• Feature ArticlesFeature Articles

    Evolution of Advertising and Promotion Review Systems

    This article addresses the evolution of review systems used for advertising and promotion materials. Promotional review and approval, at its root, is designed to ensure all marketing and sales materials for pharmaceuticals are compliant with established legal, regulatory and medical standards, as well as company policies and procedures. Pharmaceutical companies employ cross-functional teams applying standard principles of education and training and good judgment to eva...
  • Feature ArticlesFeature Articles

    Prescription Drug Advertising Versus Non-Advertising Promotion in China: Contrasting Regulation

    This article discusses the contrasts between regulatory oversight of prescription drug advertising and non-advertising promotion in China. On 1 September 2015, several new requirements for the regulation of prescription drug advertising in China were implemented. (1) Recent legislative amendments to China’s Advertising Law , (2) the first significant revision of the statute since 1994, and corresponding proposed revisions to review standards and administrati...
  • Feature ArticlesFeature Articles

    Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors

    This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies. Pharmaceutical companies promote their prescription drug products for a number of reasons, including to increase consumer awareness and the number of physicians prescribing the drugs and ultimately, to drive sales. Since these prescription products may carry serious risks, their promotion is r...
  • Feature ArticlesFeature Articles

    Stories From the Promotional Review Battlefront

    This article shares advertising and promotion experiences and presents strategies to improve a team's performance. It was the best of times, it was the worst of times… sounds like an ad/prom review team meeting. Many companies have a cross-functional team responsible for reviewing and approving advertising and promotional materials. This team and their meetings are known by many names: Promotional Review Committee (PRC), Medical/Legal/Regulatory (MLR), Medical/R...
  • Feature ArticlesFeature Articles

    The Evolving Approach of Presenting Risk Information to Consumers

    This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...
  • Regulatory NewsRegulatory News

    Court Sides With Amarin in Off-Label Suit

    On Friday, a New York Court sided with biopharmaceuticals maker Amarin in a suit against the US Food and Drug Administration (FDA) involving the off-label promotion of Vascepa. Background Vascepa was initially approved by FDA to reduce triglyceride levels in adults with severe hypertriglyceridemia. As reported by the FDA Law Blog , Amarin hoped to expand Vascepa's indication after learning that some doctors were using Vascepa off-label to treat patients with persist...
  • Regulatory NewsRegulatory News

    FDA to Study How Efficacy Information Affects Patients' Decisions in Drug Ads

    Does the inclusion of efficacy information in drug advertisements affect how patients perceive a drug, and if so, how would it affect their decision making? These are questions the Office of Prescription Drug Promotion (OPDP) at the US Food and Drug Administration (FDA) intends to answer through a two-part study just announced in the Federal Register. Background In addition to reviewing drug ads and promotional labeling "to ensure that the information … is not false ...
  • RAPS' LatestRAPS' Latest

    Experts to Offer Ad, Promo and Labeling Advice at RAPS Virtual Event

    Advertising and promotion of healthcare products in the US are strictly regulated by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). As the Internet and social media have become increasingly powerful forces in our everyday lives and important sources of information on personal healthcare decisions, regulators, marketers and healthcare companies all have had to contend with a slew of new challenges. On Wednesday, 3 June, RAPS...
  • Regulatory NewsRegulatory News

    FDA Making Changes to its Drug Advertising Review Process

    A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators. Background At present, all pharmaceutical advertisements aired or distributed by companies must be submitted to FDA's Office of Prescription Drug Promotion (OPDP)—formerly known as the Division of Drug Marketing, Advertising and Communication...
  • Regulatory NewsRegulatory News

    Do Price Comparisons Affect How Safe Patients Think a Drug is? FDA Plans to Find Out

    The US Food and Drug Administration (FDA) plans to study whether including pricing information on the label of a pharmaceutical product affects how consumers view the safety and efficacy of drug products, especially when comparisons are made between two drugs. Background Pharmaceutical advertising and labeling in the US are regulated by FDA, which ensures that certain information related to the safety and efficacy of a product is conveyed appropriately. The ultimate goa...
  • Regulatory NewsRegulatory News

    UK Regulator Releases Advertising Report, Complaints Down 32% from 2013

    The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its annual report on drug advertising. The agency says complaints are down versus previous years, but notes it received more complaints about advertisements made on websites and social media. Background In addition to adhering to the general advertising rules in the UK, companies are expected to voluntarily comply with the standards for drug advertising and promotio...
  • Regulatory NewsRegulatory News

    FDA's Advertising Regulators Cite Drug Company in First Warning of 2015

    For the first time this year, the US Food and Drug Administration's (FDA) pharmaceutical advertising watchdog, the Office of Prescription Drug Promotion (OPDP), has issued a warning to a company for allegedly trying to promote a product for uses for which it had not received FDA approval. The warning, known as an "Untitled Letter," is less serious than the agency's more formal Warning Letters in that it does not threaten immediately regulatory enforcement action if a com...