• FDA's 'Bad Ad' Program Marks Second Year of Operation

    The US Food and Drug Administration's (FDA) Bad Ad Program, an effort to encourage physicians and other healthcare providers to report "suspected untruthful or misleading prescription drug promotion," is doing some advertising of its own. In a "Year End Report" released this week, FDA's Office of Prescription Drug Promotion (OPDP) said it spent "significant time and resources" during the second year of the program's inception to increase the exposure of the Bad Ad progra...
  • Valeant, Lundbeck Warned for Leaving Warnings out of Promotional Video

    US regulators have sent pharmaceutical manufacturer Valeant Pharmaceuticals an untitled letter after finding a promotion for its Huntington's disease-treatment drug Xenazine omits "material facts," including risk information, while overstating the efficacy of the drug. Valeant does not itself market the drug, which is marketed by Lundbeck, but does own the new drug application under which the product is marketed . In its 20 June letter to Valeant, the US Food and Drug...
  • Pfizer Receives Untitled Letter for Presentation of Drug Risks

    • 06 July 2012
    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) recently sent an untitled letter to pharmaceutical manufacturing giant Pfizer for allegedly marketing its extended-released antibiotic Zmax (azithromycin) using misleading, unproven and incomplete information. The 19 June untitled letter focuses on a brochure produced by Pfizer to promote Zmax. FDA claims the company minimized several risks factors-including severe and potentially f...
  • US Regulators Move Ahead With Planned Study on DTC Marketing

    How long does it take for the US Food and Drug Administration (FDA) to get a study up and running? For at least one previously-proposed study on promotional advertising, nearly two years. Since September 2010, FDA has been looking to conduct a study on consumers to assess the effects of promotional offers in direct-to-consumer prescription drug print advertising. In its 22 September 2010 Federal Register posting , FDA proposed the study as a way to look at how coupons...
  • Watermelon and Web-links Form Basis of Drug Promotion Complaint Against Swedish Company

    • 25 June 2012
    [ Editor's note: an earlier version of this story indicated the website was run by Quintiles. Quintiles is only the marketing representative of Swedish Orphan Biovitrum AB in the US, and was not responsible for the website. ] The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a warning letter to Swedish Orphan Biovitrum AB for allegedly making misleading claims regarding the safety and efficacy of Kepivance (palifermin) on a w...
  • Group to FTC: Merck's Marketing Tie-ins Violate Advertising Regulations

    • 21 June 2012
    Merck & Co might be wishing it had just stuck with Antonio Banderas to market its allergy products. In a sharply-worded letter to the US Federal Trade Commission, a group of public advocacy groups is demanding the agency investigate Merck's use of Dreamworks Animation's characters from the movie Madagascar III: Europe's Most Wanted to market its over-the-counter (OTC) Children's Claratin. "Dreamworks licensed its Madagascar characters for use on a number of child...
  • Disease-information Enhanced Advertisements May Be Misleading Consumers, Says FDA

    The US Food and Drug Administration (FDA) seems to be in favor of un-branded disease awareness commercials. In a Federal Register posting on 20 June, the agency says it is aware of research saying consumers find the advertisements both more helpful and less intrusive than branded product commercials, which is in line with the agency's goals to "encourage the communication of accurate health messages." What it's not supportive of, however, is when disease information is ...
  • FDA Gets Permanent Director for Reorganized Surveillance 'Super Office'

    The US Food and Drug Administration (FDA) has announced the promotion of Gerald Dal Pan, MD to the position of permanent director of FDA's Office of Surveillance and Epidemiology (OSE), where Dal Pan had been serving as acting director. OSE had recently undergone a reorganization that transformed it from a relatively minor office within the Center for Drug Evaluation and Research (CDER) and into a so-called "super office." Dal Pan has served as the head of OSE since 2005...
  • France Issues New Advertising Guidelines

    • 04 June 2012
    France's recently-formed National Security Agency of Medicines and Health Products (ANSM) has announced the launch of new advertising guidelines, which it says will transition the agency from a passive verification system to a system in which advertising must be approved before publication. In its 31 May explanation of the "new methods of control" for advertising, ANSM notes requests for prior authorization must be sent to the agency per Article L.5122-9 of the Code of P...
  • PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

    The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech. FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, " New FDA Draft Guidance on DTC Television Advert...
  • FDA Calls out Pharma Company for Repeated 'Violative' Marketing Practices

    The US Food and Drug Administration (FDA) released a warning letter sent to Octapharma USA, Inc on 10 April 2012, in which the agency scolds the company for numerous marketing violations. FDA's Advertising and Promotional Labeling Branch (APLB), located within the Center for Biologics Research and Evaluation, reviewed some of Octapharma's advertisements within two publications released in December 2011. FDA rapped Octapharma for "false and misleading" advertisements aft...
  • Report: Regulations Banning Industry Gifts in India Still Taking Shape

    A set of long-awaited pharmaceutical marketing rules preventing companies operating in India from providing free products to doctors in order to drive sales has failed to take shape a year after the regulations were first proposed, reports The Economic Times of India . "More important policy matters such as drug pricing have taken precedence, pushing the marketing policy to the back seat," a source told The Times , adding it is still in early development stages. The m...