• 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...
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    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 Calls for Changes to Drug Advertising in Hopes of Increasing Patient Understanding

    The pharmaceutical advertising you see in magazines and newspapers will soon include less information in the hopes of better conveying what the actual risk of the drug is, the US Food and Drug Administration (FDA) announced today. Background The change represents a substantial shift in policy for the agency, which has traditionally favored the inclusion of as much risk information as possible in its advertising. For example, FDA's Office of Prescription Drug Promotion (...
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    TrackersTrackers

    FDA Drug Advertising Study Tracker

    The US Food and Drug Administration (FDA) frequently studies consumer behavior, particularly as it relates to how members of the public (and medical professionals) understand pharmaceutical advertising. Our FDA Drug Advertising Study Tracker keeps tabs on these studies and explains what they're trying to accomplish in plain terms.   Date Topic Study Summary January 2012 Corrective Advertising Study to assess whether and how corrective advertising—used to cor...
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    FDA Considers Allowing Drug Companies to Drop Some Warnings in TV Commercials

    The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them. Background The study, first proposed in February 2014, is meant to address a regulatory hypothesis: That consumers, bombarded with a long list of side effects, might have a difficult time deciding between drugs. In the s...
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    FDA Plans Huge Study on How Public Understands Drug Risk

    The US Food and Drug Administration (FDA) is out with yet another proposed study on direct-to-consumer prescription drug advertising—its third proposed study in as many weeks—this time focusing on how patients understand the risks and benefits of drug products. Background FDA frequently studies consumer behavior as it relates to drug advertising. An overview of recent studies is as follows: Date Topic Study Summary January 2012 Corrective Advertising Study...
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    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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    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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    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...