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...

As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...

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...

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...

This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.  Celebrities grab attention everywhere they go. In fact, it is what they are paid to do when they endorse a pair of sneakers or an underwear brand. Just look at William Shatner, best known as Captain James Kirk from Star Trek, who has everyone humming “Price-Line-Negoti-ator!” Or hear Samuel L. Jackson asking, “What’s in your wallet?” each time someone t...

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...

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 ...

The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising. Background The study, announced in a 24 June 2015 posting in the Federal Register , is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug ad...

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...

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...

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...

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...