• Regulatory NewsRegulatory News

    Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out

    The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks. Background FDA frequently studies consumer behavior as it related to drug advertising. An overview of recent studies is as follows: Date Topic Study Summary January 2012 Corrective Advertising Study to assess wh...
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    Barraged by Drug Ads? FDA Wants to Know How That Makes You Feel—About the Drug

    There's no shortage of pharmaceutical advertising on US television stations. Watch a TV show for long enough, and chances are good you might even see the same drug ad several times. Now the US Food and Drug Administration (FDA) says it's interested in studying whether consumers who view the same drug ad multiple times perceive the safety or efficacy of the advertised drug differently than those who view it only once. Background FDA frequently undertakes studies on direc...
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    In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims

    The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny. The Letter In its so-called " Untitled Letter " to New Jersey-based Sciecure Pharma, FDA's Office of Prescription Drug Promotion (OPDP) said i...
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    FDA Sends Warning Letter Over Anesthesia Drug's Claims, but Company Defends Ads

    New Jersey-based pharmaceutical manufacturer Pacira Pharmaceuticals has been sent a Warning Letter by the US Food and Drug Administration (FDA) after the regulator took issue with the way in which the company was promoting its analgesic drug Exparel. FDA's letter, dated 22 September 2014, references "educational technique flashcards" and a journal advertisement the agency said created the impression that Exparel has been approved for "new uses for which it lacks approval...
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    DTC Broadcast Advertisements: The Evolution of Major Statements

    Direct-to-consumer (“DTC”) advertising has a long, robust regulatory history, mostly rooted in debates over the pros and cons of promoting a prescription drug directly to consumers. 1 Critics have issued various condemnations about DTC, contending that DTC advertisements, to name a few concerns, increase drug costs, misinform patients rather than educate them, overemphasize a drug’s benefits, and minimize risk information by limiting the amount of drug risks included, pr...
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    Do Distractions in Drug Ads Put Consumers at Risk? FDA Study to Find out

    The US Food and Drug Administration (FDA) has received approval to go forward with a proposed study to study the effects of "distractions" in direct-to-consumer drug advertising, which it hypothesizes may reduce consumers' ability to remember risk information about a product. Background FDA announced the proposed study in May 2014, saying that while "previous research has shown that factors such as multiple scene changes and music in advertising can be distracting," t...
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    Comparative Claims in Advertising Make Drugs Seem Safer, More Effective

    Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug Administration (FDA) and published this month. Writing in the journal Social Science & Medicine , FDA Social Science Analyst Amie O'Donaghue and colleagues with FDA's Office of Prescription Drug Promotion (OPDP) and RTI International...
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    FDA Targets Companies for Facebook 'Likes.' Is Twitter Next?

    Over the last two years, two companies have found themselves in the sights of the US Food and Drug Administration (FDA) after the regulator warned them for violating federal advertising regulations by "liking" unapproved claims on the social networking website Facebook. But while FDA's warnings have yet to set off a wider crackdown on pharmaceutical companies, recent changes to the social media platform Twitter have raised the possibility that similar attention might so...
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    Pharma Company's Phone Script Violates Advertising Regulations, FDA Says

    Those who closely track so-called "Untitled Letters" authored and sent by the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) know the letters most frequently reference promotions made over two types of media: the Internet and print media. But in an unusual letter sent last week by OPDP, the office indicated that it's still keeping an eye on promotions made using a decidedly traditional format: the telephone. An Untitled Letter In i...
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    Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out

    How do teenagers and young adults interpret messages contained in direct-to-consumer pharmaceutical advertisements? The US Food and Drug Administration (FDA) wants to know, and is now moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising. The study was first announced in October 2013 . At the time, FDA noted that adolescents may understand drug advertisements ...
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    FDA Chides Gilead for Google Advertisement, but is the Company Entirely to Blame?

    Less than a month after the US Food and Drug Administration (FDA) first unveiled its long-awaited social media guidance documents , the agency has chided Gilead Sciences for its misuse of a "text-limited" Internet platform covered by its guidance documents, Google Sitelinks. Background In July 2014, FDA released two guidance documents covering the use of social media. One of those documents, Internet/Social Media Platforms with Character Space Limitations— Pres...
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    LEAN In? Please Don't, FDA Tells Company in Letter Citing Double Meaning of Ad Campaign

    The US Food and Drug Administration (FDA) has issued an Untitled Letter to Citius Pharmaceuticals alleging that the company's website contains materials which create a misleading impression about the safety and efficacy of the company's weight loss drug, Suprenza. The letter, authored by FDA's Office of Prescription Drug Promotion (OPDP), is only the fourth sent by the agency this year for advertising-related allegations. But allegations contained within are largel...