title: Despite 2007 law requiring FDA hotline to be included in print drug ads, reporting of adverse events by consumers still low.
abstract: In 2007 the federal government began requiring drug makers to include in their print direct-to-consumer advertisements information for consumers on how to contact the Food and Drug Administration directly, either by phone or through the agency's website, to report any adverse events that they experienced after taking a prescription drug. Adverse events can range from minor skin problems like itching to serious injuries or illness that result in hospitalization, permanent disability, or even death. Even so, current rates of adverse event reporting are low. We studied adverse event reports about 123 drugs that came from patients before and after the enactment of the print advertising requirement and estimated that requirement's impact with model simulations. We found that if monthly spending on print direct-to-consumer advertising increased from zero to $7.7 million per drug, the presence of the Food and Drug Administration contact information tripled the increase in patient-reported adverse events, compared to what would have happened in the absence of the law. However, the absolute monthly increase was fewer than 0.24 reports per drug, suggesting that the public health impact of the increase was small and that the adverse event reporting rate would still be low. The study results suggest that additional measures, such as more publicity about the Adverse Event Reporting System or more consumer education, should be considered to promote patient reporting of adverse events.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA. dongyi.du@fda.hhs.gov
authors.forename: Dongyi
authors.initials: D
authors.lastname: Du
authors.forename: John
authors.initials: J
authors.lastname: Goldsmith
authors.forename: Kathryn J
authors.initials: KJ
authors.lastname: Aikin
authors.forename: William E
authors.initials: WE
authors.lastname: Encinosa
authors.forename: Clark
authors.initials: C
authors.lastname: Nardinelli
mesh_terms: D000328:Adult; D000329:Advertising / Q000331:legislation & jurisprudence* / Q000379:methods; D000368:Aged; D003256:Community Participation / Q000639:trends*; D016208:Databases, Factual; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D015277:Hotlines / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration