The FDA: Serious Attempts at Consumer Awareness and Direct-to-Consumer (DTC) Advertising of Prescription Drugs

  • October 11, 2018
  • Ariana

While the use of DTC ads for prescription drugs remains controversial, the evidence is clear that direct-to-consumer advertising educates consumers about medical conditions, medical treatments, and prescription drugs benefits, side effects, and risks.


In fact the FDA established the Office of Drug Promotion (OPDP) Research for the express purpose of researching DTC to engage academic researchers, pharmaceutical companies, and non-profit groups.  Among other efforts, the program is focused on increasing consumer reporting of adverse events.


In 2004, the FDA received 21,653 direct reports, of which 3,885 (17.9%) were from consumers. In 2014, that number increased to 34,256 reports, of which 14,446 (42.2%) were from consumers.  Du et al. (2012) have suggested a positive relationship between direct-to-consumer (DTC) advertising and the reporting of adverse event reports.


After the enactment of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the inclusion of Title IX of FDAAA, which requires printed DTC advertisements for prescription drug products to include the following statement: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1–800-FDA-1088.” , there was an increase in consumer reported adverse events.  According to their calculations, about 0.24 more reports were made per month per drug.   Of those, approximately 65% could be attributed to the MedWatch number requirement.


Thus, more consumers report adverse events than ever before, and increasing the visibility of the platform helps ensure that more consumers are aware of and have the ability to report adverse events.


A 2016 study funded by OPDP aimed at further improving the impact of Toll-free number. An Empirical Examination of the FDAAA-Mandated Toll-Free Statement for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.


This effort to strengthen consumer is sure to continue.

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