• Regulatory NewsRegulatory News

    FDA to Provide Guidance on Use of Economic Information, Responses to Unsolicited Requests

    US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information. Background The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guida...
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    Do 'Distractions' in DTC Advertising Affect Patient Risk Perception? FDA Wants to Know

    The US Food and Drug Administration (FDA) has put the finishing touches on a proposed eye-tracking study intended to assess how patients assess the benefits and risks of direct-to-consumer (DTC) drug advertising when subject to on-screen "distractions." FDA has conducted similar research in the past, it notes in its 27 May 2014 Federal Register announcement. Prior eye-tracking research determined that consumers understand drug risks better when they are simultaneously ...
  • FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think)

    Watch a drug advertisement in the US-any one, really-and one thing you're unlikely to hear any mention of is the drug's cost. That's not always an accident, as the myriad of insurance companies, co-pays, state insurance programs, private assistance programs, coupons and other incentives mean that the true cost of a drug is rarely seen by consumers and is rarely the same for two people. But assume, for a moment, that such an instance existed-that a drug ("Drug A") cost ...
  • FDA Website Knockoff Markets Non-FDA-Approved Products

    In the mid-1990s, when "The Internet" was still in its infancy and government institutions were just beginning to develop an online presence, the world got perhaps its most notable look at how some purveyors will seek to profit off of website confusion. Twenty years later, though, it's still a problem, including for US healthcare product regulators. Background The problem then, as now, is that many people aren't always sure about which domain name suffix- .com, .org, .g...
  • FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies

    In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, leaving consumers more confused than informed. Now the pharmaceutical industry is weighing in on FDA's call for comments, supporting both its call for additional research and its goal of easing current requirements. Background At present, companies are required to present th...
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    “Let’s Play Ball:” One Regulatory Reviewer’s Guide to Effective Teamwork

    After a day of reviewing promotional materials at work, I was unwinding at home-flipping through television channels-when I came across a baseball game and thought, "Wow, are we all playing the same game?" I admit I am not an expert at baseball, but I could not help but see some similarities between the game and the world of pharmaceutical advertising and promotion. Bear with me while I try to explain. Imagine…the advertising agency "pitches" an idea to marketing....
  • In Rare Warning Letter, FDA Hits Company for Making Unapproved Claims About Device

    The US Food and Drug Administration (FDA) this week sent a rare Warning Letter to a medical device manufacturer chiding it for promoting its product for a purpose not approved by the agency. The 26 February 2014 Warning Letter to NeoMedix Corporation references the company's Trabectome High Frequency Generator, a device cleared earlier for use with compatible electrosurgical instruments in low-power microsurgical applications for the removal, destruction and coagulation...
  • FDA Releases Guidance on Use of Scientific and Medical Literature for Promotional Purposes

    A new draft guidance document released by the US Food and Drug Administration (FDA) aims to clarify the ways in which a pharmaceutical or medical device manufacturer may use scientific and medical literature to promote its products, even if the literature doesn't conform to the product's FDA-approved uses. Such practices straddle a fine line between marketing and commercially protected free speech. FDA has long regulated the dissemination of company-sponsored or -generat...
  • FDA Releases (its Other) Social Media Guidance

    It may not be the social media guidance members of the pharmaceutical industry have be clamoring for, but the US Food and Drug Administration (FDA) today released a draft guidance document that offers some insight into how the agency thinks companies should use-and not use-social media channels. Background The pharmaceutical industry's advertising and promotional materials are tightly regulated by FDA and the Federal Trade Commission (FTC), the latter of which has veste...
  • Analysis: OPDP More Likely to Issue Warning Letters if Drug has Black Box Warning

    Assume for a moment that you're a manufacturer of a pharmaceutical product, one with recognized benefits but enough potential risks to warrant a Boxed Warning on your product's label. Now here's a question for you: Is your product more likely or less likely to eventually receive a Warning Letter from the US Food and Drug Administration (FDA) if you commit an advertising violation relative to a regularly-labeled product? If you answered in the affirmative-that is, mo...
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    Use of Testimonials and Endorsements in Prescription Drug Advertisements

    Testimonials and endorsements made by patients, healthcare professionals and celebrities are widely used in prescription drug advertising and promotional labeling. The evidence of return on investment from endorsements is inherent through their perpetuity in advertising for drugs and other commodities. For the purpose of this article, endorsements and testimonials will be considered synonymous, with the word "endorsements" used to describe both. Endorsements are defined b...
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    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...