FDA investigates direct to consumer adverts

FDA to regulate direct-to-consumer genetic tests.

began, genetic tests were available for about 100 diseases — most of them caused by just one faulty gene, such as the mutations that cause Tay-Sachs and cystic fi brosis. As genomic technologies matured and sequencing became less costly, companies began developing tests for a wider range of complex, multigenic, common diseases. These were initially offered by laboratories used by physicians, bu...

FDA considers tightening regulations for direct-to-consumer advertising.

In August, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) sought to curb growing public criticism over its consumer advertising practices by releasing voluntary advertising guidelines. The document stated that drug advertising should serve the public health by “ increasing awareness about diseases ” and “ educating patients about treatment options. ” The voluntary PhRMA gui...

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.   Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a...

FDA investigates the safety of brain perfusion CT.

Still the Great Debate – “Fair Balance” in Direct-to-Consumer Prescription Drug Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for prescription direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about th...