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  • Feature ArticlesFeature Articles

    Legal Issues in Digital Pharmaceutical Communication in the EU--Part 3

    In March 2011, the European Commission launched a public consultation on an updated eHealth Action Plan for the period 2012-2020 1 , which had been called upon by the Council Conclusions on Safe and Efficient Healthcare through eHealth of December 2009 2 , and superseded the first plan adopted in 2004. Similarly, the US Food and Drug Administration (FDA) promotes the development of mobile medical apps that provide consumers and healthcare professionals with valuable he...
  • Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer

    Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been experiencing massive shortages since 2011, have been resolved. But with the resolution of that shortage has come something else that has been in short supply in recent months as well: regulatory scrutiny for the drug. Background In late 2011, regulators became aware of mounting...
  • Changes Coming to Australian Advertising Rules

    Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed changes to the current regulatory framework for the advertising of therapeutic goods to the general public. The TGA noted that it is not proposing any changes relating to the advertising of prescription and certain pharmacist-only medicines to the general public, which will remain prohibited in Australia. The objectives of the proposed reforms are to: Improve the timeliness and ...
  • 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...