When the space of characters is limited, can a link to risk information be enough for drugmakers advertising their products on social media like Twitter? That’s the question the US Food and Drug Administration (FDA) asked last November and now industry is offering their opinions on the planned studies. As part of its planned study, FDA said on 7 November that it plans to conduct four studies, two involving Twitter and two using Google sponsored links, to determine how ...

Do the mucous monsters or the little pink, intestine-like cartoon really help consumers learn more about new treatments? Or are these and other animated characters in direct-to-consumer (DTC) pharmaceutical ads just a ploy to grab your attention? The US Food and Drug Administration (FDA) wants to find out with new research, but drug companies, according to comments unveiled on Monday, are hesitant to see how such limited research could actually lead to new policies or g...

As the boundaries between the clinic, the research lab and industry continue to shift, researchers are calling on the US Food and Drug Administration and other similar regulators worldwide to tread carefully in how they effectively facilitate the practice of precision medicine. In an article published online this week in the Journal of Law and the Biosciences , titled “Precision medicine: drowning in a regulatory soup?” a group of mostly Australian researchers note that...

Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...

Direct-to-consumer (DTC) advertising for pharmaceuticals has been a hot topic recently as federal and state officials have questioned their utility, particularly as the US and New Zealand are the only two countries in the world that have them. Now, the US Food and Drug Administration (FDA) is looking to survey patients about their experiences with DTC drug ads. The survey will question respondents about their knowledge of FDA's authority over prescription drug advertisi...

The US Food and Drug Administration (FDA) called out another direct-to-consumer (DTC) genetic testing company on Monday over an unapproved test, this time going after one recently made available at the drugstore chain Rite Aid. According to the letter from FDA, the swab tests from Tennessee-based Harmonyx, a College of American Pathologists-accredited and Clinical Laboratory Improvement Act-certified genetic testing laboratory, are meant to help patients determine if the...

Physicians at the American Medical Association (AMA) on Tuesday called to ban direct-to-consumer (DTC) advertising for drugs and devices because of the negative impact of the commercially driven promotions. Physicians revealed concerns that the increase of ads in the US (only the US and New Zealand allow DTC advertising for drugs and devices) is driving demand for newer, more expensive treatments even though less-costly alternatives may be more effective. AMA Board Chai...

Last week, the US Food and Drug Administration (FDA) sent letters to three genetic testing companies for marketing unapproved direct-to-consumer (DTC) tests. The letters are addressed to three companies: DNA4Life, DNA-CardioCheck, Inc. and Interleukin Genetics, Inc., which FDA says are marketing genetic tests to consumers without being cleared. In each of the letters, James Woods, FDA Deputy Director for the Patient Safety and Product Quality Office of In Vitro Diagnost...

As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...

This article discusses an evolving approach to present prescription drug risk information to consumers based on recent guidances released by the Agency. In recent years, there has been an increased focus from the US Food and Drug Administration (FDA) on consumer directed promotional materials. Nearly all of the active research projects at the Office of Prescription Drug Promotion (OPDP) are focused on how consumers respond to the type or presentation of risk inf...

The US Food and Drug Administration (FDA) says it is planning a new study to assess whether older Americans are able to adequately hear all of the risks presented in televised pharmaceutical advertising. Background The study, announced in a 24 June 2015 posting in the Federal Register , is somewhat similar to other direct-to-consumer (DTC) drug advertising studies proposed by FDA in the last few years, including studies on how adolescents understand risk in drug ad...

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 (...