical Council aimed at redefining the terms of acceptable conduct between doctors and members of industry. The guidance, a supplement to earlier guidance on the same topic, is specifically aimed at reducing real or perceived conflicts of interest, the majority of which are caused by gifts and othe...
  • 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...
  • FDA Cracks Down on Spurious Marketing Claims for Cosmetic Products

    The US Food and Drug Administration (FDA) is increasingly cracking down on the marketing claims used by some cosmetic companies, firing off at least three warning letters in as many weeks regarding allegedly unfounded claims used to market various products. In an opening salvo, released in the form of an 11 September warning letter , FDA alleged French cosmetic giant L'Oreal's US subsidiary, Lancôme USA, was using a number of improper marketing claims that caused ...