For the first time this year, the US Food and Drug Administration's (FDA) pharmaceutical advertising watchdog, the Office of Prescription Drug Promotion (OPDP), has issued a warning to a company for allegedly trying to promote a product for uses for which it had not received FDA approval. The warning, known as an "Untitled Letter," is less serious than the agency's more formal Warning Letters in that it does not threaten immediately regulatory enforcement action if a com...

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 (...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...